Exhibit J

Case 2:15-md-02641-DGC Document 8230-4 Filed 10/18/17 Page 1 of 6
Technical Success and Safety of Retrieval of the

G2 Filter in a Prospective, Multicenter Study

Christoph A. Binkert, MD, MBA, Alain T. Drooz, MD, James G. Caridi, MD, Mark J. Sands, MD,

Haraldur Bjarnason, MD, Frank C. Lynch, MD, William S. Rilling, MD, Domenic A. Zambuto, MD,

S. William Stavropoulos, MD, Anthony C. Venbrux, MD, and John A. Kaufman, MD

PURPOSE: To assess the technical success and safety for retrieval of the G2 filter.

MATERIALS AND METHODS: The authors performed a prospective, multicenter study of 100 patients with

temporary indication for caval interruption. Patients were enrolled consecutively between December 2005 and July

2006. There were 67 men and 33 women with a mean age of 52.1 years (range, 19 – 82 years). Indications for filter

placement were trauma (n  56), perioperative risk (n  16), and medical indications (n  28). Forty-two patients had

venous thromboembolism at filter placement. Fifty-eight filters were placed prophylactically.

RESULTS: Retrieval was attempted in 61 patients. Fifty-eight of the 61 filters (95%) were successfully retrieved after a mean

dwell time of 140 days (range, 5–300 days). In all failed retrievals, the filter tip was against the caval wall. There was no

difference in dwell times between successful and unsuccessful retrievals. Although there were no cases of cranial

migration, caudal migrations were observed in 12% of cases (10 of 85 patients with a complete data set). Other device-related

complications included filter fracture (1/85, 1.2%), filter tilt of more than 15° (15/85, 18%), and leg penetration (16/61, 26%).

The recurrent pulmonary embolism (PE) rate was 2%, with no PE in the 30-day period after filter retrieval.

CONCLUSIONS: Retrieval of the Recovery G2 filter was safe and successful in most patients. Caudal migration was

observed as an unexpected phenomenon.

J Vasc Interv Radiol 2009; 20:1449 –1453

Abbreviations: DVT  deep venous thrombosis, IVC  inferior vena cava, PE  pulmonary embolism, VTE  venous thromboembolism

VENOUS thromboembolism (VTE) is

a leading cause of death in hospitalized patients (1–3). Anticoagulation is

the standard therapy for VTE, but in

certain cases anticoagulation may be

contraindicated for short- or long-term

VTE therapy.

Inferior vena cava (IVC) filters have

been shown to successfully prevent

pulmonary embolism (PE) (4). However, although IVC filters decrease the

risk of PE in the short term, they are

associated with a higher incidence of

deep vein thrombosis (DVT) after 2 and

8 years (5,6). The observation of Decousus et al (5) stimulated the idea of optional filters. Optional filters are permanent filters with the “option” to be

retrieved if they are no longer clinically

needed to avoid possible long-term adverse effects of permanent filters.

The G2 filter (Bard Peripheral Vascular, Tempe, Arizona) is a secondgeneration optional filter with an updated design compared to the original

Recovery filter (Bard Peripheral Vascular). The permanent use of the G2

filter for the prevention of PE was previously reported (7–10). The purpose

of this study was to assess the retrievability of the G2 filter.

MATERIALS AND METHODS

Study Design

This prospective single-arm multicenter Investigational Device Exemption clinical study, sponsored by Bard

Peripheral, was conducted in accorFrom the Department of Radiology, Brigham and

Women’s Hospital/Harvard Medical School, Boston, Massachusetts (C.A.B.); Department of Radiology, Inova Fairfax Hospital, Falls Church, Virginia

