The FDA has approved an Investigational Device Exemption for a feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System for the treatment of critical limb ischemia (CLI), a severe form of peripheral artery disease.
The minimally invasive pDVA system is designed for “no option” CLI patients who have exhausted other therapeutic options and are facing major amputation.
Its goal is to bypass blocked arteries in the leg and rush oxygenated blood back into the foot. This restoration of perfusion in the lower limbs may help resolve chronic pain, improve quality of life, promote wound healing, and prevent amputation, according to LimFlow SA in a media release.
The multi-center, prospective, single-arm study of the pDVA System will be conducted at three US-based centers, and will include 10 end-stage—or “no option”—CLI patients. Endpoints include amputation-free survival at one month, patency, limb salvage and wound healing, and the subjects 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 US is amputation, which has a terrible impact on a patient’s quality and length of life,” says Jihad Mustapha, MD, FACC, FSCAI, the study’s primary investigator, in the release.
“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,” adds Mustapha, director of Cardiovascular Cath Labs, Endovascular Interventions and Cardiovascular Research at the University of Michigan Metro Health Hospital.
“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,” states LimFlow Chief Executive Officer Dan Rose, per the release. “By reinventing the peripheral anatomy to address this major clinical issue, we are providing an alternative for patients who have none today.”
The LimFlow technology is approved for investigational use only in the United States and has not been approved for sale.
The US headquarters of Paris-based LimFlow SA are located in Santa Clara, Calif.
[Source(s): LimFlow SA, Business Wire]