Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions
Phase: NA
Conditions: Thoracic Aortic Aneurysms, Thoracic Transections, Intramural Hematoma, Pseudoaneurysm, Thoracic Aortic Dissection
Sponsor: Rodney A. White, M.D.

 
 
 
 
 
 
 
Physician-Sponsored IDE for the Talent Endoluminal Stent 
Graft System for the Treatment of Thoracic Lesions 
 
 
NCT00597870 
 
 
March 8, 2002 
 
 
 
 
 

 
 
CONTENTS 
                                                                                    Page  
1. Report of Prior Investigations 
1.1 Introduction 
1 
1.2 Device Description 
5 
2. Investigational Plan 
 
 
5 
2.1 Purpose 
5 
2.1. I Name and Intended Use of the Device 
5 
2.1.2 Objectives of the Investigation 
5 
2.1.3 Duration of the Investigation 
6 
2.2 Protocol 
6 
           2.2.1 Inclusion Criteria 
 
7 
2.2.2 Exclusion Criteria 
9 
2.2.3 Withdrawal and Lost to Follow-up 
10 
2.2.4 Study Design 
11 
    2.2.5 Study Procedures 
12 
2.2.5.1 Subject Screening and Evaluation 
12 
2.2.5.2 Pre-procedure Evaluation 
12 
2.2.5.3 Sizing and Selection 
14 
                    2.2.5.3.1 Proper Sizing 
14 
                                2.2.5.3.2 Proper Selection 
 
15 
          2.2.5.4 Treatment 
 
16 
                     2.2.5.4.1 Implantation Requirements 
16 
                     2.2.5.4.2 Anticoagulation Therapy 
17 
                      2.2.5.4.3 Implantation Procedure 
18 
                     2.2.5.5 Pre-Discharge Follow-up 
20 
                   2.2.5.6 Post-Discharge Follow-up 
20 
                     2.2.5.7 Final Assessment 
 
21 
 2.2.6 Adverse Events 
21 
              2.2.6.1 Endoleaks 
23 
                     2.2.6.2 Conversion to Surgery 
24 
              2.2.6.3 Death 
25 
                     2.2.6.4 Other Adverse Events 
25 
       2.2.7 Scientific Soundness and Analysis of Data 
 27 
  2.3 Risk Analysis 
28 

 
2.3.1 Risks to the Patient 
28 
2.3.2 Manner in which Risks will be Minimized 
28 
   2.3.3 Justification of the Study 
29 
2.3.4 Patient Population 
29 
 
 2.4 Device Description 
 30 
2.4.1 Medtronic/Talent Stent-Graft 
 30 
     2.4.2 Medtronic/TaIent Placement System 
 30 
2.4.3 Medtronic/Talent Stent-Graft System 
 34 
 2.5 Monitoring Procedures 
 35 
2.5.1 Procedure for Monitoring 
  35 
       2.5.2 Name and Address of Monitor 
 35 
  2.6 Bibliography 
 35 
3. Manufacturing Information 
  37 
4. Investigator Information 
 37 
4.1 Name and Address of Investigators 
5. IRB Information 
 38 
6. Sales Information 
  40 
7. Labeling 
 40 
8. Informed Consent 
  40 
 
Attachments 
A. Medtronic, Inc. Reference Letter  
B. Published and Unpublished Articles 
C. Lifeline Registry Protocol 
D. Instructions for Use 
E. Case Report Forms 

 
F. Investigators Curriculum Vitae 
G. Sample Informed Consent 

1 
1. Report of Prior Investigations 
  1.1 Introduction 
A vascular aneurysm is a permanent, localized dilatation of a blood vessel at least 1 1/2 
to 2 times the normal vessel diameter. The aorta is the most frequent site for aneurysms, 
with approximately 10% of aortic aneurysms located above the renal arteries in the 
thoracic segment. (Coselli and LeMaire, 1995.) Thoracic aortic aneurysms (TAAs) are 
less common than abdominal aortic aneurysms, however, detection of TAAs is 
increasing, perhaps due to an aging population, increased diagnostic capability or an 
increase in prevalence. (Mitchell, Miller and Dake, 1997.) Ascending and transverse arch 
aneurysms each comprise 25% of TAAs; the remaining 50% occur in the descending 
thoracic aorta. The most common cause of TAA is medial degenerative disease of the 
aortic wall, responsible for most ascending aortic aneurysms and most fusiform 
aneurysms involving the descending aorta. Arteriosclerosis, commonly found 
superimposed on aneurysmal disease of other etiologies, frequently results in saccular 
aneurysms. Additional causes of TAA are dissection, aortitis, trauma, and infection. 
(Coselli  and LeMaire, 1995.) In cases of aortic dissection, which typically involves the 
descending thoracic aorta, the origin of the dissection is in the proximal descending aorta 
in about 25% of the cases. Traumatic TAA is typically caused by blunt chest trauma that 
produces partial aortic disruption. (Coselli, Buket and Crawford, 1996.) 
Untreated thoracic aneurysms can be life-threatening. As many as 78% of 
untreated patients with TAA die within 5 years after diagnosis, most often from 

2 
rupture of the aneurysm. (Pressler and McNamara, 1980.) Conventional surgical 
treatment, either tube graft replacement or patch aortoplasty, is a high-risk surgical 
procedure. Repair of the descending thoracic aorta is performed with a thoracotomy 
and cross-clamping of the aorta, with or without a shunt by-pass to maintain distal 
perfusion. Cardiopulmonary bypass is used to control rising blood pressure. 
(Najafi, 1994.) Mortality associated with surgical repair of the thoracic aorta ranges 
from 12% to more than 50%, depending on the urgency of the procedure, coexisting 
debilitating diseases or conditions, and the patient's general health. (Moreno-
Cabral, Miller, Mitchell, et al, 1984.) 
As an alternative to conventional surgery, a less invasive endovascular procedure 
has been developed that may be used to treat certain aneurysms. A collapsed stent-
graft, a metal stent coupled with a fabric graft, is introduced into the vasculature, 
advanced to the site of the aneurysm, and deployed to span the aneurysm. The 
device creates a new aortic lumen, excluding the aneurysm sac from blood flow 
while maintaining flow within the stent-graft, this less invasive technique is 
designed to prevent or decrease the need for open surgery, to reduce the need for 
blood transfusions, to decrease the use of anesthetics and other drugs, and to speed 
recovery time. A reduction in intensive care and total hospital stay should result, 
leading to an increased quality of life following the procedure and a reduction in 
cost. 
Experience in the endovascular treatment of thoracic aneurysms is limited. Miller, 
et al, have published results from a series of 108 patients with descending. 
   TAA treated with a (homemade) endoluminal stent-graft. (Mitchell, Miller and 
  Dake, 1997; Dake, Miller, Semba al, 1994; Skeens and Dake, 1997.) Atherosclerotic,     