(A.T.D.); Department of Radiology, University of

Florida, Gainesville, Florida (J.G.C.); Department of

Radiology, Cleveland Clinic, Cleveland, Ohio

(M.J.S.); Department of Radiology, Mayo Clinic,

Rochester, Minnesota (H.B.); Department of Radiology, Penn State Milton S. Hershey, Hershey, Pennsylvania (F.C.L.); Department of Radiology, Froedtert Memorial Lutheran Hospital, Milwaukee,

Wisconsin (W.S.R.); Department of Radiology, Hartford Hospital, Hartford, Connecticut (D.A.Z.); Department of Radiology, Hospital of the University of

Pennsylvania, Philadelphia, Pennsylvania (S.W.S.);

Department of Radiology, George Washington University Medical Center, Washington, DC (A.C.V.);

and Department of Radiology, Dotter Interventional

Institute, Portland, Oregon (J.A.K.). Received February 12, 2009; final revision received August 9, 2009;

accepted August 13, 2009. Address correspondence

to C.A.B., Institute of Radiology, Kantonsspital Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland; E-mail: christoph.binkert@ksw.ch

From the 2008 SIR Annual Meeting.

The study was an industry-funded clinical research

by Bard Peripheral, Tempe, Arizona. A.T.D. is a

lecturer with honorarium at Bard Peripheral, F.C.L.

is a paid consultant for Bard, and S.W.S. has a research grant from and is a consultant to BARD Peripheral. None of the other authors have identified a

conflict of interest.

© SIR, 2009

DOI: 10.1016/j.jvir.2009.08.007

1449

Case 2:15-md-02641-DGC Document 8230-4 Filed 10/18/17 Page 2 of 6
dance with the SIR reporting standards

(11) at 11 sites within the United States:

Brigham & Women’s Hospital, Boston,

Massachusetts; Inova Fairfax Hospital,

Falls Church, Virginia; University of

Florida, Gainesville, Florida; Dotter Interventional Institute-OHSU, Portland,

Oregon; Cleveland Clinic, Cleveland,

Ohio; Mayo Clinic, Rochester, Minnesota; Penn State, Hershey, Pennsylvania;

Hartford Hospital, Hartford, Connecticut; Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin; Hospital

of the University of Pennsylvania, Philadelphia, Pennsylvania; and George

Washington University Medical Center,

Washington, DC.

Patients were consecutively enrolled

from December 2005 through July 2006.

All patients were informed of the risks

and benefits of participating in the

study and gave written informed consent to participate before enrollment.

The protocol was approved by the institutional review board at each study site,

and all study procedures were conducted in accordance with Good Clinical Practices.

Study procedures included ultrasonographic (US) screening for a patent

jugular vein to be used for future filter

retrieval, placement of the study filter,

and conventional radiographic examination of the abdomen in full expiration

(anteroposterior, lateral, and bilateral

anterior-oblique projections) within 48

hours after filter placement. If the filter

was not retrieved, a phone assessment

was conducted at 3 months and a clinic

visit at 6 months, including repeat conventional radiography.

The indication for filter retrieval was

discussed with the referring medical

team. Filter retrieval was performed if

there was no longer an increased risk for

PE and/or no longer a contraindication

to anticoagulation. Vascular US of the

deep vein system was performed beforehand in patients with prophylactic

filter placement. If no DVT was found,

no further anticoagulation was undertaken. If a DVT was found in these patients and in all patients with known

DVT or PE, a 6-month course of anticoagulation was carried out. A cavogram

with iodinated contrast medium was

obtained before and after filter retrieval

in all patients. In addition, a follow-up

clinic visit was required 1 month after

retrieval.

Patient Population

One hundred patients (67 men, 33

women) were included in the study.

The mean patient age was 52.1 years

(range, 19 – 82 years). Patients considered for inclusion in the study were

temporarily at increased risk for PE

with a need for caval interruption because of a contraindication of anticoagulation. The indication for filter

placement is summarized in the Table.

Additional study requirements included an estimated life expectancy of

more than 6 months, a normal rightsided IVC with a diameter less than 28

mm, and a serum creatinine level of

less than 2.0 mg/dL (176.8 mol/L)

for safe application of iodinated contrast medium.

