LimFlow Initiates Trials of Its Percutaneous Deep Vein Arterialization System
July 11, 2017—LimFlow SA announced enrollment of the first patient in the United States feasibility study of the LimFlow percutaneous deep vein arterialization (pDVA) system. The company also announced the initiation of a multicenter, prospective, single-arm postmarket surveillance study in Europe and Asia.
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 by using ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow into the tibial vein to vascularize the ischemic foot. The company is based in Paris, France.
According to LimFlow, the United States feasibility study is a multicenter, prospective, single-arm study that will be conducted at three United States centers and composed of 10 “no-option” CLI patients. Endpoints include amputation-free survival at 1 month, patency, limb salvage, and wound healing. The patients will be followed out to 2 years. The study's primary investigator Jihad A. Mustapha, MD, treated the first patient on July 5 at Metro Health—University of Michigan Health in Wyoming, Michigan.
The company stated that the postmarket surveillance study will enroll up to 50 Rutherford Class 5 and 6 “no-option” patients in several CLI centers of excellence in Europe and Asia. Patients will be followed out to 1 year, and endpoints include amputation-free survival and wound healing progression. Data collection is aligned with the United States feasibility study, allowing for a large comparable data set for the use of the LimFlow system in this “no-option” CLI sub-group.
“The only other disease with worse life expectancy than CLI is pancreatic cancer," commented Dr. Mustapha in the company's announcement. "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.”
The company advised that the clinical trial is the initial step towards a United States approval pathway for the LimFlow system. The LimFlow system received CE Mark approval in October 2016 and is available commercially in Europe. In the United States, the LimFlow system is only available for investigational use. It has not been approved for sale in the United States, Canada, or Japan.