3 
anastomotic, and post-traumatic true or false aneurysms and aortic dissections were        
treated. Complete aneurysm thrombosis and technical success was achieved in 103 of the 
108 patients. There were 10 deaths (9.25%) patients experienced perioperative strokes, and 
there were 4 cases of paraplegia. During an average follow-up of21.8 months (range 1 to 
57 months), there were 2 documented cases of stent-graft failure and 5 late deaths (more 
than 30 days post operative). (Skeens and Dake, 1997.) 
More recently, Nienaber et al prospectively evaluated the safety and efficacy of elective 
transluminal endovascular stent-graft implantation in twelve (12) consecutive patients with 
descending (Type B) aortic dissection and compared the results with conventional surgical 
repair in twelve (12) matched surgical control patients (Nienaber, 1999). Stent-graft 
treatment resulted in no morbidity or mortality, whereas surgery for Type B dissection was 
associated with four deaths (33%, p = 0.09) and five serious adverse events (42%, p = 0.04) 
within twelve (12) months. Stent-graft implantation was successful in all patients, with no 
endoleaks. There were no deaths or instances of paraplegia, stroke, embolization, side 
branch occlusion, or infection in the stent-graft group; nine patients had postimplantation 
syndrome, with transient elevation of C-reactive protein levels and body temperature as 
well as mild leukocytosis. All patients who received stent grafts recovered, as did seven 
(7) patients who underwent surgery for Type B dissection (58%, p = 0.04). The authors 
conclude that these preliminary results suggest that elective, non-surgical implantation of 
a stent-graft is safe and effective in selected patients who have thoracic aortic dissection 
and for whom surgery is indicated. Compared to standard surgical repair, this study 
supports the clinical utility of the stent-graft for the treatment of thoracic aortic dissection. 
      The first-generation Medtronic/Talent stent-graft has been investigated in a US DE Phase 
I pilot study involving 20 high-risk surgical candidates. The clinical study 

4 
described in this protocol is a study involving the second-generation 
Medtronic/Talent system.   Compared to the first-generation stent-graft, the 
Medtronic/Talent endoluminal spring stent-graft system also features an enhanced 
delivery system, which is designed to facilitate insertion and negotiation through 
tortuous and calcified vasculature. The first and second-generation devices are 
identical in every way except for the differences in graft material thickness and the 
presence of the system's new delivery system. The delivery system features a 
flexible tapered tip as well. as a flexible stainless-steel coil at the delivery-system 
catheter's tip, both of which facilitate negotiation through tortuous vessels and 
reduce the potential for device kinking. 
Since 1998, Harbor UCLA has treated 31 thoracic aortic lesions with the 
Medtronic Aneurx device, all of which have been part of commercial 
manufacturer DEs. A published review of 26 of these patients who were 
siY1ificant risks for surgical repair and who were implanted with the Aneurx 
thoracic stent-graft showed that 25 were treated successfully with no surgical 
conversions. Moreover, there was an overall decreased incidence of morbidity 
and mortality. (White, et al, 2001.) 
An additional 14 subjects were treated with the Medtronic/Talent thoracic device 
and 1 Gore device between June 1998 and January 2002, either on a compassionate 
or emergency basis. In our experience, the Talent device has been particularly useful 
for patients with descending aortic aneurysms and dissections with the only 
limitation being adequate access for the 22 to 27 French delivery catheters. 
 

5 
1.2 Device Description 
This study will utilize the most advanced generation Medtronic/Talent system 
including the enhanced delivery system. The information needed for the use of this 
device is available in Medtronic's DE G980116. (Please refer to the letter from 
Medtronic Inc. dated December 19, 2001 (Attachment A) granting the investigator 
permission to reference the IDE number.) The use of this device in this study will be 
for the same aneurysm morphology as described in the reference. 
2. 
Investigational Plan 
2.1 Purpose 
2.1.1 Name and Intended Use of the Device 
The Medtronic/Talent Stent-Graft System is a flexible, implantable vascular stent graft 
endoluminal device preloaded in a delivery system that is used to exclude 
 
thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, 
traumatic 
transections 
and 
both 
traumatic 
and 
degenerative 
pseudoaneurysms). 
The devices and intended use are described in IDE # G980116. 

6 
2.1.2 Objectives of the Investigation 
Both high risk and low risk patients with thoracic aortic lesions will be enrolled 
and treated. This includes patients with true thoracic aortic aneurysms (i.e., 
all    layers of the vessel are affected; generally, of atherosclerotic origins, 
thoracic dissections, penetrating ulcers, traumatic transections and traumatic 
and degenerative pseudoaneurysms). 
 
 
The primary objective of this investigational plan is to determine the safety of 
the Medtronic/Talent device when used to exclude thoracic lesions: true 
descending thoracic aortic aneurysms, dissections, penetrating ulcers, traumatic 
transections and traumatic and degenerative pseudoaneurysms from blood flow 
in high risk and low risk patients who are candidates for endoluminal repair. 
 
2.1.3  Duration of the Investigation 
Accrual of study subjects will occur over approximately 3 years with all 50 
subjects to be followed according to the Lifeline Registry of Endovascular Repair 
protocol for the life of the patient (Please see Attach C for the protocol). 
2.2    Protocol 
This study-will be conducted with high risk and low risk patients who are considered 
suitable candidates for endoluminal repair of descending thoracic aortic lesions 

7 
including those with true aneurysms, aortic dissections, penetrating aortic ulcers, 
traumatic transections and pseudoaneurysms (both traumatic and degenerative). Adult 
male and female patients who fulfill the inclusion/exclusion criteria listed below, are 
eligible for enrollment. 
2.2.1 Inclusion Criteria 
Subjects who participate in this study as study patients must fulfill the following 
criteria: 
•  Subject is >18 years of age. 

