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PROMISE I – U.S. Feasibility Study

PROMISE I is a multi-center, prospective, single-arm study conducted at seven U.S. centers encompassing end-stage — or “no option” — CLTI patients. All patients were confirmed as “No-Option” and facing imminent amputation by an independent review committee of vascular surgeons. Patients were enrolled between July 2017 and April 2019.

Patient Demographics

32 Patients

PROMISE I - Demographics | amCharts

PROMISE I Study Results – OUS
Rutherford class 5 or 6
Ineligible for endovascular or surgical procedures to restore blood flow

24-Month Outcomes1

N=31

PROMISE I - Primary Endpoint Amputation Free Survival | amCharts

6 Months

AFS = 74%
Survival = 96%
FFA = 77%

12 Months

AFS = 70%
Survival = 91%
FFA = 77%

24 Months

AFS = 59%
Survival = 77%
FFA = 77%

Technical Success
Complete Wound Healing

Watch the 2-Year PROMISE I Presentation
with Dan Clair, MD from VIVA 2021

Watch interview with PROMISE I PI Dan Clair, MD

1. Clair, Dan. “Results of the LimFlow System in the Promise I Trial” Vascular Interventional Advances Conference”. November 2021, The Wynn Las Vegas. Late Breaking Clinical Trial Presentation.