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LimFlow System Demonstrates Excellent Sustained Amputation-free Survival and Wound Healing at 1 Year in PROMISE I U.S. Study

LimFlow notes the results were presented in the Late-Breaking Data session at the VIVA Conference by Daniel Clair, MD, PROMISE I principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Prisma Health-USC Medical Group.

Positive Two-Year Data from the ALPS Registry of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System

The ALPS Registry is a multi-center, retrospective study conducted at centers in Alkmaar, Netherlands; Leipzig, Germany; Paris; and Singapore encompassing 32 end-stage – or “no-option” – CLTI patients.

pDVA Experts Panel Video Discussion

In this video, watch as Dr. Roberto Ferraresi, Cardiologist, Humanitas University and Director, Interventional Peripheral Unit, Humanitas...

LimFlow Reports First Patient Enrolled in PROMISE II U.S. Pivotal Study

The successful first case was performed by Mark Archie, MD, principal investigator for the PROMISE II trial at Harbor-UCLA Medical Center, and Nina Bowens, MD, sub-investigator for the PROMISE II trial at Harbor-UCLA Medical Center.

LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology

PROMISE II is a multi-center, prospective, single-arm study to be conducted in the U.S. and Japan. Using an adaptive statistical design, the study plans to enroll 60 to 120 “no option” CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, and subjects will be followed out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.

LimbFlow Announces First Patient Treated in U.S. Feasibility Study and Commencement of International Post-Market Study

LimbFlow reports this clinical trial is the initial step towards a U.S. approval pathway for the LimFlow System.

LimFlow Receives FDA Approval for U.S. Feasibility Study of Minimally-Invasive Technology Designed to Restore Perfusion in “No Option” Critical Limb Ischemia Patients

When all other therapeutic options have been exhausted and a CLI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and rush oxygenated blood back into the foot.