Feasibility Trial of LimFlow's Percutaneous Deep Vein Arterialization System Completes Enrollment
January 29, 2018—LimFlow SA, a developer of technology for the treatment of end-stage critical limb ischemia (CLI), announced completion of enrollment in the original 10-patient cohort in the United States feasibility study of the company's LimFlow percutaneous deep vein arterialization (pDVA) system. Commencement of enrollment was announced in July 2017.
The company also announced that the US 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, for a total number of 25 patients enrolled at six institutions in the United States.
According to the company, the LimFlow pDVA 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. The system uses the company's ultrasound-guided catheters and covered nitinol stents, which are 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.
In the company's press release, Daniel Clair, MD, commented, "This is the biggest advance I've seen for people at risk of amputation in my 25 years in practice. 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." Dr. Clair, who performed the 10th case in the feasibility study on January 25, serves as Chair of the Department of Surgery at the University of South Carolina and the Palmetto Health-USC Medical Group in Columbia, South Carolina.
The FDA also accepted the LimFlow system into its Breakthrough Device Program, a designation previously known as the Expedited Access Pathway. 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 pDVA system received CE Mark approval in October 2016 and is currently available commercially in Europe. In the United States, the LimFlow system is only available for investigational use. It has not been approved for sale in the United States, Canada, or Japan, advised the company.