The Food and Drug Administration (FDA) has granted additional approval for VentureMed’s FLEX Vessel Prep System for use in the treatment of in-stent restenosis (ISR) in the peripheral vasculature.
The FLEX Vessel Prep System was originally cleared to modify plaque by creating controlled micro-incisions along the entire length of complex lesions of varying morphology.
It was previously granted FDA 510(k) clearance and CE marking for marketing and sale in the EU.
As part of a standard percutaneous transluminal angioplasty (PTA) and / or drug-coated balloon (DCB) angioplasty procedure, patients, undergoing peripheral vascular interventions, sometimes receive a balloon-expandable or self-expanding stent to keep the artery open.
Approximately 30% to 40% of patients experience excessive tissue growth inside the surface of the stent within two years of undergoing stent implantation for the femoropopliteal disease. They also face the recurrence of the narrowed artery, which restricts blood flow.
VentureMed president and CEO Robert Paulson Jr said: “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.
“FLEX allows physicians to modify plaque and prepare diseased vessels of any length to optimise their choice of definitive revascularisation therapy, and now as part of treating patients with femoropopliteal ISR, helping to reduce the risk of recurrent ISR.”
Although it is clinically challenging to modify the obstructive neointimal tissue that often forms within peripheral stents, it is important to effectively restore blood flow and maintain vessel patency.
VentureMed’s FLEX Vessel Prep System facilitates and optimises the treatment of these vessels by lancing along the entire length of the ISR lesions.