Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD
Phase: NA
Conditions: PAD
Sponsor: Eximo Medical Ltd.

Safety and Effectiveness Evaluation of Eximo 
Medical’s B-Laser™ atherectomy Device, in Subjects 
Affected with Infrainguinal PAD 
Date:   
02 Oct 2017 
PRODUCT: Eximo Medical B-LaserTM  for PAD 
Page 1 of 5 
Document number: EX-PAD-03 
Revision: 02 
 
Protocol Number 
EX-PAD-03 
Title 
Safety and Effectiveness Evaluation of Eximo Medical’s B-LaserTM, an 
Atherectomy Device, in Subjects Affected with Infrainguinal PAD 
Objective(s) 
The primary objective of the study is to assess the safety and efficacy of the 
Eximo Medical’s B-LaserTM catheter in subjects with infrainguinal peripheral 
artery disease (PAD) 
Study Design 
This is a prospective, single-arm, multi-center, open-label study. 
Inclusion Criteria 
1. Subject is ≥ 18 years old. 
2. Subject is a candidate for atherectomy for infrainguinal peripheral 
artery disease.  
3. Documented symptomatic atherosclerotic peripheral artery disease 
Rutherford Classification 2-4.  
4. Subject has an infrainguinal target lesion(s) with any type of stenosis 
(naïve recurrent, or in-stent) estimated to be ≥70% based on CT 
angiogram or any other imaging modality. 
5. Subject is capable and willing to comply with the scheduled follow up 
6. Subject or appropriate legal surrogate is able and willing to sign a 
written Informed Consent Form (ICF). 
 
Intraoperative inclusion criteria (by fluoroscopy angiogram):  
1. Target lesion has a stenosis estimated to be ≥70%. 
2. In ATK subjects - at least one patent tibial run-off vessel into the foot 
Exclusion Criteria 
1. Target lesion is in a vessel graft or synthetic graft. 
2. Target lesion length <1cm and >15 cm (in ISR cases could be >25cm). 
3. Endovascular or surgical procedure in the target limb performed less 
than or equal to 30 days prior to the index procedure OR Planned 
endovascular or surgical procedure 30 days after the index procedure. 
4. Intent to use other atherectomy device in the same procedure. 
5. Evidence or history of intracranial or gastrointestinal bleeding, 
intracranial aneurysm, myocardial infarction or stroke within the past 2 
months. 
6. Evidence or history of aneurysm in the target vessel within the past 2 
months.  
7. History of bleeding diathesis, coagulopathy or inability to accept blood 
transfusions. 
8. History of heparin-induced thrombocytopenia (HIT) or inability to 
tolerate antiplatelet medication(s), anticoagulation, or thrombolytic 
therapy.  
9. Subjects requiring dialysis. 
10. Known allergy to contrast agents or medications used to perform 
endovascular intervention that cannot be adequately pre-treated. 
11. Serious illness that may affect subject compliance to protocol and 30-
day follow-up. 
12. Participating in another clinical study  
13. Subject is pregnant or planning to become pregnant during the study 

Safety and Effectiveness Evaluation of Eximo 
Medical’s B-Laser™ atherectomy Device, in Subjects 
Affected with Infrainguinal PAD 
Date:   
02 Oct 2017 
PRODUCT: Eximo Medical B-LaserTM  for PAD 
Page 2 of 5 
Document number: EX-PAD-03 
Revision: 02 
 
period. 
14. Life expectancy < 12 months 
15. Any planned amputation above the ankle.  
 
 
Intraoperative exclusion criteria (by fluoroscopy angiogram): 
1. Inability to intraluminally cross and secure a 0.014” wire across the 
target lesion. 
2. Target lesion length <1cm and >15 cm (in ISR cases >25cm). 
3. Reference vessel lumen diameter proximal to target lesion is <150% of 
the outer diameter of the B-LaserTM. 
4. Any clinical and/or angiographic complication prior to the planed 
insertion of B-laser™. 
Primary Effectiveness 
Endpoint 
Acute technical success:  
Reduction from baseline in residual diameter stenosis (measured in 
percent), prior to any adjunctive therapy, achieved by the B-Laser™ catheter, 
as assessed quantitatively by the core laboratory based upon the procedure 
angiograms. This study's primary endpoint will be met if the mean reduction 
in residual diameter stenosis is greater than 20%, prior to any adjunctive 
therapy. 
Primary Safety Endpoint 
Freedom from the following Major Adverse Events (MAEs) through a 30-day 
follow-up period, as adjudicated by the Clinical Event Committee (CEC): 
Unplanned target limb amputation above the ankle 
Clinically Driven Target Lesion Revascularization (CD-TLR) 
Cardiovascular related deaths 
This endpoint will be met if the freedom from MAE rate is greater than 85% 
Secondary Safety 
Endpoints 
Freedom from the following Clinically Significant Device Related Adverse 
Events requiring intervention in the target vessel, as adjudicated by the CEC 
for up to 30 days: 
 
