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Clinical Evidence

Unprecedented clinical results for the most challenging patients

PROMISE I U.S. Early Feasibility Study Data

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 International & UKPROMISE II U.S. PivotalPROMISE III
# Centers1741610525
# Patients732326260-120 (adaptive)100
EnrollmentCompleteCompleteCompleteCompleteCompleteOngoing
Primary EndpointMajor adverse limb and coronary eventsAFS at 6 monthsAFS at 6 monthsAFS at 12 monthsAFS at 6 monthsAFS at 6 months
ProtocolSingle-center, prospectiveMulti-center, prospectiveMulti-center, retrospectiveMulti-center, prospectiveMulti-center, prospective, efficacy and safety studyMulti-center, prospective
CountriesSingaporeU.S.Alkmaar, Leipzig, Paris, SingaporeUK, Germany, Netherlands, Singapore, New ZealandU.S.U.S.
Secondary EndpointsAFS, wound healing, perfusionWound healing, patency, perfusionWound healing, patency, perfusionWound healing, patency, perfusion Wound healing, patency, perfusionWound healing, patency, perfusion
Total Length of Follow-up1 year2 years2 years1 year3 years3 years