First time data release: Initial experience with the temporary Spur Stent System: DEEPER Trial first-in-man results Jihad A. Mustapha, MD, FACC,
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1 First time data release: Initial experience with the temporary Spur Stent System: DEEPER Trial first-in-man results Jihad A. Mustapha, MD, FACC, FSCAI Associate Professor of Medicine Michigan State University, E. Lansing, MI USA Chief Executive Officer Advanced Cardiac & Vascular Amputation Prevention Centers Grand Rapids, MI USA
2 Disclosure Speaker name: Jihad A. Mustapha I have the following potential conflicts of interest to report: BD Bard (consultant, physician trainer, MAB & research) Boston Scientific (consultant, MAB & reseearch) Biothelium (consultant) Cagent Vascular (consultant & research) Cardio Flow (chief medical officer, board member, shareholder & research) Cardiovascular Systems, Inc. (consultant, physician trainer& research) Medtronic (consultant, phyisican trainer) Micromedical Systems (chief medical officer) Philips (consultant & physician trainer) PQ Bypass (consultant & research) Reflow Medical (SAB & research) Terumo Medical (consultant & research)
3 Tibial arterial disease is mostly located in the arterial wall A B J.A Mustapha MD, et al, Cardiovascular intervention
4 Red dye with paclitaxel
5 Reflow Medical s Temporary Spur Stent System Design Temporary Self-Expanding Frame Open Lumen Calcification/Artery Penetrating SPURs
6 Multiple Progression Clinical Approach + + = PTA Temporary Spur Stent Drug Coated Balloon
7 Clinical Application SPUR is very effective in: -Moderate and Severe Calcium -Elastic Recoil -Vessel Tortuosity & Length -Drug Administration Left Peroneal (INDEX) N=12 VS 34% recoil at 15 min of 97% of the patients post Balloon angioplasty Bauman et al
8 DEEPER Trial DEEPER Trial: A Non-RandomizeD FEasibility Trial of the Spur SystEm for the Treatment of Lesions in the InfraPoplitEal ArteRy Primary Efficacy Endpoint: Binary arterial flow of treated lesion sites by continuous wave doppler through 6 months Primary Safety: Freedom from device and procedure-related death through 30 days post-procedure Freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months post procedure. Conducted in the Dominican Republic, Santo Domingo (Dr. Ammar Ibrahim): Oct 2017 May 2018 Principal Investigator: Dr. Jihad Mustapha Date Treated Number of Patients Treated Arteries (SPUR + DCB) Follow Up Progress 30 Day 3 Months 6 Months 1 Year Oct * 3 Nov * 4 Feb Feb 2019 May ** 7 May 2019 Total (23) * and 11-04: Excluded noncompliance ** 05-02: Excluded, SPUR only, 05-09: Anomalous Artery, exclusion criteria
9 Demographics and Risk Factors (n=19 pts) * 20 arteries treated in 19 pts N=19 Variable Value Age, yr 71 (55, 86) Female sex 14 (75%) Diabetic 95% (18/19) Hypertension: 13/19 (65%) Smoker 2/19 (1%) Hyperlipidemia (HLD) 6/19 (30%) Chronic Kidney Disease (CKD) 7/19 (35%) Rutherford class Target artery 3 4 (21%) 4 2 (11%) 5 13 (68%) Posterior tibial 7 (35%) Peroneal 8 (40%) Anterior tibial 5 (25%) Diameter stenosis, % 99 (80, 100) Stenosis 90% 9/20 (45%) TASC Classification A 0% B 5.3% C 31.5% D 63.1%
10 Clinical/Procedural Data Variables Value Access Antegrade (100%) Technical Success (Deployed and Retrieved) Dissections from initial predilatation 100% (n=45 systems) 7 (type A) Dissections caused by the SPUR 0 Bailout Stent 0 CTO length,mm 63 (20, 130) No. SPURs used 2 (1, 5) SPUR Treated Length, mm 110 (60, 270)
11 Primary Endpoint: Safety Endpoint DEEPER Trial Results TLR (12-mo) % 0% [0/6] Amputation rate (major, 12-mo)% 0% [0/6] All cause mortality (30 day)% 0% [0/19] Amputation rate (major, 9-mo)% 0% [0/19]
12 Primary Endpoints (6 Month Efficacy*) DEEPER Trial (N=19) Free from Primary Efficacy Failure at 6 Months Angio ** (12/14) Ultrasound ** (16/20) 86.0% 80.0% * Freedom at 6 months from major index limb amputation, target lesion occlusion and TLR ** Corelab Adjudicated: Vascore + Syntropic
13 Wound Healing PT Baseline Wound 30 Day 3 Month 6 month PT Baseline Wound 30 Day 3 Month 6 month NA
14 Summary Promising Technology : Benefiting Patients Continued Expansion DEEPER OUS, 2019 Multicenter, 100 patients, Spur + DCB (various) Holden (NZ), van den Berg (Switzerland), Schmidt & Scheinert (Germany) and Zeller (Germany)
15 First time data release: Initial experience with the temporary Spur Stent System: DEEPER Trial first-in-man results Jihad A. Mustapha, MD, FACC, FSCAI Associate Professor of Medicine Michigan State University, E. Lansing, MI USA Chief Executive Officer Advanced Cardiac & Vascular Amputation Prevention Centers Grand Rapids, MI USA
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