Forty-two patients presented with

VTE at filter placement: 18 had DVT

only, 10 had PE only, and 14 had both

DVT and PE. Of the 58 patients without VTE, 10 had a history (3 months)

of VTE.

Device

The devices used in this study were

the G2 filter (Figure) and the Recovery

Cone Removal System (Bard Peripheral

Vascular). The filter consists of 12 shapememory nitinol wires emanating from a

central nitinol sleeve. The wires form

two levels of filtration, with the legs (leg

span, 40 mm; overall height, 39 mm)

providing the lower level of filtration

and the arms (arm length, 18.5 mm;

span, 33 mm) providing the upper level

of filtration. The nitinol filter was designed for use in IVCs with diameters

less than or equal to 28 mm. The insertion and retrieval techniques were previously described by Oliva et al (12).

Outcome

The primary objective of the study

was to assess the technical and clinical

success of the G2 filter retrieval, including adverse events within 30 days

after retrieval. In addition, we evaluated the overall clinical experience, as

assessed by filter migration and filter

fracture and relevant placement procedural parameters and outcomes.

Filter migration was defined as a

change in filter position compared to its

deployed position (either cranial or caudal) of more than 2 cm as documented

with plain radiography or venography.

Filter fracture was defined as any loss of

structural integrity (ie, breakage or separation) of the filter documented at imaging. Filter penetration/protrusion

was defined as penetration of a filter leg

or arm of more than 3 mm outside the

IVC measured at venography according

to the American College of Radiology

Practice Guidelines (13). During the

clinical visit 6 months after filter placement or 1 month after filter retrieval, a

history and physical examination was

performed, focusing on symptoms of PE

(shortness of breath) and DVT (leg

swelling, leg pain).

RESULTS

Filter Placement

All 100 G2 filters were deployed

successfully. For access, the right common femoral vein was used 90 times,

and the left common femoral vein was

accessed 10 times.

The mean fluoroscopy time was 3.2

minutes (range, 0.4 –33.6 minutes). The

mean IVC diameter ( standard deviation) was 20.5 mm  3.4 (range,

12–28 mm). Two filters were noted to

Indications for Filter Placement

Indication for Filter

Placement

No. of

Patients

(n  100)

Trauma* 56 (56%)

Surgery (within 1 mo)† 16 (16%)

Nonsurgical treatment‡ 28 (28%)

* The trauma category includes spine,

abdominal, long bone, pelvic, thoracic,

and head trauma.

† The surgical category includes

surgical patients with a history of or

active VTE at the time of filter

placement, including those with a

primary diagnosis that was bariatric,

gastrointestinal, orthopedic (joint

replacement, spine), neurosurgical

(intracranial, spine), or related to a

gynecologic procedure.

‡ The nonsurgical treatment category

includes patients with a medical

condition preventing safe

anticoagulation, including those with a

primary diagnosis that was related to

cancer (with or without metastases), a

gynecologic disorder,

hypercoagulopathy (without

malignancy), morbid obesity, or stroke

(within 6 months).

1450 • Technical Success and Safety of Retrieval of the G2 Filter November 2009 JVIR

Case 2:15-md-02641-DGC Document 8230-4 Filed 10/18/17 Page 3 of 6
have had a tilt of more than 15° immediately following placement. Both filters were placed from the right common femoral vein, and no attempt was

made to straighten the filters. All imaging studies were assessed by the site

investigators.

