1. The Endocross Enabler-P: First in-Human Results
Maurice Buchbinder, MD
Foundation for Cardiovascular Medicine
La Jolla, CA

2. Disclosure Speaker’s name: Maurice Buchbinder, MD
 I have the following potential conflicts of interest to report: EndoCross Inc.
 Consulting
 Employment in industry
 Stockholder of a healthcare company
 Owner of a healthcare company
 I do not have any potential conflict of interest 2

3. Current Limitations of CTO Treatments
Despite the advent of new devices / guide wires as well as improved operator technique, success rates remain limited (60-80%)
Unsuccessful attempts are primarily due to inability to cross lesions with a guidewire
Typically CTO procedures are associated with extended procedural time, radiation exposure and increased contrast load.
Treatment of CTO lesions remains highly dependent on operator skill and experience.

4. ENABLER-P System Includes 2 components: Support balloon catheter:
Catheter lumen 0.35 compatible
Catheter length 135cm
Balloon length 20mm
Balloon Diameter 6mm 4

5. Pressure Control Unit (PCU) :
ENABLER-P System
Pressure Control Unit (PCU) :
Disposable, battery operated unit
Allows additional cyclical balloon
Inflations and Deflations 5

6. ENABLER-P System
These reciprocating inflations result in guidewire gripping, balloon elongation which in turn leads to forward movement of the guidewire while increasing axial force at the tip of the wire (18x) 6

7. ENABLER-P System 7

8. First Human Use Experience : Apollo I
Designed to evaluate the Safety and Effectiveness of the ENABLER-P System in crossing Chronic Total Occlusions located in the Superficial Femoral and popliteal Artery 8

9. Case NB-501
41 Year old male with a 50mm occlusion of the mid left SFA.
Moderate calcification
Failed attempt with standard wires
PCU activation : 50sec 9

10. CASE NM-501 10

11. Case NB-501 11

12. Case sample 2: highly calcified occlusion
Highly calcified lesion
Occlusion length: 45mm
System activation duration: 2min
This patient underwent traditional angioplasty attempt
Occlusion
Vessel calcification
GW across occlusion 12

13. Case sample 3: HS-410
71 Year old male with a 40mm occlusion of the right SFA.
Severe calcification
PCU activation : 8min 13

14. Case sample 3: HS-410 14

15. Case sample 3: HS-410 15

16. Case sample 3: long occlusion, retrograde approach
59 Year old male
Occlusion length: 180mm
System activation duration: 22min
Estimated occlusion age: > 12m
Proximal cap
distal cap
Activation
Post dilatation 16

17. Clinical Experience to Date
Patients enrolled: 36
Average age:
66.5 years (41-87)
Occlusions location:
SFA
Occlusions length:
80mm (10mm-340mm)
Vessel diameter:
4-6mm
Calcification level:
12 heavy calcified
15 moderate
9 non-calcified

18. Clinical Results n=36 Successful crossing 31 Serious adverse events
Device related adverse events 1
Procedure related adverse events 3*
Successful revascularization
Average system operation time
5.4 min.
* One Proximal dissection from initial vessel access resulting in guidewire placement into false lumen.
One vessel perforation -performed with a dilatation balloon after the removal of the ENABLER-P Catheter. 18

19. Conclusions
ENABLER-P System is a promising novel device for treatment of Chronic Total Occlusions.
In this early experience the Enabler appears to be safe and effective in crossing challenging long and calcified lesions in the peripheral circulation.
Ongoing evaluation (including below the knee disease) continues to be extremely favorable. 19