                                                            
8 
• Subject is not pregnant or lactating. Females of child-bearing potential must 
practice a reliable method of contraception. 
• Subject is diagnosed with one of the following conditions of the 
descending thoracic aorta. All conditions must be verified by diagnostic 
imaging [ultrasonography, computed tomography (CT), magnetic 
resonance (MRI) or angiography]. 
 a true (i.e., atherosclerotic) supraceliac aneurysm (fusif0Km or saccular 
type) with or without a CO-existing aortic dissection or penetrating aortic 
ulcer, 
▪ aortic dissection of DeBakey Type I or (Stanford A, proximal) in the 
absence of an aneurysm; or 
 penetrating aortic ulcer in the absence of an aneurysm; or 
 traumatic transection; or 
pseudoaneurysm — traumatic or degenerative (i.e., one that does not involve 
all layers of the vessel and is not atherosclerotic in origin. 
 
• Subject's anatomy is suitable for placement of the Medtronic/Talent Stent-
Graff, with a distinct proximal aneurysm neck of 10 mm or more in length 
and a distal aneurysm neck of at least 10 mm. 

 
 
 
                                                                                                                                   
9 
• Subject has a TAA that is dilated to > 5 cm in diameter, >1.5 times the 
diameter of the adjacent native/non-aneurysmal aorta or is symptomatic. 
• Subject has a proximal and distal aortic neck diameter >18 mm and < 42 mm. 
• Subject has an arterial access site, either peripherally or via infrarenal 
abdominal aorta that is adequate for introduction of the stent-graft delivery 
system. 
• Subject is competent to give informed consent. 
• Subject will be available for the periodic follow-up (surveillance) after the 
procedure. 
 
2.2.2 Exclusion Criteria 
Subjects who would participate as study subjects and who fulfill any of the 
following criteria may not participate in this study: 
• Subject has TAA with less than 10 mm proximal fixation length. 
• Subject has an aneurysm that would require exclusion by the stent graft of 
the segment of the aorta that gives rise to dominant spinal cord/intercostal 
arteries. 
• Subject has a lesion that prevents delivery or expansion of the device. 
• Subject has systemic infection or is suspected of having systemic infection. 
• Subject has a known mycotic aneurysm. 

 
 
 
                                                                                                                                                
10
• Subject is not available or is not willing to come back for periodic follow-up 
(surveillance) after the procedure. 
2.2.3 Withdrawal and Lost-to-Follow-up 
Patients may be withdrawn from the study for a number of reasons. The 
following is a summary of the possible reasons for withdrawal. 
Subjects may voluntarily withdraw from the study. The reason for 
withdrawal must be documented on the Termination CRF (Attachment E). 
After the implant procedure, some subjects may not return for follow-up 
visits. A minimum of three (3) attempts to contact such patients must be 
made. All attempts are to be documented on the Termination CRF. 
Subsequent to enrollment, if new information demonstrates that a patient does 
not meet the inclusion/exclusion requirements, the patient must be withdrawn 
from the study. The reasons for withdrawal must be documented on the 
Termination CRF. If such information is not discovered until after the implant 
procedure, the patient will still be followed for safety reasons but will not be 
included in the final analysis. 
   In some cases, an implant procedure will be initiated (i.e., an attempt to                   
pass or deploy the device) but is aborted prior to device deployment. Such patients 
maintain their enrollment status (since this is an intent-to-treat study) but need not 

 
 
 
                                                                                                                                   
11
be followed. On the other hand, if a patient is initially screened and enrolled, but 
no procedure is ever initiated, the patient is cancelled and his/her enrollment 
position is made available to another patient. 
             Patients who are enrolled in the study group and are converted to surgery due to peri- 
or post-implantation complications will be followed for a minimum of 12 months 
after enrollment. Conversion to surgery is documented on the Procedure CRF. 
 
2.2.4 Study Design 
This study is a prospective evaluation of patients receiving the investigational 
device to determine the proportion in whom successful implantation is achieved, 
as indicated by aneurysm exclusion and graft patency at implant, time of discharge, 
and 1-, 6-, and 12-months following implantation, and to determine the proportion 
of patients who experience adverse events during and after the implantation 
procedure, including comorbidities and overall mortality rates. The percentage of 
patients in whom technical and clinical success is achieved, and the percentage who 
experience serious adverse effects will be determined. Additional endpoints that 
will be evaluated are length of stay in intensive care following the procedure, total 
length of hospital stay and recovery time. 
               Patient data and follow-up information and images will be stored with the Lifeline 
Registry for Aneurysm Repair with periodic reports to the FDA up to the 5-
yearfollow-up supplemented with reports from the Registry database. 

 
 
 
                                                                                                                                                
12
2.2.5 Study Procedures 
2.2.5.1 Subject Screening and Evaluation 
Prospective subjects will be evaluated for enrollment in the study at the time 
they are considered to be candidates for repair of thoracic aortic lesions. Initial 
screening will include all diagnostic imaging tests performed as part of the 
patient's routine medical care. Spiral CT scan with possible angiogram is the 
minimum diagnostic imaging required to determine suitability for 
Medtronic/Ta1ent stent-gaff implantation. Prospective subjects who meet the 
inclusion/exclusion criteria specified in Sections 2.2.1 and 2.2.2 will be invited 
to participate in the study and give written informed consent. The patient will be 
given two consents: one for the implantation of the device and the other one for 
enrollment in the Endovascular Lifeline Prosthesis Registry. 
2.2.5.2 Pre-Procedure Evaluation 
Subjects who have elected to undergo implantation of the Medtronic/Ta1ent stent gaff will 
undergo pre-procedure evaluation. Proper sizing and selection of the 
device will be based on the measurements recorded on the TAA Vessel 
Measurement CRF. As noted previously, information that is required for subjects in the study 
group include spiral CT scan results, angiogram results, dimensions of the aneurysm and 
aorta, the type, morphology, and clinicopathology of the aneurysm, and pre-existing risk 

 
 
 
                                                                                                                                   
