LimFlow said today it launched a US feasibility study of its LimFlow percutaneous deep vein arterialization system designed for treating end-stage clinical limb ischemia.
LimFlow’s pDVA system is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. The system uses ultrasound-guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow to the tibial vein to vascularize the affected feet.
The 1st patient in the trial was treated at the University of Michigan Health’s Metro Health by Dr. Jihad Mustapha, the Paris-based company said.
“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,” primary investigator Dr. Mustapha said in a prepared statement.
LimFlow said the trial is a multicenter, prospective, single-arm study that will be conducted at 3 US centers for a total of 10 “no-option” CLI patients, with endpoints including amputation-free survival at 1 month, patency, limb salvage and wound healing.
Subjects will be monitored out to 2 years, and the company hopes results from the trial will support FDA approval of the device.
“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,” CEO Dan Rose said in a press release.
LimFlow said it also initiated a post-market surveillance study, slated to enroll 50 Rutherford Class 5 and 6 “no-option” patients across the EU and Asia. Patients in that trial will be followed for a year, with similar endpoints ot the US trial, LimFlow said.
The company won FDA investigational device exemption for the trial in patients with end-stage critical limb ischemia in April.