Midterm Results Published From Pilot Study of LimFlow's pDVA System
August 1, 2017—LimFlow SA announced that midterm outcomes from the pilot study of the LimFlow percutaneous deep vein arterialization (pDVA) system for the treatment of no-option critical limb ischemia (CLI) were published online by Steven Kum, MD, et al in the Journal of Endovascular Therapy (JEVT). Dr. Kum of Changi General Hospital in Singapore is the Primary Investigator of this prospective, open-label, single-arm study. The company noted that the LimFlow system is a purely percutaneous device for the treatment of end-stage CLI when all other revascularization efforts have been exhausted.
According to the company, the study encompassed seven no-option CLI patients with an average age of 85 years. All patients had diabetes and were Rutherford class 5 or 6, with six of seven patients also classified as WIfI (Wound Ischemia foot Infection) “high risk.”
All primary safety endpoints were met in 100% of patients, with no deaths, above-the-ankle amputations, or major reinterventions at 30 days. All patients demonstrated symptomatic improvement with the formation of granulation tissue, resolution of rest pain, or both. The technical success rate was 100%.
Six of seven patients had avoided major amputation at 6 months, and five of seven patients had done so at 12 months. Complete wound healing was achieved in four of seven patients at 6 months and in five of seven patients at 12 months. The median healing time was 4.6 months. Perfusion rose dramatically in the LimFlow patients, from 8 mm Hg preprocedure to 59 mm Hg (P = .08) at the time of healing.
LimFlow reported that the investigators concluded in JEVT, “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.”
The investigators also commented, “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.”
There were two instances of myocardial infarction within 30 days, each with minor clinical consequences. Three patients died of causes unrelated to the procedure or device at 6, 7, and 8 months, respectively.
The LimFlow system 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 multidisciplinary team approach. The device uses the company's 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 device received CE Mark approval in October 2016 and is available commercially in Europe. In the United States, the LimFlow system is available for investigational use only. It has not been approved for sale in the United States, Canada, or Japan. Enrollment is currently being conducted in the United States feasibility study and the international postmarket multicenter study to validate these early findings, stated LimFlow.