US FDA grants IDE approval to LimFlow for Percutaneous Deep Vein Arterialisation system

LimFlow system

The US Food and Drug Administration (FDA) has approved LimFlow’s Investigational Device Exemption for a feasibility study of the company’s Percutaneous Deep Vein Arterialisation (pDVA) system. When all other therapeutic options have been exhausted and a critical limb ischaemia 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.

The feasibility study is a multicentre, prospective, single-arm study to be conducted at three US centres encompassing 10 end-stage—or “no option”—critical limb ischaemia 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, director of Cardiovascular Cath Labs, Endovascular Interventions and Cardiovascular Research at the University of Michigan Metro Health Hospital, Wyoming, USA.

“The vascular interventions we have today to treat critical limb ischaemia 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 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 critical limb ischaemia. This therapy may allow us to give hope to many of the 120,000 patients annually who otherwise must suffer a major limb amputation.”