Toledo, Ohio, June 4, 2019 – VentureMed Group, Inc., a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced new data presented at the 20th Annual New Cardiovascular Horizons (NCVH) Annual Conference, May 29-31, in New Orleans, Louisiana.
The study utilized intravascular ultrasound (IVUS) to assess the reduction in the rate and severity of dissections in peripheral arteries when the FLEX Vessel Prep System was used prior to angioplasty.
“Dissections are grossly under-appreciated on angiogram when compared with IVUS. Percutaneous transluminal balloon angioplasty (PTA) causes dissections and stretching of the vessel to restore blood flow. However, the severity and depth of the dissections can contribute to restenosis.” said lead investigator Nicolas W. Shammas, MD, MS, EJD, FACC, FSCAI, research director, Midwest Cardiovascular Research Foundation in Davenport, Iowa. “This is a positive signal as these results showed a low rate of dissection after using the FLEX VP System with the majority of those dissections being lesser in depth and circumference.”
Study details and findings:
<180° in circumference (81.1%). Vessel prep involving only the layers superficial to the internal elastic lamina may prevent restenosis.
A Comparative Review of the FLEX VP
System in the Treatment of Femoropopliteal Lesions of Differing Lengths –
real-world data of 443 femoropopliteal cases.
“This data highlights the importance of the unique FLEX VP mechanism of action that provides acute luminal gain and improved vessel compliance to reduce PTA balloon opening pressures leading to meaningful clinical results,” said Jason A. Yoho, MD, Interventional Cardiologist at the Heart and Vascular Institute of Texas. “This real-world data on the use of the FLEX VP System is clinically relevant and important as we continue to evaluate options that may help patients achieve better clinical outcomes.”
Study details and finding:
“The data from these clinical studies assessing the use of the FLEX VP System provides physicians with important information as they develop effective tools to help improve outcomes for patients. The results of the FLEX iDissection study and this post-market surveillance data continues to build a strong case for the use of the FLEX VP System to facilitate PTA of choice and deliver positive outcomes,” said J. Robert Paulson Jr., chief executive officer and president of the VentureMed Group.
Founded in 2012, the VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts. The Flex VP System facilitates an ideal environment for treating PAD and AV fistulas and grafts by safely creating linear, parallel micro-incisions in plaque of any length to deliver acute lumen gain and vessel compliance enabling better clinical outcome for patients. The true vessel prep FLEX technology is currently indicated for use in femoropopliteal arteries and restoring access to AV fistulas and grafts. The FLEX VP System received CE Mark in 2015 and 510(k) clearance from the US Food and Drug Administration in 2016. For more information, visit www.flexvesselprep.com.