VentureMed recently announced it received FDA 510(k) clearance for its Flex Vessel Prep System for use in treating in-stent restenosis in the peripheral vasculature.
The Flex Vessel Prep System modifies plaque and fibrous stenoses and creates controlled-depth micro-incisions of any length to release circumferential tension and improve vessel compliance.
“Modifying the obstructive neointimal tissue that frequently forms within peripheral stents is clinically challenging, but essential to effectively restore blood flow and maintain vessel patency. The novel way in which the Flex System incises along the entire length of challenging ISR lesions appears to help facilitate and optimize treatment of these vessels, including the delivery of drug-coated therapies,” Eric Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center, said in a news release.
Nearly 30-40% of patients who undergo stent implementation for femoropopliteal disease experience excessive tissue growth inside the surface of the stent and a recurrence of in-stent restenosis, according to the company.
“This expanded ISR indication for Flex provides physicians with a safe and effective tool to address an increasingly common and difficult condition that can result from the implantation of stents to treat femoropopliteal disease,” president and CEO of VentureMed said. “Flex allows physicians to modify plaque and prepare diseased vessels of any length to optimize their choice of definitive revascularization therapy, and now as part of treating patients with femoropopliteal ISR, helping to reduce the risk of recurrent ISR.”