LimFlow Shows ‘PROMISE’ During VIVA
A firm that was labeled one of Medtechâs 16 Most Promising Private Companies by Canaccord Genuity earlier this year, has strong results from a study that will help with FDA approval. LimFlow recently announced positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the Percutaneous Deep Vein Arterialization (pDVA) System.
The Paris-based company presented the data during the Vascular Interventional Advances [VIVA] Conference held in Las Vegas, earlier this month. The companyâs technology is used for the treatment of chronic limb-threatening ischemia (CLTI). PROMISE I was conducted at seven U.S. centers encompassing 32 end-stage â or âno optionâ â CLTI patients, 100% of whom had non-healing wounds on the target foot, 69% of whom had diabetes, and 34% of whom had renal insufficiency.
At six months, the LimFlow System achieved an amputation-free survival rate of 74%. A strong trend of successful wound healing was also demonstrated, with 67% of wounds classified as healed or healing at six months and 100% healed or healing at nine months. Technical success was 97%.
âWeâre doing something very different,â Dan Rose, LimFlow, CEO told MD+DI. âWeâre channeling blood from the artery into the vein â taking out the valves in the veins...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news