Critical Limb Ischemia (CLI) expert, LimFlow has announced completion of enrollment in the U.S. feasibility study of its Percutaneous Deep Vein Arterialization (pDVA) System. The U.S. FDA has allowed the trial to expand to includemore patients and more sites.
Background
LimFlow SA, develops of minimally-invasive technology for the treatment of end-stage critical limb ischemia (CLI).
The LimFlow device, covered before on our pages is a novel and purely percutaneous therapy for “no-option” CLI patients when all other revascularization efforts have been exhausted and a patient is facing a major amputation.
CLI patients are often treated with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.
The fiendishly clever LimFlow System uses proprietary ultrasound-guided catheters and covered nitinol stents designed to restore perfusion to the ischemic foot by bypassing diseased arteries and diverting blood flow into the tibial vein to vascularize the foot. Achieving tissue perfusion may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients.
LimFlow has announced completion of enrollment of the original 10-patient cohort in the U.S. feasibility study of the pDVA System. The company also announced that the U.S. FDA has accepted the company’s proposal to expand the feasibility study by an additional 15 patients and three new sites, bringing the total number of patients enrolled in the feasibility study to 25 U.S. subjects and six U.S. institutions.
The FDA also accepted the LimFlow System into its Breakthrough Device Program, a designation previously known as the Expedited Access Pathway (EAP). The designation is intended to speed patient access to breakthrough technologies that provide for more effective treatment of life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offers significant advantages over existing approved or cleared alternatives.
The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. It is only available for investigational use in the USA and has not been approved for sale in the USA, Canada, or Japan.
Investigator comments
“This is the biggest advance I’ve seen for people at risk of amputation in my 25 years in practice,” said Daniel Clair, MD, chair of the department of surgery at the University of South Carolina and the Palmetto Health-USC Medical Group, who performed the 10th case in the feasibility study on January 25. “In the past, the only thing we had to offer these no-option patients was a segmental amputation of parts of their foot, and most patients ended up losing their entire foot. Major amputation has a very poor overall prognosis in terms of mortality and quality of life for patients and must be improved.”
Company comments
“We are excited to be among the first technologies treating lower extremity disease to be granted access to the FDA’s Breakthrough Device Program,” said LimFlow Chief Executive Officer Dan Rose. “Their decision recognizes the novelty of our system and the promise it holds in treating the epidemic of critical limb ischemia. Over 100,000 patients in the U.S. have a major ischemic lower limb amputation every year and we look forward to closely collaborating with the FDA to soon bring the LimFlow technology to U.S. patients with no good options today.”
Source: LimFlow SA
published: January 30, 2018 in: Clinical Studies/Trials, Regulatory, Vascular