Postplacement Procedure Follow-up

All patients enrolled in the study

were to be followed up to 6 months after

filter placement or to 1 month after filter

retrieval, whichever came first. A phone

call was placed 3 months after filter

placement to assess filter retrieval status, current medications, and adverse

events. Office visits were scheduled at 6

months after placement if the filter had

not been retrieved. A physical examination, current medication assessment, adverse event assessment, and follow-up

imaging were completed (supine anteroposterior abdominal radiography in

anteroposterior and lateral projections

at full expiration and posteroanterior

digital spot radiography centered on the

filter). If the physician determined that

the filter continued to be clinically indicated, the device could be left in place

permanently. At study completion,

83 of the 100 patients enrolled had a

complete data set for evaluation (see

Final Follow-up).

Filter Retrieval

Retrieval was attempted in 61 patients. The right internal jugular vein

was used for access in all cases. In 58

of the 61 patients, retrieval was successful. All study retrieval procedures

were performed by using standard Recovery cone technique. In three cases,

retrieval failed because the filter tip

could not be engaged with the cone as

the filter tip was embedded in the IVC

wall.

The mean fluoroscopy time for the

attempted filter retrievals,, as recorded

in 59 of the 61 patients, was 7.4 minutes  10.5 (range, 1.4 –59.8 minutes).

The mean fluoroscopy time for successful retrieval procedures (56/58 recorded values) was 6.3 minutes  8.5

(range, 1.4 –59.63 minutes). The mean

fluoroscopy time of unsuccessful retrieval attempts was 27.8 minutes

(range, 2.4 – 48.3 minutes). The significantly longer fluoroscopy times for the

unsuccessful retrievals are indicative

of more difficulties during retrieval attempt (P .03).

The mean filter dwell time in the 61

patients in whom retrieval was attempted was 138 days (range, 5–300

days). The mean dwell time in patients

with successfully retrieved filters was

140 days (range, 5–300 days). The

mean dwell time in patients with

failed retrievals was 107 days (range,

92–134 days). There was no statistically significant difference between

the dwell times of successful versus

unsuccessful retrievals (P  .11).

Venography was normal in 52 of

the 61 attempted retrievals (in one

case, venograms were lost). In eight

cases, venograms were reported as abnormal. Four venograms showed a

small thrombus in the filter. In three

cases, a stenosis was noted at the filter

level of the IVC before retrieval and in

two cases there was a stenosis after

retrieval secondary to difficulties during filter retrieval. One stenosis was

measured at more than 50%; however,

there were no related clinical sequelae

noted at the 1-month follow-up visit.

In one case, both a stenosis of the IVC

and a thrombus in the filter was documented.

Final Follow-up

Overall, 83 of 100 patients had a complete data set either with successful retrieval or observation for 6 months. Four

patients completed all clinical evaluations but were lacking final imaging. Fiftyeight of the 61 attempted filter retrievals

were successful. As previously discussed, three filter retrieval attempts

were unsuccessful. Fifty-six of the 58 patients completed 1-month follow-up after retrieval; two patients were lost to

follow-up. A total of 42 filters were not

retrieved. No retrieval attempt was undertaken in 39 patients. Thirty-one of

the 42 patients in whom filters were not

retrieved completed the 6-month follow-up. However, as mentioned above,

the final imaging data set was not available in four patients. Of the 11 patients

who did not complete follow-up, six

died, three withdrew consent, and two

were lost to follow-up as previously discussed. Six deaths were reported between 22 and 100 days after filter placement (mean, 60.6 days). All were due to

Figure. G2 filter. Compared with the original Recovery filter, the arms are longer and

the legs wider. The welding at the tip was also changed.

Volume 20 Number 11 Binkert et al • 1451

Case 2:15-md-02641-DGC Document 8230-4 Filed 10/18/17 Page 4 of 6
pre-existing conditions (colon cancer,

cardiac arrest, myocardial infarction,

chronic obstructive pulmonary disease,

pneumonia, and chondrosarcoma) and

were not related to the study device,

placement procedure, or retrieval procedure.

During the study, two symptomatic

PE were recorded. Both PE occurred

with the filter in place. No PE was

noted during the 1-month observation

period after the filter was removed.

No new symptomatic DVT was noted

during the study period.

