LimFlow hopes to give end-stage CLI patients an alternative to amputation with its pDVA system

Earlier this year the FDA accepted LimFlow’s Percutaneous Deep Vein Arterialization system into its Breakthrough Device Program. CEO Dan Rose is hopeful that that designation, along with an increased feasibility study size, will help get the company’s pDVA product to critical limb ischemia patients in the US facing limb amputations with no other options. “There are over 270,000 ischemic major amputations in U.S. and Europe every year and these patients have no option today,” Rose said in an interview with MassDevice.com. “We’re really trying to provide a new solution for patients who have exhausted all their other options.” Started in 2012 by Dr. Martin Rothman, LimFlow has had its sights set on treating end state critical ischemia since formation, according to CEO Dan Rose. The company’s flagship product, the pDVA system, is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. It uses ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow to the tibial vein to vascularize the affected feet. “The concept of Limflow is to leverage the fact that, as we all know, you have an arterial tree that supplies blood to every part of your body, including your foot – you also have a venous tree that takes blood back to the heart,” Rose said. “What we do instead of using the highly diseased arter...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Food & Drug Administration (FDA) Vascular LimFlow Source Type: news