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 widespread available option we currently have in the U.S. is amputation, which has a terrible impact on a patient’s quality and length of life. The opportunity to have a minimally-invasive treatment that offers a new option for late-stage patients is a very exciting prospect as we seek to address the growing epidemic of CLI. This therapy may allow us to give hope to many of the 120,000 patients annually who otherwise must suffer a major limb amputation,” primary investigator Dr. Jihad Mustapha said in a prepared release.
Last November, LimFlow said it won CE Mark approval in the European Union for its percutaneous LimFlow system designed for venous arterialization of the lower limbs for peripheral artery disease patients.
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