French firm LimFlow has begun patient enrolment for a feasibility study of its Percutaneous Deep Vein Arterialisation (pDVA) system to treat patients with end-stage critical limb ischemia (CLI) in the US.
Featuring ultrasound-guided catheters and nitinol stents, the LimFlow System bypasses diseased arteries and redirects blood flow into the tibial vein for vascularising the ischemic foot.
When the system is used as part of a multi-disciplinary team approach, the restoration of perfusion is expected to mitigate rest pain, enhance chronic wound healing, minimise major amputations, and restore mobility.
To be led by the University of Michigan Health’s Dr Jihad Mustapha, the multi-centre, prospective, single-arm feasibility study will enrol ten patients who have exhausted all other revascularisation options.
Mustapha said: “Because of the mortality rate associated with amputations due to ischemia, 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.”
With a follow-up period of two years, the study will be conducted at three sites in the country and will evaluate several endpoints, including amputation-free survival at one month, patency, limb salvage, and wound healing.
LimFlow has also commenced a multi-centre, prospective, single-arm, post-market surveillance study to be performed in approximately 50 Rutherford class 5 and 6 no-option Asian and European subjects with CLI.
The endpoints of this study are amputation-free survival (AFS) and wound healing progression, while the follow-up duration is one year.