Perforation 
 
Dissection 
 
Distal embolization or in situ thrombus 
 
Pseudoaneurysm 
 
Freedom from non-Clinically Significant Device Related Adverse Events in the 
target vessel, as adjudicated by the CEC for up to 30 days: 
 
Perforation 
 
Dissection 
 
Distal embolization or in situ thrombus 
 
Pseudoaneurysm 
Secondary Effectiveness 
Endpoints 
Percent of subjects with residual stenosis by angiography of ≤ 30% post-
procedure including any adjunctive therapy, with no flow limiting dissection, 
as adjudicated by the core laboratory.   

Safety and Effectiveness Evaluation of Eximo 
Medical’s B-Laser™ atherectomy Device, in Subjects 
Affected with Infrainguinal PAD 
Date:   
02 Oct 2017 
PRODUCT: Eximo Medical B-LaserTM  for PAD 
Page 3 of 5 
Document number: EX-PAD-03 
Revision: 02 
 
PAD measurements at the 30-day visit post-procedure compared to 
baseline: 
 
Ankle-Brachial Index (ABI) 
 
Rutherford Classification 
 
Walking Impairment Questionnaire (WIQ) 
Clinical success at 30 days defined as < 50% stenosis at the treated lesion, as 
assessed quantitatively by duplex ultrasound by the core laboratory when 
the peak systolic velocity ratio is < 2.5. 1   
Statistical Methodology 
 
Primary Effectiveness  
The primary effectiveness endpoint is the reduction from baseline in residual 
diameter stenosis (measured in percent), prior to any adjunctive therapy, 
achieved by the B-LaserTM catheter, as assessed quantitatively by the core 
laboratory based upon the procedure angiograms.  This study’s primary 
effectiveness endpoint will be met if the mean reduction in residual 
diameter stenosis is greater than 20%, prior to any adjunctive therapy. 
   Statistical Hypothesis 
 The primary effectiveness hypothesis to be tested is: 
H0: µDS ≤ 20% vs.  H1: µDS > 20% 
where µDS is the mean reduction from baseline in residual diameter stenosis.   
   Statistical Test 
The hypothesis will be tested using Analysis of Covariance (ANCOVA)  
   Minimum Sample Size 
97 treated subjects (assuming one lesion per subject) 
Primary Safety 
The primary safety endpoint is the percent of subjects free of MAEs 
throughout the 30-day follow-up period, as adjudicated by the CEC.   
   Statistical Hypothesis 
The primary safety hypothesis to be tested is: 
 
 
H0: πMAEF ≤ 85% vs.  H1: πMAEF > 85% 
where πMAEF is the proportion of subjects free of MAEs throughout the 30-
day follow-up period.                     
   Statistical Test 
The hypothesis will be tested via the lower limit of a one-sided exact 
binomial confidence interval. 
Study Population 
The trial population will consist of male and female subjects eighteen (18) 
years of age or older, with symptomatic infrainguinal PAD, scheduled for 
endovascular intervention.  Subjects must also meet all other inclusion 
criteria and not meet any of the exclusion criteria described in Sections 5.3.1 
and 5.3.2 of the Study Protocol.   
                                                          
1 Per FDA request, PSVR will be presented for any subject that underwent DUS. Yet, in cases when a reference PSV is unreliable, an 
asterisk will be added, and the meaning of this asterisk is that true PSVR could not be calculated by the core lab and rather the core is 
presenting a PSVR that is using the best PSV that could be taken. The company will keep in house the records of the alternative 
determination of patency by the core lab in such cases that are based on correlating factors that will be used to determine stenosis 
(further information can be found in section 3.1 of the study protocol, PAD diagnosis, Duplex ultrasonography (DUS)). 

Safety and Effectiveness Evaluation of Eximo 
Medical’s B-Laser™ atherectomy Device, in Subjects 
Affected with Infrainguinal PAD 
Date:   
02 Oct 2017 
PRODUCT: Eximo Medical B-LaserTM  for PAD 
Page 4 of 5 
Document number: EX-PAD-03 
Revision: 02 
 
6-Month Outcomes 
Analysis 
(from Day 36 to the end 
of study) 
The follow-up duration for each subject is 30-days post procedure for the 
primary and secondary endpoints, however subjects will be followed for 6-
months post procedure. 
At follow up visits the following parameters will be collected and recorded: 
 
6-Month Patency (per Lesion): Duplex Ultrasonography for core lab 
assessment of PSVR< 2.5. 
 
