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New Options

Clinical Evidence

Unprecedented clinical results for the most challenging patients

PROMISE I U.S. Early Feasibility Study Data

Amputation Free Survival at 24 Months
Limb Salvage at 24 Months
Wounds Healed or Healing at 24 Months
Results of the LimFlow System in the PROMISE I Trial (at 24 months). Presented at Vascular Interventional Advances Conference (VIVA), October 2021, Daniel Clair, MD.

LimFlow Clinical Program

150+ Patients Target

First-in-HumanPROMISE IALPS RegistryPROMISE InternationalPROMISE II U.S. Pivotal
# Centers1742020
# Patients7323250+60-120 (adaptive)
Primary EndpointMajor adverse limb and coronary eventsAFS at 6 monthsAFS at 6 monthsAFS at 6 monthsAFS at 6 months
ProtocolSingle-center, prospective, single-armMulti-center, prospective, single-armMulti-center, retrospectiveMulti-center, prospective, single-armMulti-center, prospective, efficacy and safety study
CountriesSingaporeU.S.Alkmaar, Leipzig, Paris, SingaporeUnited Kingdom, Europe, Singapore U.S., Japan
Secondary EndpointsAFS, wound healing, perfusionWound healing, patency, perfusionWound healing, patency, perfusionWound healing, patency, perfusion Wound healing, patency, perfusion
Total Length of Follow-up1 year2 years2 years1 year3 years