November 6, 2020
Safety and Efficacy of LimFlow’s pDVA System Evaluated in PROMISE I Trial
November 6, 2020—Daniel Clair, MD, presented findings from the multicenter PROMISE I trial of the first human use in the United States of the LimFlow system (LimFlow SA), a purpose-built percutaneous deep vein arterialization (pDVA) device for the treatment of no-option chronic limb-threatening ischemia (CLTI) patients.
The LimFlow procedure permanently bypasses unreconstructible arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot. The purpose of the trial is to establish safety, effectiveness, and feasibility of the LimFlow system for use in the treatment of CLTI.
The PROMISE I results were presented by Dr. Clair in a late-breaking clinical trials session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress on November 6-8, 2020.
As summarized in the VIVA press release, 32 no-option CLTI patients (mean age, 71 ± 14 years; 66% men) were enrolled in a nonrandomized manner at seven centers across the United States. All patients had Rutherford 5 or 6 class disease and deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow. Patients underwent percutaneous deep vein arterialization using the LimFlow system.
The primary safety endpoint was above-ankle amputation-free survival (AFS) at 30 days, with a secondary endpoint of AFS at 6 months. Other secondary endpoints included technical success, vessel patency, and wound healing.
The technical success of the LimFlow procedure was 97%, with only one technical failure. The primary safety endpoint of amputation-free survival (AFS) at 30 days was 91%. The secondary endpoint of AFS at 12 months was achieved in 70%. Core lab–adjudicated wound healing categorized 75% of wounds as healed or healing.
Dr. Clair discussed the trial and results with Endovascular Today.
“The PROMISE I 12-month data represent the early experience with a purpose-built technology to perform percutaneous deep vein arterialization in a group of patients with no percutaneous or surgical revascularization option,” stated Dr. Clair.
“This particular group of patients was heavily scrutinized with an independent review board confirming the absence of standard revascularization options and over 90% felt to have only major amputation as alternatives to this technique. Over 70% of these patients had amputation free survival out to 1 year, and there were lessons learned from this initial experience to help advance the therapy moving forward and we are implementing changes these findings exemplified in the PROMISE II trial as we continue to gain experience with this technology and this technique.
“Clearly deep vein arterialization with this equipment is safe and feasible and has proven valuable over an extended period of time in saving limbs in these patients at critical risk of limb loss,” concluded Dr. Clair.
In December 2019, LimFlow announced the commencement of PROMISE II, which is the company’s United States pivotal trial of the LimFlow pDVA system for the treatment of CLTI. The multicenter, prospective, single-arm PROMISE II study is being conducted in the United States and Japan.