First Patient in U.S. LimFlow Feasibility Study

LimFlow SA has seen the enrollment of a first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.

Background

LimFlow is a private, venture-backed medical device company transforming the treatment of Critical Limb Ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease and an aging population.

The LimFlow pDVA system is a purely percutaneous device for the treatment of end-stage critical limb ischemia (CLI) when all other revascularization efforts have been exhausted. It is designed to restore perfusion to the ischemic foot, which may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients when used as part of a multi-disciplinary team approach. It uses proprietary ultrasound-guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein to vascularize the ischemic foot.

The feasibility study is a multi-center, prospective, single-arm study to be conducted at three U.S. centers encompassing 10 “no-option” CLI patients. Endpoints include amputation-free survival at one month, patency, limb salvage and wound healing. Subjects will be followed out to two years.  This clinical trial is the initial step towards a U.S. approval pathway for the LimFlow System.

The first patient was treated on July 5, 2017 at Metro Health – University of Michigan Health by Jihad A. Mustapha, MD, FACC, FSCAI.

The LimFlow System received the CE Mark in October 2016 as we reported here, and is currently available commercially in Europe.

Investigator comments

“The only other disease with worse life expectancy than CLI is pancreatic cancer. Because of the mortality rate associated with amputations due to ischemia, a new approach to treat CLI is needed now more than ever.  In the LimFlow study, we hope to help patients with no other options that are on their way to amputation” said Dr. Mustapha, the study’s primary investigator.

Company comments

“With approximately 150,000 ischemic amputations annually in the U.S. costing the healthcare system many, many billions of dollars, we look forward to further exploring the promise of LimFlow and its role in treating the epidemic of Critical Limb Ischemia,” said LimFlow Chief Executive Officer Dan Rose.

Source: LimFlow SA

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