TOLEDO, Ohio, March 1, 2018 /PRNewswire/ -- VentureMed Group, Inc., a medical device company specializing in the development and commercialization of innovative and cost effective devices for the endovascular treatment of peripheral arterial disease (PAD), released today the early post market data of the FLEX Catheter®. The report was presented at the Leipzig Interventional Course (LINC) 2018 conference in three (3) scientific abstracts earlier in February. LINC is an international live course conference dedicated to the collaboration, understanding, and development of endovascular therapies. Attendance nearly reached five thousand participants with eighty-nine (89) live cases featured from thirteen (13) centers.
The FLEX is a safe and effective vessel prep device engineered to create continuous longitudinal micro-incisions prepping the vessel for angioplasty. Created as a one size fits all device, the FLEX, utilizes a basket equipped with 3 atherotomes that contour to the vessel wall. The real-world outcomes highlight the benefits of the FLEX.
Dr. Louis Lopez, Director of the Cardiac Catheterization Lab of Saint Joseph's Hospital in Fort Wayne, Indiana, presented multi-center acute results of 237 femoropopliteal lesions entitled: "FLEX Catheter: A Novel Device Facilitating in the Preparation of Vessels for Angioplasty." The average lesion length treated was 136 mm, including chronic total occlusions (43%), in-stent restenosis (8%) and moderate to severe calcium (51%). According to Dr. Lopez, "The angiographic results show that FLEX safely achieved a luminal gain prior to angioplasty without flow-limiting dissection, perforations, or embolization. Additionally, low balloon inflation pressures were noted, suggesting improvement in the vessel compliance with use of the FLEX."
Dr. Jihad Mustapha, Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids Michigan, separately presented "Early Clinical Results of the FLEX Catheter in the Treatment of Below the Knee Lesion." The data analyzed acute results of 27 below the knee (BTK) cases, 52% were chronic total occlusions. The technical success of the FLEX, defined as a luminal gain created prior to angioplasty, was 100%, with an average luminal gain of 27%. There were no occurrences of flow-limiting dissections, emboli, or perforations. The data suggested the FLEX is a useful device in treating below the knee lesions.
Furthermore, Dr. Lopez presented a challenging case: "Recanalization of a Chronic Total Occlusion in a Popliteal Artery Using a FLEX Scoring Catheter Prior to Drug Coated Balloon." Chronic total occlusions in the posterior and anterior tibial arteries were prepped with the FLEX catheter prior to a drug coated balloon. The posterior and anterior tibial arteries were successfully treated, creating a patent pedal arch without the need for stenting and no adverse events occurred.
"This initial analysis of the data supports that FLEX is a safe and effective vessel prep device to facilitate the dilatation of stenoses in a variety of femoropopliteal lesions," said John Pigott, MD, Founder and Chief Science Officer of the Company. A significant luminal gain is created by the FLEX prior to angioplasty without flow-limiting dissections, emboli, or perforation. A low rate of minor dissections occurs, 5% in all cases, lowering the necessity for stenting. Additionally, the vessel wall compliance is greatly improved and a larger surface area for drug uptake is created.
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.
Gary L. Smith, CEO
SOURCE VentureMed Group, Inc.