Procedure-related Complications

One hundred filters were successfully deployed in 100 patients. There

were four procedure-related complications during the study: three complications occurred during placement and

one complication occurred during retrieval. One patient experienced an allergic skin reaction following access site

preparation during both implantation

and retrieval. One patient had acute renal failure secondary to multiple, sameday contrast studies and one had a hematoma related to device placement;

however, all complications were resolved with no clinical sequelae.

Device-related Complications

Migration.––Ten filter migrations of

more than 2 cm occurred in the 85 patients (12%) who were assessed for this

category at a mean follow-up of 155

days (range, 5–323 days). The mean migration distance observed for the 10 migrated filters was 2.7 cm (range, 2.0 –

4.1cm). The 85 filter images analyzed for

this endpoint include 58 filters imaged

at retrieval and 27 nonretrieved filters

imaged at 6 months. All migrations occurred toward the feet (ie, caudal migration). Five of these migrated filters were

retrieved successfully and two remained in place after an unsuccessful

retrieval attempt. In three cases, no retrieval attempt was performed.

Filter fracture.––One filter fracture

occurred in the 85 assessed devices

(1.2%). Preretrieval venography performed on day 92 revealed a mild filter tilt with a fractured strut external

to the IVC. One arm and one leg were

observed outside the IVC. A retrieval

attempt was unsuccessful secondary

to the apex being embedded in the

IVC wall. Nevertheless, this patient remained asymptomatic and without

symptoms of PE during final follow-up through day 209.

Filter tilt.––Overall, 15 of the 85 filters

(18%) with assessable images showed a

tilt of more than 15°. Two previously

mentioned filters tilted during placement; the remaining 13 developed tilt

during follow-up. Of the 15 tilted filters,

10 were removed successfully and three

could not be removed. In two cases, no

retrieval attempt was performed. No PE

or other adverse event occurred in this

group.

Filter penetration.––Assessment of filter penetration was only possible in the

61 patients who underwent venography

before filter retrieval. Sixteen of the 61

patients (26%) showed a filter leg or arm

penetrated more than 3 mm outside the

IVC. Of these 16 patients, 14 had undergone a successful retrieval. Fifteen of 16

patients with penetration were asymptomatic, and one patient reported back

pain that was relieved following filter

retrieval.

Complication relationship.––The study

data show a significant relationship between tilt or more than 15° and migration (P  .001); however, there is no

statistical evidence that either migration

or tilt is related to penetration.

DISCUSSION

In the present study, a relatively

high percentage of retrieval attempts

were undertaken (61/100). This is similar to that performed in other trials––

including the studies by Ray et al (14)

(47.7%), Keller et al (15) (49%, 70%),

and Wicky et al (16) (67%)––and substantially higher than the retrieval rate

in a clinical setup reported by Grande

et al (17) (14%). This observation underlines again the importance of an

organized follow-up in patients with

optional filters.

The retrieval success of the G2 filter

in our multicenter study was good, with

a technical success rate of 95% (58/61).

In a single-center study, Oliva et al (12)

had an even higher retrieval rate

(100%) for the G2 filter. The retrieval

rates for the G2 are similar to those

reported for other filter types: The

rates for the Gu ̈ nther Tulip filter, the

original Recovery filter, the ALN filter

(ALN Implants, Chirurgicaux, Ghisonaccia, France), and the OptEase filter (Cordis, Bridgewater, New Jersey)

varied from 76% to 98%; 82% to 100%,

50% to 100%, and 91% to 100%, respectively (14,15,17–20). The fluoroscopy

times for filter retrieval (mean, 7.4

minutes; range, 1.4 –59.8 minutes)

were similar to those of other reports

with the Gu ̈ nther Tulip filter (Wicky et

al [16] reported a mean fluoroscopy

time of 6.61 minutes and de Gregorio

et al [21] reported a mean fluoroscopy

time of 4.4 minutes) and the original

Recovery filter (Binkert et al [9] reported a mean fluoroscopy time of 5.8

minutes).

