Perspective on initial Limflow experience in the US. Peter A. Schneider, MD Kaiser Foundation Hospital Honolulu, Hawaii

Transcription

1 Perspective on initial Limflow experience in the US Peter A. Schneider, MD Kaiser Foundation Hospital Honolulu, Hawaii

2 Disclosure Peter A. Schneider Potential conflicts of interest to report: Enter patients in studies sponsored by: Gore, Cordis, Medtronic, Silk Road, Bard, NIH, Limflow Modest royalty: Cook Scientific Advisory Board (non-compensated): Abbott, Medtronic, Boston Scientific Chief Medical Officer: Intact Vascular, Cagent

3 LimFlow Trials Overview ` Pilot Pre and Post CE Mark U.S. Feasibility (EFS) OUS Post- Market U.S. Pivotal # Patients # Centers Protocol Single-center, prospective, open label Multi-center, prospective, open label Multi-center, prospective, single-arm Multi-center, prospective, single-arm Multi-center, prospective, efficacy and safety study Enrollment Sep 2013-Nov 2014 Mar 2015 Mar Countries Singapore France, Germany, Italy, Netherlands, Singapore U.S. EU, Singapore U.S., TBD The LimFlow System is approved for sale in markets regulated by the CE Mark. Caution: Investigational device in the United States. Limited by U.S. federal law to investigational use only in the U.S.

4 Limflow Early Feasibility Study Design Key Endpoints Amputation-Free Survival 30 days, 6 months Patency 30 days, 6 months Wound Healing 3, 6, 9, 12 months Technical Success Procedural Success Key Inclusion/Exclusion Inclusion: Rutherford 5/6 No Option CLI Approval by ISC Exclusion: Active infection Dialysis Severe heart failure Follow-Up Schedule BL 1M 3M 6M 9M 1Y 2Y Wound Assessment TcPO2 Doppler 4

5 Limflow Early Feasibility Considerations Reduction of Variables Independent Screening Committee Refining protocol with KOL input Thorough Data Collection Procedural Standardization Quantitative wound care assessment Perfusion evaluation Vascular interrogation ekare TcPO2 DUS Systematic Procedural Approach Recognition of evolving procedure Documentation and review of every case WIfI 5

6 Severe Ischemia No Option CLI Group No Option definition No distal pedal arterial target OR Distal pedal target without ipsilateral autologous single segment conduit Chronic Wounds 1. No option patients have no remaining acceptable target vessels for intervention. 2. Patients with Ischemic Foot Wounds typically do not heal without successful reperfusion. 3. Amputation often the only remaining option. 4. No option = 14-20% of CLI population

7 No Option Patient Trajectory is Miserable Baseline Conservative Treatment Amputation Once Amputated Up to 10% die before hospital discharge 20-37% have major complications Average 19 Hospital Admissions / year Rack up to $800k in direct healthcare cost Norgren and al, JEVS 33, S1-S70 (2007) Yost ML. The economic cost of vascular amputation. Atlanta (GA): The Sage Group. In press

8 No Option Patient with pdva Baseline Immediately Post-Procedure Schneider EFS Patient: 65 y/o M, Rutherford 5, Type II Diabetes, WiFI 231 Nonhealing wound (lateral aspect), absence of adequate target artery, no vessel visualized in the foot CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

9 No Option Patient with pdva Baseline Immediately Post-Procedure Mustapha EFS Patient: 71 y/o M, Rutherford 6, Type II Diabetes, WiFI 332 Extensive tissue loss over the 5th toe amputation site. Has no (traditional) endovascular options and no open surgical revascularization options. CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

10 Wound Evolution post pdva Baseline 1 Month 3 Month Schneider Area: 17.8 cm 2 Volume: 1.5 cm 3 Area: 7.7 cm 2 Volume: 0.8 cm 3 Area: 6.1 cm 2 Volume: 0.5 cm 3 CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

11 Wound Evolution post pdva Baseline 1 Month 3 Month Area: 15.9 cm 2 Volume: 5.6 cm 3 Area: 5.5 cm 2 Volume: 0.4 cm 3 Mustapha Area: 0.4 cm 2 Volume: 0.0 cm 3 CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

12 Limflow Pivotal Trial Background Europe Commercially Available (CE Mark: Oct 16) Post-Market Study Ongoing United States Important Focus on Collaboration: Early Feasibility Study Program (EFS) EFS expanded from 10 to 25 Patients Breakthrough Technologies Program (alias Expedited Access Pathway - EAP) Proposed wadaptive Design Potential pooling of OUS Post-Market Study KOLs FDA US Trials LimFlow 12

13 Expanded EFS - Study Centers EFS Sites Invited Sites 13

14 Limflow Next Steps Dialysis to include or exclude? Wound care after reversal Mechanism of action Venous anatomy characterization 14

15 Dialysis Population: Unmet Need

16 Ideal Treatment Environment Prosthetist Diabetologist Plastic Surgery Podiatrist Ischemic Foot Vascular Specialist Nurses Infectious Disease Specialist Amputation Prevention Multidisciplinary Team 16

17 Initial US Limflow Experience Conclusion Fills an unmet need for No Option patients. Significant trial design challenges. Initiates several areas of scientific inquiry. Truly optimistic about possibilities.

18 Perspective on initial Limflow experience in the US Peter A. Schneider, MD Kaiser Foundation Hospital Honolulu, Hawaii