TOLEDO, Ohio, March 26, 2018 /PRNewswire/ -- The FLEX Catheter by VentureMed Group, an innovator in vessel prep, was featured in a live case transmission at the International Symposium of Endovascular Therapy (ISET), in Hollywood, FL. ISET focuses on the advancement of endovascular education, promoting discussions, and providing opportunities to explore new technologies and innovative procedural techniques.
Dr. Constantino Pena and Dr. Adam Geronemus from Miami Cardiac and Vascular Institute, Baptist Health South Florida, performed a live case transmitted in real time to ISET treating a severe claudication of the superficial femoral artery in an 81-year-old male. Severe calcium was observed, and vessel prep was designated as the best approach. Dr. Pena stated, "The results of balloon angioplasty can be suboptimal in a lesion with a high degree of calcium as we observed here. After prepping this lesion with the FLEX Scoring Catheter, the subsequent balloon inflated easily and at low pressures. I believe the FLEX Scoring Catheter created an ideal environment for the balloon to dilate."
Dr. Thomas Zeller, Angiology Universitaets-Herzzentrum Freiburg – Bad Krozingen, on the discussant panel commented, "The FLEX is designed for every kind of plaque composition, it works in in-stent, and fibrotic lesions. It seems to reduce the vessel-wall resistance, improves the vessel compliance, and seems to improve the acute outcome of the balloon angioplasty."
Additionally, Dr. Zeller presented "New Devices for Peripheral Occlusive Disease" featuring the FLEX Catheter, and "Early Clinical Results Using the FLEX Scoring Catheter in 100 Femoropopliteal Chronic Total Occlusions." The average lesions length analyzed was 191 mm, with an average luminal gain of 31% achieved by the FLEX prior to angioplasty. No flow-limiting dissection, perforations, or embolization occurred. Provisional stent use was notably low (19%) in this series of long, complicated lesions. The average luminal gain post angioplasty was 92%, suggesting successful recanalizing of chronic total occlusions.
The FLEX was also featured in a poster presentation, "Use of the FLEX Catheter as a New Arteriovenous Access Management Device," authored by Dr. John Ross, Dialysis Access Institute. Fifty-nine cases were evaluated. The FLEX prior to angioplasty demonstrated significant luminal gain (25%), sub-nominal opening balloon pressures (6.5 atm), and reduced the overall residual stenosis (8.2%). Initial clinical experience suggests the FLEX may offer benefits in the management of AV access, especially prior to a drug coated balloon (DCB).
About FLEX Catheter
FLEX is an innovative, non-balloon based dynamic scoring catheter equipped with 3 atherotomes that contour to the vessel wall. By creating continuous longitudinal controlled micro-incisions safely and effectively, FLEX preps the vessel for angioplasty. FLEX was purposefully engineered as a one size fits all device for the treatment of peripheral arterial disease and AV fistula.
About VentureMed Group, Inc.
VentureMed Group™ (VMG) is a commercial stage medical device company that develops and markets innovative medical devices, which enable interventionalists to cost effectively treat peripheral artery diseases and improve the lives of their patients. VMG was founded in 2012 and is based in Toledo, Ohio. FLEX is cleared for sale in the US and carries CE Mark for sales in EU. For more information, visit www.venturemedgroup.com.
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VentureMed Group, Inc.
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