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LimFlow SA, developer of minimally-invasive technology for the treatment of end-stage critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for a feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.

When all other therapeutic options have been exhausted and a CLI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and rush oxygenated blood back into the foot. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, promotes wound healing and prevents major amputation.

The feasibility study is a multi-center, prospective, single-arm study to be conducted at three U.S. centers encompassing 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 two years. The primary investigator is Jihad Mustapha, MD, FACC, FSCAI, director of Cardiovascular Cath Labs, Endovascular Interventions and Cardiovascular Research at the University of Michigan Metro Health Hospital.

“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,” said Dr. Mustapha. “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.”

CLI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and high blood pressure, many of which are growing health problems. Patients with CLI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLI, appropriate patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

“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,” said LimFlow Chief Executive Officer Dan Rose. “By reinventing the peripheral anatomy to address this major clinical issue, we are providing an alternative for patients who have none today.”

First-in-man and CE Mark clinical studies have been completed for the LimFlow System. The initial clinical results have been presented at the Amputation Prevention Symposium (AMP) and the Vascular International Advances Annual Conference (VIVA), and journal publication of these results is expected soon. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe.