Skip to content
New Options

Clinical Evidence

Unprecedented clinical results for the most challenging patients

PROMISE II U.S. Pivotal Trial at 6 Months

Limb Salvage*

Functional Limb Preservation in No-Option Patients

Wounds Healed or Healing*

Wound Healing in Patients With Non-Healing Chronic Wounds

*Results of the LimFlow System in the PROMISE II US Pivotal Trial (at 6 months).
Shishehbor, M et al. Transcatheter arterialization of deep veins in chronic limb-threatening ischemia. N Engl J Med, 2023; 388, 1171–1180.

See LimFlow’s article, ‘Transcatheter Arterialization of Deep Veins in
Chronic Limb-Threatening Ischemia’ in NEJM.

LimFlow Clinical Program

First-in-HumanPROMISE IALPS RegistryPROMISE International & UKPROMISE II U.S. PivotalPROMISE III
# Centers1741610525
# Patients732326260-120 (adaptive)100
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