Unprecedented clinical results for the most challenging patients
PROMISE II U.S. Pivotal Trial at 6 Months
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 Results
LimFlow Clinical Program
|First-in-Human||PROMISE I||ALPS Registry||PROMISE International & UK||PROMISE II U.S. Pivotal||PROMISE III|
|# Patients||7||32||32||62||60-120 (adaptive)||100|
|Primary Endpoint||Major adverse limb and coronary events||AFS at 6 months||AFS at 6 months||AFS at 12 months||AFS at 6 months||AFS at 6 months|
|Protocol||Single-center, prospective||Multi-center, prospective||Multi-center, retrospective||Multi-center, prospective||Multi-center, prospective, efficacy and safety study||Multi-center, prospective|
|Countries||Singapore||U.S.||Alkmaar, Leipzig, Paris, Singapore||UK, Germany, Netherlands, Singapore, New Zealand||U.S.||U.S.|
|Secondary Endpoints||AFS, wound healing, perfusion||Wound healing, patency, perfusion||Wound healing, patency, perfusion||Wound healing, patency, perfusion||Wound healing, patency, perfusion||Wound healing, patency, perfusion|
|Total Length of Follow-up||1 year||2 years||2 years||1 year||3 years||3 years|