The retrieval rates may have been

even higher had alternative retrieval

techniques, such as the loop-snaretechnique, been applied (22). However,

during the present study only the standard retrieval with the Recovery cone

was allowed. Retrieval failures were all

due to tilted filters with the tips embedded in the IVC wall and were unrelated

to dwell time. The mean dwell time in

our study was 140 days, which is higher

than that reported in most published

studies of other filter types––with reported dwell times between 8 and 28

days (15,16,23). The results from the

present study suggest that the G2 may

likely be retrievable even after 6 months,

similar to the reported results with the

original Recovery filter (9).

Filter migration is likely the most

concerning filter-related complication.

Cranial migration was not seen with the

G2 filter in our study. Two case reports

described migration of a G2 into the

right ventricle (24,25). In both case reports the G2 did not open properly and

legs entangled within each other, allowing the filter to migrate cranially. It

seems that it is important to check for

appropriate leg opening of the G2 after

placement. Caudal migration, however,

was observed in 10 cases in our study

(12%). This is a rare phenomenon with a

yet unclear mechanism. There is one letter reporting a caudal migration of a G2

filter during carbon dioxide venography

(26). The authors hypothesized that caudal filter displacement was due to rapid

IVC diameter expansion caudal to the

filter caused by carbon dioxide injection.

No carbon dioxide was used in the

present study, but it is possible that

other abrupt changes of the IVC diameter led to caudal migration. The mechanism of caudal migration remains unclear and warrants further investigation.

However, the caudal migration of the

G2 did not cause any clinical problems

in our study.

1452 • Technical Success and Safety of Retrieval of the G2 Filter November 2009 JVIR

Case 2:15-md-02641-DGC Document 8230-4 Filed 10/18/17 Page 5 of 6
The frequency of filter fracture and

penetration has been reduced compared

to original Recovery filter. In our study

only one filter fracture (1.2%) was observed. Another study with the G2 reported no fracture (0/51) (12). These

rates compare favorably with the reported fracture rate of 7.5% for the original Recovery filter (19). The penetration

rate for a filter leg outside the IVC was

also reduced––from the reported 62%

for the original Recovery filter (19) to

26.2% in our study and to 18% of another study looking at the G2 (12).

The Recovery G2 filter provided a

protection against PE in our study. We

encountered two PE (2%), which is

well within the 5% threshold of the

American College of Radiology guidelines and comparable with reported

rates of other studies (Grande et al

[17%], 2.8%; Ray et al [14], 5%; Keller

et al [15], 1.2%; Mismetti et al [18],

2.4%; and Neuerburg et al [27], 2.5%).

Importantly, there was no additional

PE during the 30-day follow-up after

filter retrieval and no new symptomatic DVT caused by the study filter.

The present study has some limitations. The focus was on the technical aspect of the G2 filter. Inclusion criteria to

enter the study were quite open, which

explains the heterogeneous patient population. Clinical follow-up was performed

6 months after placement and/or 1 month

after retrieval. However, during these visits the focus was on detecting clinically

significant DVT and/or PE. The venous

system was not examined with US for

patency or insufficiency. Imaging was

performed according to a defined schedule and technique but without a core laboratory for interpretation.

In conclusion, the Recovery G2 filter

shows filtration properties that meet the

SIR guidelines (28) and which are comparable to other filters. Retrievals were possible after dwell times up to 300 days,

similar to the original reported long dwell

times of the original Recovery filter. Compared to the original Recovery filter, the

new design of the G2 filter showed a decrease in filter fracture and penetration

rates. With the adjusted design, cranial

migration was successfully avoided in the

present study; however, caudal migration

of the filter was observed in 12% of cases.

The mechanism and the clinical effect of

caudal migration warrant further investigation.

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