LimFlow today released results from the pilot study of its LimFlow percutaneous deep vein arterialization system, touting that the trial met all its safety endpoints and had a technical success rate of 100%.
The French company’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.
“PDVA is an innovative approach for treating no-option CLI and represents an alternative option for the ‘desert foot,’ potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort,” study authors wrote in their conclusion.
Researchers in the prospective, open-label, single-arm pilot study examined the use of the pDVA system on 7 no-option CLI patients with an average age of 85. Patients in the trial had diabetes and were Rutherford Class 5 or 6, with 6 of 7 classified as having wound ischemia foot infections at high risk.
All primary safety endpoints in the trial were met in all patients with no deaths, above-the-ankle amputations or major reinterventions at 30 days. Patients in the trial demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both, LimFlow said, with a reported 100% technical success rate.
“The immediate angiographic appearance was dramatic. One patient who had prior lumbar sympathectomy and was on high doses of opioids for chronic pain had a dramatic resolution of her pain within 48 hours and was opioid free,” study authors wrote.
At 6-months, 86% of patients did not have to undergo a major amputation, while 71% avoided major amputations at 1 year. Complete wound healing was achieved in 57% of patients at 6 months, and 71% of patients at 12 months. Median healing time in the trial was 4.6 months, the company said.
Researchers reported significant rises in perfusion through tissues in the foot from 8 mmHG pre-procedure to 59 mmHG at the time of healing.
Data from the trial indicated 2 instances of myocardial infarction within 30 days with minor clinical consequences. A total of 3 patients died due to causes unrelated to the procedure or device at 6, 7 and 8 months respectively.
“It is our mission to reduce the incidence of amputation, resolve pain and promote wound healing in a previously hopeless patient population and we are very encouraged by the early promising results of the LimFlow System. The high technical success rate also demonstrates that our novel concept of percutaneous and minimally-invasive bypass below the knee is an achievable and reproducible technique. We look forward to the results from our U.S. feasibility study, which is currently enrolling, and our international post-market, multi-center study outside of the U.S. to validate these early findings,” CEO Dan Rose said in a prepared statement.