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FDA APPROVES LIMFLOW SYSTEM IN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA AND NO SUITABLE ENDOVASCULAR OR SURGICAL REVASCULARIZATION OPTIONS

New Therapeutic Option Has Potential to Reduce Rate of Major Limb Amputation in U.S.

PARIS AND SAN JOSE, CALIF. – 09/12/2023 — LimFlow SA, a 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), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation.

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients. The therapy is designed to save patients’ legs from major amputation, as limb loss is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans1 and disproportionately impacts minority and underserved patients,2 resulting in more than 150,000 major amputations per year in the U.S.3 FDA approval of the LimFlow System will enable these patients to have access to a minimally invasive treatment giving them a chance to save their limbs and improve their quality of life.

“With LimFlow, we now have an option for the sickest patients who were previously consigned to limb loss and the downward spiral that accompanies it,” said Daniel Clair, MD, PROMISE II/III Co-Principal Investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “Using this new treatment, we have seen many patients whose limbs have been saved, whose pain has been reduced or resolved, whose chronic wounds are healed or healing, and who can now look forward to happier and more active lives.”

FDA approval was based on successful outcomes seen in the PROMISE II pivotal trial, recently published in The New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment.4

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

“At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI. We developed a novel way to make a vein function as an artery with the goal of saving limbs, and by doing that, saving patients’ lives,” said LimFlow CEO Dan Rose. “We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

The LimFlow System is indicated for patients who have chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in Canada or Japan.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from diabetes, coronary artery disease, 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.

About LimFlow and the LimFlow System

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally invasive LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins. Restoring perfusion in the lower limbs may help resolve chronic pain, improve quality of life, enable wound healing, and prevent major amputation. Click here to view a video of how the LimFlow System for TADV works.

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population. For more information, visit www.limflow.com.

  1. Yost ML. CLI U.S. epidemiology supplement 2016. THE SAGE GROUP.
  2. Kalbaugh CA, Witrick B, Sivaraj LB et al. Non‐Hispanic Black and Hispanic Patients Have Worse Outcomes Than White Patients Within Similar Stages of Peripheral Artery Disease. JAHA.2022 Jan 4;11(1): https://doi.org/10.1161/JAHA.121.023396.
  3. Creager MA, Matsushita K, Arya S, Beckman JA, Duval S, Goodney PP, Gutierrez JAT, Kaufman JA, Joynt Maddox KE, Pollak AW, Pradhan AD, Whitsel LP. Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association. Circulation. 2021 Apr 27;143(17):e875-e891.
  4. Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180.

MEDIA CONTACTS:
Tim Baker, for Chronic Communications Inc.
Tim.baker@mrnacommunications.com, +1 919-969-3492

Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274

LANDMARK NEW ENGLAND JOURNAL OF MEDICINE PUBLICATION REPORTS POSITIVE RESULTS FROM PROMISE II PIVOTAL TRIAL SHOWING THAT LIMFLOW SYSTEM SAVES MOST PATIENTS WITH END-STAGE PERIPHERAL ARTERY DISEASE FROM MAJOR AMPUTATION

  • PROMISE II Trial Met Primary Endpoint
  • Therapy Demonstrates 76% Limb Salvage in Patients with Chronic Limb-Threatening Ischemia Who Otherwise Faced Amputation

PARIS – March 30, 2023 — LimFlow SA, a 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), announced today that results from the PROMISE II U.S. pivotal trial were published in today’s issue of the New England Journal of Medicine (NEJM). The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months. This exceeded the FDA’s Performance Goal with statistical significance.

The LimFlow System for TADV (Transcatheter Arterialization of Deep Veins) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients who have exhausted all other treatment methods and face major amputation of their lower limb. The therapy is designed to prevent amputation, which is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans and disproportionately impacts minority and underserved patients, resulting in more than 150,000 major amputations per year in the U.S.

“The publication of PROMISE II in the New England Journal of Medicine reinforces the transformational value of TADV for a patient population in great need,” stated Mehdi Shishehbor, DO, MPH, PhD, PROMISE II Co-Principal Investigator, President of the Harrington Heart and Vascular Institute, University Hospitals, and lead author of the NEJM paper. “The introduction of this therapy provides the possibility of limb salvage for a no-option CLTI population previously consigned to primary amputation, potentially reducing the suffering, mortality, and economic burden in this ever-growing segment of patients.” “These results establish TADV as a real alternative to major amputation for patients facing inevitable limb loss from no-option CLTI,” said Daniel Clair, MD, PROMISE II Co-Principal Investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “This therapy will enable us to redefine the concept of a ‘no-option’ CLTI patient by giving us a treatment that offers patients limb salvage and hope.”

The PROMISE II Trial also demonstrated:

  • 76% limb salvage rate, where more than three-quarters of patients kept their leg and avoided amputation
  • 76% of patients had wounds that were completely healed (25%) or in the process of healing (51%)
  • Patient pain was substantially reduced, with average pain scores dropping from 5.3/10 prior to treatment to 3.0/10 six months after treatment
  • 99% technical success of the procedure, indicating a reproducible procedure across diverse sites and investigators

PROMISE II is a landmark trial of the most severe CLTI patient group ever studied in a vascular device pivotal trial, with 100% of patients suffering from end-stage peripheral artery disease (classified as Rutherford Stage 5 or 6), 77% with diabetes, and 57% with chronic kidney disease, many of whom were on dialysis. The multi-center, prospective, single-arm study encompassed 105 no-option CLTI patients treated at 20 U.S. sites. PROMISE II was designed to be representative of a broad patient population, with 43% of subjects being Black, Hispanic, or Latino, and 31% female. Subjects will be followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat their CLTI.

“Too often, patients are confronted with the limits of traditional interventional options and must undergo a major amputation, which often leads to severe complications, greatly reduced quality of life, and an early death. The LimFlow System demonstrated remarkable success in relieving patients’ pain and healing their wounds, diverting them from amputation and putting them on a path towards a better life,” said LimFlow CEO Dan Rose. “We want to thank the clinical investigators and their research teams for their commitment to this important research. As this is a large and growing patient population in great need of a new therapeutic option, we look forward to engaging further with the FDA as we seek regulatory approval.”

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.
Follow us on: LinkedIn, Facebook and Twitter.

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

MEDIA CONTACT:

Michelle McAdam, Chronic Communications Inc.

michelle@chronic-comm.com, +1 310-902-1274

LATE-BREAKING DATA FROM PROMISE I STUDY ON LIMFLOW SYSTEM CONFIRM EXCELLENT SUSTAINED OUTCOMES IN PATIENTS WITH NO-OPTION CHRONIC LIMB-THREATENING ISCHEMIA

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 – 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.
Follow us on: LinkedIn, Facebook and Twitter.

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 – 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.
Follow us on: LinkedIn, Facebook and Twitter.