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pDVA System

LimFlow completes enrolment In US Study assessing pDVA System

Novel technology is designed to restore blood flow to ischemic lower limbs, which may resolve pain, help wounds heal and avoid major amputation

LimFlow has completed enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. The company also announced that the 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 US subjects and six US institutions.

The LimFlow device is a novel and purely percutaneous therapy for ‘no-option’ critical limb ischaemia patients when all other revascularisation efforts have been exhausted and a patient is facing a major amputation. The 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 vascularise the foot. Achieving tissue perfusion may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients.

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.

 “This is the biggest advance I've seen for people at risk of amputation in my 25 years in practice,” said Dr Daniel Clair, 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. “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.”

“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 recognises the novelty of our system and the promise it holds in treating the epidemic of critical limb ischemia. Over 100,000 patients in the US 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 US patients with no good options today.”

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.