13
factors (Appendix E, Case Report Forms), as well as results of hematology, serum chemistry, 
and urinalysis laboratory testing, and current medications. 
The following must be performed prior to implantation: 
 physical examination, including femoral pulses, brachial and ankle blood 
pressure, and assessment of neurological functions; (Note that if any neurological 
deficit is observed, it must be documented and characterized on the Pre-operative 
Medical History CRF.) 
 medical history, including concomitant medications, and demographic 
information. 
 clinical laboratory tests: 
o hematology [CBC, platelet count, hematocrit, hemoglobin] 
o coagulation studies [prothrombin time, partial thromboplastin time, or 
activated partial thromboplastin time] 
o serum chemistry [sodium, potassium, chloride, bicarbonate, calcium, 
phosphorus, creatinine, glucose, total bilirubin, albumin, total protein, 
alkaline phosphatase, aspartate aminotransferase, serum glutamic 
pyruvic transaminase, lactic dehydrogenase, total cholesterol, 
triglycerides, blood urea nitrogen, uric acid]. 
▪ urinalysis 

 
 
 
                                                                                                                                                
14
▪ spiral CT (recommend a minimum of3mm slices, to adequately assess vessel 
dimensions) 
o angiography (with graduated marker catheter to measure/assess 
lengths and access vessel dimensions). 
        The results of all imaging studies will be verified according to mechanisms    
described in the Lifeline Registry for Endovascular Aneurysm Repair protocol. 
      2.2.5.3 Sizing and Selection of a Medtronic/Talent Endoluminal Stent-Graft 
Prior to the Medtronic/Talent stent-graft implant procedure, an angiogram, and a 
spiral CT scan, when appropriate, must be available to correctly measure and assess 
the aneurysm and vasculature. 
2.2.5.3.1 Proper-sizing of stent-graft 
For proper sizing of the Medtronic/Talent Endoluminal Stent-Graft, the information 
listed below must be measured and recorded on the TAA Worksheet CRF: 
 diameter of the proximal aortic neck. 
▪ diameter of the aneurysm.  
 diameter of the distal aortic neck; landing zone. 
▪ length of the posterior proximal aortic neck, from the proximal end of 
the aneurysm to the left subclavian artery, along the outer curve of the 
aorta. 

 
 
 
                                                                                                                                   
15
length of the anterior proximal neck, from the proximal end of the 
aneurysm to the left subclavian artery, along the inner curve of the 
aorta. 
 aneurysm length: area of the aorta to be excluded by graft. 
 length of the distal aortic neck, from the distal end of the aneurysm to the 
celiac trunk. 
▪ desired length of graft coverage. 
▪ access artery diameters 
 sketch/tracing of aneurysm, penetrating ulcer, dissection 
      The condition of the arteries that will be used to access the descending aorta must               
also be assessed and documented to determine if access to the aneurysm can be 
achieved with the Medtronic/Talent Stent-Graft System. Vessel diameter, tortuosity, 
stenosis, plaque, etc., will affect the ease of insertion. 
2.2.5.3.2 Proper selection of stent-graft design 
Selection of the open web or the bare spring design at the proximal and/or distal aortic end 
of the stent-gaff is dependent on the length of the proximal and distal aortic aneurysm 
necks and proximity to the subclavian artery and celiac axis respectively. In general, 
the bare spring design is intended for use in cases of short proximal and/or distal aortic 
aneurysm necks (e.g., less than 25 mm in length). The bare spring version is designed to 

 
 
 
                                                                                                                                                
16
allow placement of the bare spring across the left subclavian artery and the celiac axis that 
may be involved in the aneurysm. The open web design generally intended for use in cases 
of proximal and/or distal aortic aneurysm necks that are greater than or equal to 25 mm in 
length. 
 
2.2.5.4 Treatment 
2.2.5.4.1 Implantation Requirements 
Equipment needed to perform a Medtronic/Talent endoluminal stent graft implantation 
includes: 
 C-arm that can be angled freely, with the following: 
-high resolution fluoroscopy,  
high quality angiography, 
   -digital subtraction angiography.  
▪ puncture needles, Seldinger or single needles (18G or19G) 
▪ Angled Glidewire (180 cm 0.035" with torque device), or equivalent 
▪ Bentson wire (180 cm 0.035"), or equivalent 
▪ Amplatz Super Stiff wire (260 cm 0.035") or equivalent 
 Pigtail catheter (100 cm 5F multi-purpose)  

 
 
 
                                                                                                                                   
17
 Selection of Cobra 5F, Berenstein 5F, Tegtmeyer 5F or modified DAV 
(Cook) 
▪ 5F Simmons 1, 5F Chuang 2.5 
 Snare (nitinol goose neck, 10 —15 snare diameter) 
 Non-ionic contrast (approximately 300 mg/mL) 
 Angioplasty catheters (8 mm — 20 mm, depending on cases) 
Inflation device with pressure gauge 
Angio introducer sheaths 5F, 6F, 7F, 8F, etc. 
 High pressure angiographic injector and extension tubing 
 High pressure flush system 
 Stopcocks (selection of2-way and 3-way) 
 Sterile placement markers to mark skin, endovascular instruments, or monitor -
screens to plan precise graft placement 
▪ Surgical suite standby in case conventional surgical repair is necessary. 
2.2.5.4.2 Anticoagulation/Antiplatelet Therapy 
 Patients should be heparinized during the implant procedure. 

 
 
 
                                                                                                                                                
18
(Recommended activated clotting time is 200 - 300 seconds). An initial heparin bolus 
(or drip) of at least 5,000 units, followed by 1,000 units per hour bolus or drip is 
recommended. 
 
2.2.5.4.3 Implantation Procedure 
The following is a brief summary of the procedure. Refer to the 
Instructions for Use in Appendix D for further detail. 
During implantation of the Medtronic/Talent Endoluminal Stent-Graft, the pre-
implant angiogram and CT scan are used together with (on-the-table) intravascular 
ultrasound (IVUS), digital subtraction angiography (DSA), road mapping, and 
angiography for proper implant positioning. 
    The Medtronic/Talent Stent-Graft endoprosthesis is inserted by delivery catheter 
and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral 
artery, common iliac artery conduit, etc.) approach. The insertion method depends 
on each patient's anatomy and is determined by the Clinical Investigator. The 
introducer sheath and delivery catheter containing the stent-graft is inserted over a 
guidewire and advanced into the aorta and above the aneurysm. The introducer     
catheter should be rotated so that the connecting bar of the compressed stent-graft is 
in the best position to match with bends in the target vessel. 
With the delivery catheter in the correct position, the push rod is held stationary in 
one hand while the outer sheath is slowly withdrawn with the other hand. After 

 
 
 
                                                                                                                                   
