LimFlow System for TADV in CLTI Evaluated at 1 Year in PROMISE II Pivotal Trial

October 31, 2023—The 1-year results of the multicenter PROMISE II pivotal trial of the purpose-built LimFlow system (LimFlow, Inc.) for transcatheter arterialization of deep veins (TADV) evaluated the device in the treatment of patients with no-option chronic limb-threatening ischemia (CLTI) patients.

The findings from the investigational device exemption trial were presented by Daniel Clair, MD, during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

As noted in the VIVA press release, no-option CLTI presents with a disease state so complex that currently available surgical and endovascular techniques are not sufficient, and major amputation is considered the only solution. The TADV procedure permanently bypasses unreconstructible arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot.

In the study, 105 no-option CLTI patients were enrolled in a nonrandomized manner at 20 centers without roll-ins across the United States. All enrolled patients had Rutherford class 5 or 6 disease and were deemed by an independent committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow.

The patients underwent TADV using the LimFlow system. The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino. Most patients presented with preexisting comorbidities, including diabetes, hypertension, dyslipidemia, and a history of intervention on the index limb. All patients presented with a nonhealing ulcer or frank gangrene and were classified as either Rutherford class 5 or 6.

As reported at VIVA, the study at 1 year showed limb salvage was maintained in 69% of patients, the average wound area was 0.2 cm², and the average pain score (scale, 0-10) was 1.4. More than half of patients were classified as Rutherford class 0 at 1 year.

The 1-year results of PROMISE II demonstrate durability of outcomes of the TADV procedure using the LimFlow system and that the procedure is safe and reproducible, concluded the study.