LimFlow wins FDA IDE to launch end-stage CLI treatment trial

LimFlow said today it won FDA investigational device exemption to launch a feasibility study of its LimFlow percutaneous deep vein arterialization system in patients with end-stage critical limb ischemia. The company said that the study will examine the use of its system in treating CLI patients facing major amputations. The system is designed to bypass blocked arteries in the leg and rush oxygenated blood back into the foot. LimFlow said that for many patients, restoring perfusion in the lower limbs can resolve chronic pain, improve quality of life, promote wound healing and prevent major amputations. “There are far too many amputations performed in the world today, costing the healthcare system many billions of dollars and ruining countless lives. LimFlow’s mission is empowering vascular specialists to offer new hope to their CLI patients who may be only days away from losing a limb. By reinventing the peripheral anatomy to address this major clinical issue, we are providing an alternative for patients who have none today,” CEO Dan Rose said in a press release. The multi-center, prospective, single-arm feasibility study will look to enroll 10 end-stage CLI patients, with endpoints including amputation-free survival at 1 month, patency, limb salvage and wound healing, the company said. Patients in the trial will be followed out to 2 years. “The vascular interventions we have today to treat CLI can only go so far. Once they have run their course, the only...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Vascular LimFlow Source Type: news