Paris-based LimFlow’s results came from its Promise II U.S. pivotal trial. They were published in today’s issue of the New England Journal of Medicine (NEJM). Data demonstrated 66% amputation-free survival at six months with the LimFlow system.
This exceeded the FDA’s performance goal with statistical significance, LimFlow said in a news release.
LimFlow designed its TADV (transcatheter arterialization of deep veins) system to reestablish blood flow in deep veins. It treats “no-option” CLTI patients who exhausted all other treatment methods. These patients face major amputations of their lower limbs. The therapy aims to prevent amputation and the associated complications, mortality and deterioration of quality of life.
This minimally invasive system bypasses blocked arteries in the leg and delivers oxygenated blood back into the foot through the veins.
Mehdi Shishehbor, co-principal investigator and president of the Harrington Heart and Vascular Institute, University Hospitals, said the study’s publication “reinforces the transformational value of TADV” for this patient population. Shishehbor served as lead author of the NEJM paper.
“The introduction of this therapy provides the possibility of limb salvage for a no-option CLTI population previously consigned to primary amputation, potentially reducing the suffering, mortality, and economic burden in this ever-growing segment of patients,” Shishehbor said.
Dr. Daniel Clair, the co-principal investigator, added that results establish TADV as a legitimate alternative to amputation for these patients. Clair serves as professor and chair of the department of vascular surgery at Vanderbilt University Medical Center Section of Surgical Sciences.
More on the LimFlow study
Promise II evaluated the most severe CLTI patient group ever in a vascular device pivotal trial, LimFlow said. All patients suffered from end-stage peripheral artery disease (PAD). Additionally, 77% suffered from diabetes, and 57% reported chronic kidney disease. Many of the latter were on dialysis.
The multi-center, single-arm study evaluated 105 no-option CLTI patients across 20 U.S. sites. It aimed for diversity in its patient population. People who identify as Black, Hispanic or Latino made up 43% of subjects. Female subjects made up 31% of the cohort. The study aims to follow its subjects for out to three years.
Promise II demonstrated a 76% limb salvage rate. More than three quarters of patients kept their leg and avoided amputation. Additionally, 76% of patients demonstrated completely healed wounds (25%) or wounds in the process of healing (51%). Patients reported substantially reduced pain. Pain scores dropped from 5.3/10 before treatment to 3/10 at six months. LimFlow also reported 99% technical success for the procedure. This indicates a reproducible procedure across diverse sites and investigators.
“Too often, patients are confronted with the limits of traditional interventional options and must undergo a major amputation, which often leads to severe complications, greatly reduced quality of life, and an early death. The LimFlow System demonstrated remarkable success in relieving patients’ pain and healing their wounds, diverting them from amputation and putting them on a path towards a better life,” said LimFlow CEO Dan Rose. “We want to thank the clinical investigators and their research teams for their commitment to this important research. As this is a large and growing patient population in great need of a new therapeutic option, we look forward to engaging further with the FDA as we seek regulatory approval.”