PARIS--(BUSINESS WIRE)--LimFlow SA, developer of minimally-invasive technology for the treatment of end-stage critical limb ischemia (CLI), today announced completion of enrollment of the original 10-patient cohort in the U.S. feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. The company also announced that the U.S. Food and Drug Administration (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 LimFlow device 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.
“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.”
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.
“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.”
CLI is the most severe form of peripheral artery disease (PAD) and often occurs in patients suffering from diabetes, coronary artery disease, obesity or high blood pressure. Patients with CLI often experience profound, chronic pain and develop decaying wounds or infections that lead to major limb amputation, an event closely associated with higher risk of death and reduced quality of life. To relieve the symptoms of CLI today, 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 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. Click here to view a video of how the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System works.
About LimFlow SA
LimFlow is a private, venture-backed medical device company transforming the treatment of Critical Limb Ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease and an aging population. For more information, visit www.limflow.com.
The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System is only available for investigational use in the USA and has not been approved for sale in the USA, Canada, or Japan.