LimFlow touts pDVA pilot trial data, technical success rate

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 ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Clinical Trials Diabetes LimFlow Source Type: news