January 30, 2020
Real-World Data Presented for VentureMed’s Flex Vessel Prep System to Treat Long CTOs
January 30, 2020—VentureMed Group, Inc. announced that data for the company’s Flex vessel preparation (VP) system were presented at ISET 2020, the International Symposium on Endovascular Therapy held January 22–25 in Hollywood, Florida.
Investigators conducted a multicenter retrospective review of 185 real-world patients treated with the Flex VP system for long (≥ 8 cm) chronic total occlusions (CTO) in complex vessel anatomy.
According to the company, revascularization was successful in all 185 CTOs, with no major complications. After treatment with the Flex system, vessel compliance improved because of subnominal inflation pressures.
Specifically, there was a 34% mean luminal gain after treatment versus before treatment with the Flex VP system. Subnominal inflation pressures averaged 4 atm. There was a low rate (4%) and grade (A or B) of dissections in lesions averaging 20.8 cm. There were no flow-limiting dissections, perforations, or embolization. Provisional stenting was done in 28% of cases.
Constantino Pena, MD, commented in the company’s press release, “Complex lesions in the femoral and popliteal arteries are common, and if not prepared properly, can encounter dissections, embolizations, and other complications. Vessel preparation is a key component of a successful revascularization. The Flex system delivers safe, easy, and efficient vessel preparation that potentially delivers better outcomes and improved efficiencies in the lab.” Dr. Pena is Medical Director of Vascular Imaging at Miami Cardiac and Vascular Institute in Miami, Florida,
VentureMed Group stated that the Flex VP system is designed to optimize revascularization of long, complex lesions by creating controlled depth microincisions along the entire length of mixed morphology and asymmetrical diseased vessels to prepare lesions for drug-coated balloons or other therapies. The microincision pathways created with the Flex system potentially enhance and facilitate drug access to diseased vessels.
The Flex VP system has received FDA 510(k) clearance in the United States, as well as European CE Mark approval.