LimFlow SA has announced enrolment of the first patient in the US feasibility study of the LimFlow percutaneous deep vein arterialisation (pDVA) system, a novel, purely percutaneous device for the treatment of end-stage critical limb ischaemia (CLI) when all other revascularisation efforts have been exhausted. The first patient was treated on 5 July at Metro Health–University of Michigan Health, Wyoming, USA, by Jihad A Mustapha.
The feasibility study is a multicentre, prospective, single-arm study to be conducted at three US centres encompassing 10 “no-option” CLI patients. Endpoints include amputation-free survival at one month, patency, limb salvage and wound healing. Subjects will be followed out to two years. This clinical trial is the initial step towards a US approval pathway for the LimFlow system.
“The only other disease with worse life expectancy than CLI is pancreatic cancer. Because of the mortality rate associated with amputations due to ischaemia, a new approach to treat CLI is needed now more than ever. In the LimFlow study, we hope to help patients with no other options that are on their way to amputation,” said Mustapha, the study’s primary investigator.
The Paris-based medical device company also announced the initiation of a multicentre, prospective, single-arm post-market surveillance study, which will enrol up to 50 Rutherford class 5 and 6 “no-option” patients in several CLI centres of excellence in Europe and Asia. Patients will be followed out to one year, and endpoints include amputation-free survival and wound healing progression. Data collection is aligned with the US feasibility study, allowing for a large comparable data set for the use of the LimFlow system in this “no-option” CLI sub-group.
The LimFlow system is designed to restore perfusion to the ischaemic 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. It uses proprietary ultrasound-guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein to vascularise the ischaemic foot.
“With approximately 150,000 ischaemic amputations annually in the USA costing the healthcare system many, many billions of dollars, we look forward to further exploring the promise of LimFlow and its role in treating the epidemic of CLI,” said LimFlow chief executive officer Dan Rose.