19
verifying that the stent-graft is in the correct position, the introducer sheath is then 
withdrawn further until the stent-graft is completely deployed. The balloon maybe 
inflated along the full length of the implanted device to model the springs against 
the vessel wall and to unravel possible winkles in the graft fabric. 
After deployment of the stent-graft, angiography is performed to verify implant 
position and to check for the presence of endoleaks. Final arteriography is then 
performed to determine presence of leaks. If no leaks are detected, the introducer 
sheath and delivery catheter system are withdrawn from the patient. The entry site 
is closed by surgical means. 
If endoleaks are detected during the implantation procedure, the stent-graft should 
be re-ballooned to ensure that the device has been properly modelled against the 
vessel wall. Endoleaks present after remodeling should be covered with an 
extension cuff; all other leaks that remain after remodeling may be treated with a 
cuff or may be monitored postoperatively, as determined by the Clinical 
Investigator. If patent collateral vessels are suspected of causing leaks, the vessels 
may be embolized at the Clinical Investigator's discretion. Endoleaks that are 
successfully treated during the endovascular operative procedure are not 
considered a complication or adverse event. Section 2.2.6, Adverse Events, has 
more information on treating endoleaks. 

 
 
 
                                                                                                                                                
20
A Procedure form (Appendix E, Case Report Forms) will be completed after 
implantation has been accomplished. Fluoroscopy time and the amount of contrast 
material used will be recorded. 
2.2.5.5  Pre-discharge 
Prior to hospital discharge, a pre-discharge examination will be completed for all 
study group patients. This will include a physical examination and laboratory 
testing (including hematology, serum chemistries, and urinalysis). The spiral CT 
may be done at any appropriate interval within four weeks after the date of 
implantation. Any new (or worsened) neurological deficits observed post-
procedure require a neurological consult. 
2.2.5.6 Post-Discharge Follow-up 
     After hospital discharge, patients will be seen I, 6, and 12 months 30 days) and 
annually for life after the implant procedure with annual reports to be submitted to 
the FDA based on a 5-year data. Patients may also be seen for additional follow-up 
visits, if clinically appropriate. Post- 
Operative Assessment form (Appendix E) will be completed for each visit. 
At each post-discharge examination, patient status, vasculature and aneurysm status, 
and device efficacy will be assessed. Any new (or worsened) neurological deficits 
observed post-procedure require a neurological consult. If additional follow-up 
visits occur, information obtained at that visit will be recorded on the Post-Operative 
Assessment form. 

 
 
 
                                                                                                                                   
21
2.2.5.7 Final Assessment 
Subjects who have completed 12 months of follow-up will continue annual follow-
up examinations for life with annual reports submitted to the Food and Drug 
Administration for 5 years. These follow-up visits will include a physical 
examination, a CT, and a plain film x-ray as defined in the Chart of Study 
Procedures (Appendix F). Subjects who received a Medtronic/Talent stent-graft 
implant and who choose to discontinue participation in the study prior to study 
completion will be contacted to perform a final assessment prior to study closure. 
The final assessment will be recorded on Post-Operative Assessment and 
Termination CRFs. 
A Termination Case Report Form will be completed for every subject regardless of 
the reason for study termination. A chart may be found in Appendix F indicating the 
times at which procedures and tests will be performed. 
2.2.6 Adverse Events 
Any adverse experiences reported by a subject in the study or noted by the 
Clinical Investigator/Sponsor, will be reported on the Post-Operative Assessment 
CRF (Appendix E). Each experience must be categorized by the Clinical  
Investigator/Sponsor by its degree of severity (mild - the event did not require 
treatment, moderate - the event was treated locally or by minimally invasive 
treatment, or severe - the event was fatal or resulted in permanent injury or 
disability), its relationship to study device and implantation procedure (not related, 

 
 
 
                                                                                                                                                
22
associated with, caused by), and whether or not the adverse experience was 
unanticipated. An unanticipated adverse effect as defined by the FDA is any serious 
adverse effect on the health and safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem or death was not 
previously identified in nature, severity or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety or welfare of subjects (Section 812.3). Refer to Appendix D, Instructions for 
Use, and the Study Subject Informed Consent (Appendix H) for a listing of known 
events. 
 Adverse events are to be scored as follows: 
None; the event was not observed 
                          =Mild; the event was observed, but no treatment was required or the event 
resolved without treatment 
                 =Moderate; the event was treated locally or by minimally invasive means 
                          =Severe/Serious as defined below 
• life-threatening (or fatal). 
• results in permanent impairment of a body function or permanent damage to a 
body structure; or 
• necessitates medical or surgical intervention to preclude permanent impairment 
of body function or permanent damage to a body structure. 

 
 
 
                                                                                                                                   
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The Clinical Investigator/Sponsor will report all unanticipated, device deterioration 
events to the FDA. 
Historical data have demonstrated that several types of complications are known to 
occur with this procedure. These complications are described in the following sections 
 
2.2.6.1 Endoleaks 
Immediately after placement of the Medtronic/Talent Endoluminal Stent- 
Graft, or upon later evaluation, endoleaks may be detected. Endoleaks are 
considered any extravasation of contrast outside of the flow channel established by the 
stent-graft. For purposes of this study, endoleaks that are detected and corrected during 
the implantation procedure are not considered a complication of the Talent device or 
procedure. However, uncorrected endoleaks that develop during implantation or 
endoleaks that develop after implantation are considered complications and must be 
reported on the Procedure or Post-Operative Assessment CRF. The type and possible 
cause of the endoleak should be noted on the CRF.  
Treatment of endoleaks is at the discretion of the Clinical Investigator/Sponsor. In 
general, it is recommended that endoleaks be corrected during the initial procedure 
unless the Clinical Investigator believes that there is a likelihood that the endoleak 
 
 

24 
may spontaneously seal after a few days. The decision to intervene at later 
intervals will be based on the severity of the endoleak, the possible cause of the 
endoleak, the status of the aneurysm, and the subject's general health. Known or 
suspected endoleaks must be monitored carefully postoperatively with 
appropriate diagnostic imaging. 
 Attempts to correct postoperative endoleaks may be done by any of the following 
procedures: 
▪ using an endovascular balloon to remodel the stent-graft 
near the endoleak. 
▪ implanting an extension cuff over the endoleak; or 
▪ surgical intervention. 
           Any procedure performed to correct postoperative endoleaks will be recorded    
on the Post-Operative Assessment CRF. 
       2.2.6.2.   Conversion to Surgery 
In some subjects there may be difficulty inserting the Medtronic/Talent System 
during the procedure. If it is not possible to complete implantation of the device, 
or if peri- or post-operative complications arise that place the subject at risk, the 
Clinical Investigator/Sponsor may elect to convert the patient to open surgery. 
Alternatively, the Clinical Investigator/Sponsor may elect not to repair the TAA, 
and to manage the patient with observation only. In such cases, the reason for 
conversion must be recorded on the Procedure CRF. 

