Limb salvage in 77 percent of patients at 2 years with “no-option” for revascularization via traditional techniques
24-Month Results Presented Wednesday at VIVA 2021 Conference
SAN JOSE, Calif. and LAS VEGAS, Oct. 7, 2021 /PRNewswire/ — LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), on Wednesday announced 24-month results from the PROMISE I Study of the LimFlow Percutaneous Deep Vein Arterialization System (“LimFlow System”), confirming excellent and sustained outcomes for both amputation-free survival and wound healing. The late-breaking data was presented on Wednesday at the Vascular Interventional Advances (VIVA) Conference in Las Vegas, Nevada.
“The presentation of the PROMISE I 24-month results validate the benefits of the LimFlow System,” said Daniel Clair, MD, PROMISE I principal investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “The high percentage of no-option CLTI patients that remained amputation free at 24-months is a major positive step forward for a condition characterized by high amputation and mortality rates.”
PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System, conducted at seven study centers across the U.S. All of the 32 patients enrolled in the study had non-healing wounds on the target foot. The primary endpoints were freedom from amputation (FFA), amputation-free survival (AFS), and survival overall. There were no amputations after day 75 in the study. At 24-months, FFA remained at 77 percent with an AFS of 59 percent. Three additional deaths within the second year of study resulted in 77 percent survival (two non-limb-related deaths; one from sepsis due to a non-healing wound in the non-treated foot). 92 percent had all wounds classified as healed or healing as adjudicated by an independent core lab. Technical success was reported at 97 percent.
“The 2-Year data from PROMISE I US feasibility study is highly encouraging and sends a strong signal about the potential of the LimFlow System to strengthen our mission of no limb left behind,” said LimFlow CEO Dan Rose. “We are swiftly advancing our study of the LimFlow System in the ongoing PROMISE II US pivotal study in a patient population which is facing a very poor overall prognosis in terms of mortality and quality of life after major limb amputation. The LimFlow System is designed to help heal wounds and avoid major limb amputation, and we are proud of our mission of ‘No Limb Left Behind.'”
About Chronic Limb-Threatening Ischemia (CLTI)
CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.
No-option CLTI is defined as being ineligible for surgical or endovascular arterial revascularization as adjudicated by an independent committee of vascular surgeons
About LimFlow and the LimFlow System
LimFlow SA is a private, venture-backed medical device company, transforming the treatment of CLTI, a severe condition, for which there is a growing clinical need in light of high mortality rates. The minimally-invasive LimFlow System is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in CLTI patients who are facing major amputation and have exhausted all other therapeutic options.
The LimFlow System received the Conformitè Europëenne (CE) Mark in October 2016 and is currently only commercially available in Europe. The PROMISE II study is currently enrolling patients at up to across 22 sites in the U.S. and Japan. For more information, please visit: add link.
For more information on LimFlow and the LimFlow System, please visit www.limflow.com.
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