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 Results
LimFlow Clinical Program
| First-in-Human | PROMISE I | ALPS Registry | PROMISE International & UK | PROMISE II U.S. Pivotal | PROMISE III | |
|---|---|---|---|---|---|---|
| # Centers | 1 | 7 | 4 | 16 | 105 | 25 |
| # Patients | 7 | 32 | 32 | 62 | 60-120 (adaptive) | 100 |
| Enrollment | Complete | Complete | Complete | Complete | Complete | Ongoing |
| 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 |