25 
          Also, as noted previously, subjects who convert to surgery or who are managed by 
observation will be followed in an identical manner as the other subjects. A Post-   
Operative Assessment CRF will be completed at 1, 6, and 12 months after the attempted 
implantation. 
 
   2.2.6.3 Death 
 Autopsies will be requested for subjects who expire following 
implantation of       a 
Medtronic/Talent stent-graft. If the patient or the family consents to a post- mortem exam, 
the device will be explanted whenever possible for examination and histological analysis. 
The Clinical Investigator/Sponsor will request that the explanted device be sent to the 
designated facility for examination and histological analysis. The Clinical 
Investigator/Sponsor will determine whether or not the device (or procedure) caused or 
contributed to the subject's death. 
 
2.2.6.4  Other Adverse Events 
     The health risks associated with use of the Medtronic/Talent Endovascular System may 
be less than for conventional surgical treatment. However5 as .with any medical 
procedure, there are some risks. There is the potential for discomfort or complications 
resulting from the procedure and the implanted Stent-Graft. It is hypothesized that the 
rate of serious adverse events in stent-graft patients will be less as compared to an 
expected serious adverse event rate for surgical patients. 
Following is a non-exhaustive list of potential serious complications that may occur during or 
following implantation of a Medtronic/Ta1ent Endoluminal Stent-Graft: 

26 
• distal or proximal embolization that may lead to stroke, amputation, kidney 
failure, multiple organ failure, or death. 
• 
renal insufficiency or failure, that may necessitate dialysis. 
 immediate leaking into the aneurysm, possibly leading to rupture of 
the aneurysm and death; 
• later leaking into the aneurysm, possibly leading to rupture of the aneurysm 
and death. 
• vessel rupture, possibly leading to shock, conversion to surgery, or death. 
• migration of the device, possibly leading to rupture of the aneurysm, open 
surgery, or death. 
• blood loss, possibly leading to shock or death. 
 gaff twisting or kinking, possibly leading to shock or death. 
• infection, possibly leading to septicemia or death.  
• occlusion of blood flow to the spinal cord, possibly leading to temporary or 
permanent paraparesis or paraplegia; 
• conversion to open surgery with all the risks associated with an open 
surgical repair; 

27 
• 
myocardial infarction, arrythmia and/or congestive heart failure possibly leading 
to shock or death. 
 respiratory failure possibly leading to death. 
Similarly, there are a number of minor risks and discomforts that could result from the 
implant procedure or adjunctive tests/analyses. The following is a summary of those 
potential discomforts. 
• Heart and lung testing may involve some discomfort. 
• 
Blood collection may cause bruising and/or discomfort. 
• 
The CT and angiography procedures may cause discomfort during scanning but 
should not cause pain. 
• The radiopaque dyes used during CT and angiography procedures can cause 
nausea, vomiting, or other reactions. 
• Some pain and bruising at the site may result in the groin where the device 
is insertero 
2.2.7 Scientific Soundness and Analysis of Data 
All patients will be treated using the same inclusion/exclusion criteria and are treated under 
the same protocol.  Standard data forms will be used to collect information about all 
procedures and evaluations performed, to provide comprehensive documentation of the study. 
Each patient will be carefully monitored following treatment at specified intervals for 
evaluation of adverse effects and clinical effectiveness of the device. 

28 
     2.3 Risk Analysis 
     2.3.1 Risks to the patient 
Treatment with the Medtronic/Ta1ent Endoluminal Stent-Graft is an invasive 
procedure that poses significant risks to the patient. Patients participating in this 
trial as study patients will be exposed to such risks. These risks include the 
potential for discomf01t or complications resulting from the procedure and the 
implanted stent-graft as described in Section 2.2.6.4. 
 
2.3.2 Manner in which risks will be minimized 
These risks to the subject are minimized by the design of the stent-gaff, using 
materials with a history of vessel repair and a strong kink-resistant self-
expanding, conforming spring that aids in establishing a good seal with the 
vessel wall. Correct sizing of the stent-graft and quick placement with little 
manipulation reduces the risk of adverse events such as embolization, endoleak, 
thrombosis, device migration, or rupture. Adequate modeling of the stent onto 
the vessel wall decreases the chance of leakage or migration of the device. 
Hemostasis valves incorporated into the delivery system help minimize blood 
loss. Risk of infection is minimized by quick placement with little manipulation 
and the use of prophylactic antibiotics. The risk of conversion to open surgery 
is minimized by the design of the delivery and placement system, availability 
of extension pieces, and the ability to move the stent-graft after placement, prior 
to ballooning. 

29 
2.3.3 Justification of the study 
Experience with other stent-grafts and with the Medtronic/Talent Endoluminal Stent-
Graft in thoracic aortic aneurysms has shown-this to be an effective method for 
treatment of aortic aneurysm in patients who meet the anatomic criteria.  
Patients who undergo stent-graft implantation and are found to have inadequate repair of 
the TAA may be treated by conventional surgical repair. Implantation of the Talent 
Stent-Graft requires a much less extensive surgical procedure than conventional surgical 
TAA repair, thus the patients who are enrolled as study subjects are likely to have 
adequate TAA repair with less risk than that associated with the standard technique. 
Patients who receive the Talent Stent-Graft will be followed for life to ensure adequate 
TAA repair. Alterative treatment will be available to any patient in the study group who 
is found to have inadequate TAA repair. 
2.3.4 Patient population 
 
   The patients who will be enrolled in this study will have documented descending thoracic 
aneurysms, dissecting aneurysms, penetrating ulcers, traumatic transections and 
pseudoaneurysms (traumatic or degenerative). People at risk for TAA are predominantly 
elderly (over 65), either male or female, of all ethnic backgrounds. The study will include 
high risk and low risk males and females between 18 and 90 years of age, of any race 
who have been diagnosed with supraceliac lesions of the descending thoracic aorta 
including true aneurysms, dissecting aneurysms, penetrating ulcers, traumatic 
transections or traumatic or degenerative pseudoaneurysms, who are considered to be 
good candidates for endoluminal repair of the aneurysm, and whose vascular anatomy 
fulfills the requirements for Medtronic/Talent Endoluminal Stent-Graft implantation. 