 
6-Month Clinical Presentation (per Subject): Clinical performance by 
Rutherford Class, ABI and WIQ  
 
6-Month Site-Reported Adverse Events & Serious Adverse Events 
 
6-Month CEC-Adjudicated Adverse Events 
 
 
6-Month Protocol Deviations 
All parameters measured after the 30-day follow-up (from Day 36 after 
procedure) will be summarized via descriptive statistics by data type. 
Visit schedule 
Visit,  
 
Number,  
(Time point) 
Screening  
 
Visit 1 
(<2m pre-
procedure) 
B-Laser™ 
procedure  
Visit 2 
(to 
discharge) 
Follow up  
 
Visit 3  
(30d ± 5d 
post 
procedure) 
Follow up 
 
Visit 4  
(6m ± 2w 
post 
procedure) 
Informed consent 
X 
 
 
 
Assess eligibility 
X 
 
 
 
Medical history & 
demographic  
X 
 
 
 
Blood Tests 
X 
 
 
 
Con-meds 
X 
X 
X 
X 
Baseline 
lesion 
evaluation  
X 
X 
 
 
Short 
Physical 
examination  
X 
 
 
 
Ankle-Brachial 
Index 
X 
 
X 
X 
Rutherford 
Classification  
X 
 
X 
X 
WIQ 
X 
 
X 
X 
& 
Confirm 
eligibility 
per 
intraoperative 
inclusion/exclusion 
 
X 
 
 
PAD Intervention 
including B-Laser™ 
Atherectomy 
 
X 
 
 
Safety- AE, SAE, 
MAE, ADE 
 
X 
X 
X 

Safety and Effectiveness Evaluation of Eximo 
Medical’s B-Laser™ atherectomy Device, in Subjects 
Affected with Infrainguinal PAD 
Date:   
02 Oct 2017 
PRODUCT: Eximo Medical B-LaserTM  for PAD 
Page 5 of 5 
Document number: EX-PAD-03 
Revision: 02 
 
Results 
Primary Effectiveness Results 
At baseline, the mean (SD) percent stenosis at the target lesion was 85.7% 
(12.2%). Post B-LaserTM prior to adjunctive therapy, the mean (SD) percent 
stenosis at the target lesion was 52.1% (14.9%0.  This resulted in a crude 
mean (SD) reduction from baseline to post B-LaserTM of 33.6% (14.2%). 
 
Primary Safety Results 
The freedom from MAE through the 30-day follow-up period after 
intervention was 98.9%, with a lower limit of the one-sided 97.5% exact 
binomial confidence interval of 94.2%, which is greater than the pre-
specified threshold of 85%, so the success criteria for this endpoint is met.  
Discussion and 
Conclusions 
The aim of the study was to assess the safety and efficacy of the use of the 
Eximo Medical’s B-LaserTM catheter in subjects affected with infrainguinal 
PAD.  The study was designed to assess both safety and effectiveness of the 
device, and there were two hypotheses in this study.   
The primary effectiveness endpoint was the mean reduction from baseline in 
residual diameter stenosis (measured in percent), prior to any adjunctive 
therapy, achieved by the B-LaserTM catheter, as assessed quantitatively by 
the core laboratory based upon the procedure angiograms.  Because the 
lower limit of the one-sided 97.5% confidence interval was greater than 
20%, we conclude that the mean reduction from baseline in diameter 
stenosis is > 20% prior to any adjunctive therapy, and the success criterion 
for this endpoint is met. 
The primary safety endpoint is the percent of subjects free of MAEs 
throughout the 30-day follow-up period, as adjudicated by the Clinical 
Events Committee (CEC).  This hypothesis was tested via the lower limit of 
the one-sided 97.5% exact binomial confidence interval.  Because the lower 
limit of the confidence interval was greater than 85%, this endpoint is met. 
Thus, the study is deemed successful as both null hypotheses (primary 
efficacy and primary safety endpoints) were rejected and the acceptance 
criteria were met.  It can be claimed that Eximo Medical’s B-LaserTM device is 
safe and effective according to its intended use. 
The results found were quite robust.  There did not appear to be statistically 
significant differences in the primary effectiveness endpoint across centers 
(p=0.3071) and there was only 1 non-device related MAE though 30 days, 
suggesting a very strong safety profile. 
The 6-month observational outcomes showed a global improvement of the 
peripheral artery disease symptoms. 
An independent Data and Safety Monitoring Board has also reviewed and 
evaluated the results and affirmed that based on the information that the 
committee was provided, the device is safe for its intended use.