30 
 
        2.4 Device Description 
        The Medtronic/Talent Endoluminal Stent-Graft System is composed of a 
flexible, implantable vascular stent-graft endoluminal device preloaded in a 
delivery system. 
        An illustration of the system may be found in Appendix D, Instructions for Use. 
 
2.4.1 Medtronic/Talent Endoluminal Stent-Graft 
          The Medtronic/Talent endoluminal stent-graft system is a second-generation 
device designed to permit the treatment of a potentially larger number of 
patients by means of a reduction in the diameter of the device's introducer 
delivery system by on average two French sizes. This reduction is achieved 
by using a monofilament graft material that is thinner yet is just as strong and 
in some cases stronger than the first-generation graft material. The reduction 
in French size potentially allows for the treatment of patients with smaller 
diameter and more tortuous and calcified access arteries without sacrificing 
device strength and durability. 
Like the first-generation system, the Medtronic/Ta1ent system is composed of a 
stent-graft end prosthetic device and a placement system. The stent graft is provided 
preloaded within a delivery catheter and introducer sheath. The endoprosthesis is 
inserted via the delivery catheter and  introducer sheath through the femoral or iliac 
artery by surgical cutdown. 

31 
   The implanted endoprosthetic portion of the stent-graft device is composed of a vascular graft 
sewn to a self-expanding nickel-titanium (nitinol) wire stent frame. This is the same stent-
frame material that was used in the first-generation system. Similarly, the vascular graft 
component is a thin woven polyester which is commercially available for surgical 
repair of blood vessels. The first-generation system uses a polyester manufactured by 
Meadox and by Bard. The material used in the  Talent system is a thinner 
(monofilament) polyester material. Polyester fabrics have been used routinely in 
vascular surgery for 50 years. Metallic stents are commonly used to treat peripheral 
vascular disease. The Medtronic/Talent Endoluminal Stent-Graft device used to repair 
TAAs is available in a straight configuration consisting of one or more pieces. 
                      The Stent-Graft for thoracic implantation is a straight tubular design.      Depending on 
the patient's aortic and aneurysm anatomy, the stent-graft may be supplied as a single 
section or a modular multi-section system. Additional sections, referred to as 
extensions, may be added as needed (e.g., if a leak resulting from incomplete exclusion 
of the aneurysm (endoleak) is discovered either during the implantation procedure or 
post procedure). Each section is introduced separately into the vasculature and mated 
in vivo to sections already in situ. All sections are composed of a metal stent coupled 
to a fabric vascular graft. The metal stent frame is made of small diameter nitinol 
monofilament wire with a titanium oxide coating formed into a-series of ring-like zig-
zag springs connected by connecting bars. The stent is sewn with suture to the lumen 
of a proprietary low-permeability polyester material. This material is thinner than the 
Meadox and Bard graft materials used in the first-generation system, but is it is 
chemically-equivalent in its composition. 
The Talent stent-graft system will be custom built for each patient (i.e., patient-specific). 
Anatomical measurements from each patient are used to manufacture a stent-

32 
graft. The stent-graft can vary in diameter, length, end design, and axial cross-
section (cylindrical tube versus tapered tube), as required for each patient's 
anatomy. 
Depending on physician preference and specific anatomical requirements, 
the proximal and distal ends of the Talent stent-graft are available with or 
without coverage with the polyester fabric. In the uncovered version 
(referred to as the bare spring design) there is an additional 1.5 cm length 
(nominal) spring that is uncovered    and is joined to the most proximal or 
distal spring of the stent-graft. The bare spring design is intended to allow 
placement of the most proximal or distal portion of the device across 
involved arteries (e.g., the left subclavian artery) that originate from the 
aorta. The covered version is referred to as the open web design and may 
be used when the device is not intended for placement adjacent to a patent 
vessel.

 
Anatomical measurements from each patient are used to manufacture a Talent 
Stent-Graft. The stent-graft can vary in diameter, length, proximal and distal 
design (open web versus bare spring), and axial cross-section (cylindrical tube 
versus tapered tube), as required for each patient's anatomy. The diameter of the 
stent-graft may range from 20 to 46 mm, in 2 mm increments. The range for stent-
graft length is 70 to 200 mm per section, in 10 mm increments. Due to the required 
2-6 mm diameter oversizing, the diameter of the Stent-Graft will be approximately 
2-6 mm larger than the diameter of the native aorta. Oversizing is required to 
provide for the necessary outward radial force to hold the stent-graft in place against 
the aortic wall. 
         The nitinol spring stent is collapsed for pre-loading over a polyurethane balloon 
delivery catheter and placed into the tip of a Teflon delivery sheath. The spring stent 
self-expands upon exiting the sheath to conform to the shape and size of the aorta. 
Platinum iridium marker bands are sewn onto the most proximal and distal portions 
of the stent-graft to aid in the visualization and accurate placement of the device under 
fluoroscopy. When multiple sections of the main device or extensions are used, the 
marker bands are used to aliB1 the pieces and ensure adequate overlap of the mating 
sections. 
For those cases in which an additional length of stent-graft is needed to extend an 
implanted device, shorter Talent stent-graft sections (extension cuffs); either open 
web or bare spring desiY1s, are available. The open web version is used to seal 
leaks that are not closely adjacent to a patent artery, and the bare spring version is 
used to seal leaks when a patent artery will be crossed. Extension cuffs can be 
manufactured in a straight or a tapering configuration. 

34 
The diameter of an extension cuff can range from 20 nun to 46 mm, in 2 mm 
increments. The range for cuff lengths is 70 to 200 mm per section, in 10 mm 
increments. Depending on the diameter of the target vessel, the extension cuffs 
are oversized by the same 2-6 mm as the main aortic sections. 
 
2.4.2 Medtronic/Talent Placement System 
The systems intended for use in this study will have the improved Talent 
delivery system. Like all Talent systems, the delivery system is composed of 
a catheter and an introducer sheath. A pushrod with a distal plunger is included 
with the delivery catheter to allow deployment of the stent-gaff from the 
introducer. The delivery catheter is equipped with a central balloon, which is 
used after stent-graft deployment to model the stent-graft against the vessel 
wall and to remove any 
in the graft material. The Talent system also 
features several improvements over previous delivery systems: a flexible 
tapered tip, a coil within the introducer to permit smoother navigation through 
vasculature, a stainless steel bullet to reduce sheath kinking, a radiopaque 
sheath marker to improve visualization of the sheath, and a reinforced pushrod 
with ergonomic luer handle for improved handling and control. 
 
2.4.3 Stent-Graft System 
The complete Medtronic/Talent Endoluminal stent-graft system is composed of 
the vascular spring stent-graft and the placement system. During manufacture, 
the stent-graft device is collapsed over the delivery catheter and preloaded into 
the delivery introducer sheath. The spring stent self-expands upon deployment 

35 
from the sheath and conforms to the shape and size of the blood vessel. The stent 
may be balloon-modeled against the aortic vessel wall. 
2.5 Monitoring Procedures 
 
2.5.1 Procedure for Monitoring 
A designated study monitor will periodically inspect relevant study records to ensure 
that the study is being conducted in accordance with FDA regulations, the signed 
Investigator Agreement, and the approved investigational plan. 
2.5.2 Name and Address of Monitor 
The monitor for the study will be Mary Ann Abeline LoBue, RN, CCRN, MA,
Department of Vascular Surgery, Box 11, Harbor UCLA Medical Center, 1000 
W. Carson Street, Torrance, CA 90502. 
 2.6 Bibliography 
Coselli JS, S Buket, and ES Crawford. 1996. Thoracic aortic aneurysms. In: 
Haimovici Vascular Surgery, 4th ed, H Haimovici, E Ascer, 111 Hollier, DE 
Strandness, and JB Towne, eds. Blackwell Science, chapter 57. 
Coselli JS and SA LeMaire. 1995. Diseases of the thoracic aorta. In: Current 
Diagnosis and Treatment in Vascular Surgery, 1st ed, RH Dean, JST Yao, and DC 
Brewster, eds. Appleton & Lange, Norwalk, CT, chapter 11. 

36 
Dake ND, DC Miller, CP Semba, et al. 1994. Transluminal placement 
of endovascular stent-grafts for the treatment of descending thoracic 
aortic aneurysms. New Eng JMed, 331: 1729-1734. 
Mitchell RS, DC Miller and Dake. 1997. Stent-y-aft repair of thoracic aortic 
aneurysms. Seminars in Vascular Surgery, 10:257-271. 
 
Moreno-Cabral 
 1984. Degenerative and 
atherosclerotic aneurysms of the thoracic aorta: determination of early and late 
surgical outcome. J Thoracic Cardiovasc Surg, 88: 1020-1032. 
NajafiH. 1994. Thoracic aortic aneurysm: evaluation and surgical 
management. Comprehensive Therapy, 20:282-288. 
PresslerV and JJMcNamara. 1980. Thoracic aortic aneurysm: natural history 
and treatment. J Thorac Cardiovasc Surg, 79:489-498.  
 
Skeens JL and ND Dake. 1997. Thoracic aortic aneurysm stent-grafts. Eighth 
Complex Peripheral Angioplasty Course. Paris, May 20-235, 1997, pp. 289-
295. 
Nienaber, CA et. al. 1999. Nonsurgical reconstruction of thoracic aortic 
dissection by stent-graft placement. New England Journal of Medicine, 340 
(20): 1539-1545. 
White RA, Donayre CE, Walot I, et. al. 2001. Endovascular exclusion of 
descending thoracic aortic aneurysm and chronic dissections: Initial 

37 
clinical results with the Aneurx device. Journal of Vascular Surgery, 33 
(5): 927-934. 
3. Manufacturing Information 
 Please refer to the letter from Medtronic, Inc. dated December 19, 2001  
  (Attachment A) granting the investigator permission to reference Medtronic's IDE 
# G980116 for information on manufacturing, processing, packing, storage, and 
installation of the Medtronic/Talent Endoluminal Stent-Graft. 
 4. Investigator Information 
Please refer to Attachment G for a sample Investigator agreement and the 
Investigators' curriculum vitae. The investigators are not involved in an investigation 
or other research that was terminated. The investigators are committed to conduct the 
investigation in accordance with the agreement, the investigational plan, Part 812, 
and other applicable FDA regulations, and the conditions of approval imposed by the 
reviewing IRB and FDA. They are also committed to supervise the testing of the 
device involving human subjects and in ensuring that the requirements for obtaining 
the informed consent are met. 
All the participating investigators have signed the agreement and no investigator will 
be added until the agreement is signed. 

38 
 4.1 Name and address of investigators:  
 
        Rodney A. White, MD 
Professor 
of 
Surgery 
Chief, Vascular Surgery 
Harbor-UCLA Medical Center Box 11 
1000 West Carson Street 
Torrance, CA 90509 
Carlos E. Donayre,
 
Associate Professor of Surgery 
Harbor-UCLA Medical Center Box 11 
1000 West Carson Street 
Torrance, CA 90509 
 
Irwin Walot,
 
Chief, Vascular/Interventional Radiology 
Harbor-UCLA Medical Center Box 27 
!000 West Carson Street 
Torrance, CA 9050 
 

39 
5. IRB Information 
Harbor-UCLA Medical Center Research and Education Institute has 2 IRBs: 
1. John F. Wolf Human Subjects Committee (1) 
Jeffrey Phillips, MD, IRB Chair 
Harbor-UCLA Research and Education Institute 
1124 West Carson Street 
Torrance, CA 90502 
2. Human Subjects Committee (2) 
 
            Jeffrey Phillips, MD, Chair 
Harbor-UCLA Research and Education Institute  
1124 West Carson Street 
Torrance, CA 90502 
1 (one) committee will review and approve the investigation. 
 

40 
     6. Sales Information 
 
The devices will be sold at $ 1661.66 according to the agreement with 
Medtronic/World to cover the cost of production of the devices. 
The sale of devices does not constitute commercialization because it only covers      
the cost of device production. 
 
       7. Labeling 
       Please refer to the December 19, 2001, letter from Medtronic, Inc. (Attachment 
A) granting the investigator permission to reference Medtronic's DE # G980116 
for all labeling information. Labeling shall contain the statement "CAUTION — 
     Investigational Device. Limited by Federal (or United States) Law to      
       Investigational Use." 
 
   8. Informed Consent Materials 
     Please refer to Attachment G for a sample of the informed consents.