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LimFlow news archives.

Nov 6 2020

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

Twelve-Month Results Presented Today in Late-Breaking Trials Session at Vascular Interventional Advances (VIVA) Conference

PARIS – November 6, 2020 — 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), today announced the presentation of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow Percutaneous Deep Vein Arterialization System, showing sustained positive outcomes for both amputation-free survival and complete wound healing. 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.

The 12-month results from the PROMISE I study show that 70 percent of patients achieved major amputation-free survival, similar to what was seen at six months, following treatment with the LimFlow System. The very challenging patients in the trial also had 75 percent of their wounds classified as healed or healing one year after treatment. Technical success was reported at 97 percent.

“One-year outcomes demonstrate that the benefits from treatment with the LimFlow System are durable,” said Dr. Clair. “One of the greatest challenges in the treatment of CLTI is to achieve long-lasting outcomes due to disease progression. In this study, the vast majority of patients who would otherwise be facing major amputation were able to avoid it and, at the same time, heal their previously non-healing wounds. This type of lasting result in such a challenging, no-option patient population offers tremendous hope to CLTI patients and the physicians who treat them.”

PROMISE I is a multi-center, prospective, single-arm study of the LimFlow System conducted at seven U.S. centers encompassing 32 end-stage – or “no option” – CLTI patients, 100 percent of whom had non-healing wounds on the target foot, 69 percent of whom had diabetes and 34 percent of whom had renal insufficiency. 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.

“We continue to be gratified about the number of patients in our clinical studies who are benefitting from the LimFlow System,” said LimFlow CEO Dan Rose. “Recognizing that most of these patients may have lost their limbs, and even their lives, without our technology drives all of us at the company, every day. We are excited about the clinical progress we are making and look forward to continuing to bring a better quality of life to patients who otherwise have little hope.”

The pivotal PROMISE II clinical trial of the LimFlow System is currently enrolling patients at centers across the U.S. Click here for more information about the trial.

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

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

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

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MEDIA CONTACT:

Michelle McAdam, Chronic Communications, Inc.
[email protected], +1 310-902-1274

May 19 2020

Publication of Two-Year Outcomes for LimFlow System Shows Excellent Amputation-free Survival and Wound Healing in Patients With No-Option Chronic Limb-Threatening Ischemia

Publication of Two-year Outcomes for LimFlow System Shows Excellent Amputation-free Survival and Wound Healing in Patients With No-option Chronic Limb-Threatening Ischemia

Multicenter, International ALPS Registry Outcomes Just Published in Journal of Endovascular Therapy

PARIS – May 19, 2020 — LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), the most severe form of peripheral artery disease (PAD), today announced publication of positive two-year data from the ALPS Registry of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. Results were published online yesterday in the Journal of Endovascular Therapy and will also appear in the August print issue of the journal. The ALPS Registry is the largest study to date of No-Option CLTI patients treated with the LimFlow System reporting mid- and long-term results.

“In this complex group of patients, pDVA using the LimFlow device has shown to be feasible and safe with high technical success and good amputation-free survival at six months up to 24 months coupled with good wound healing,” said the paper’s lead author, Andrej Schmidt, MD, Head of the Angiology CathLab at Leipzig University Hospital, Germany. “In selected patients with No-Option CLTI, pDVA is a safe and effective treatment to prevent amputation and heal wounds.”

“Patients with this disease suffer with chronic ulcers, often including gangrene, recurrent pain, and a very poor quality of life. CLTI is associated with poor mid- and long-term survival, and no-option patients often face the worst outcomes,” said Roberto Ferraresi, MD, Chief of the Peripheral Interventional Unit at the San Carlo Clinic, Milan, Italy, co-author of the paper, and a pioneer in the interventional treatment of CLTI. “These patients desperately need an option to avoid amputation and improve their life, and LimFlow offers a very promising alternative for them.”

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. All patients had non-healing wounds on the target foot and no arterial target for surgical or endovascular revascularization. Among them, 66 percent had diabetes, 53 percent had renal insufficiency, and 16 percent were dialysis dependent. The majority of patients had experienced failed prior attempts at revascularization.

The registry reported major amputation-free survival of 84 percent, 71 percent, and 67 percent, respectively, at six months, one year and two years. Additionally, a positive trend of successful wound healing was demonstrated, with 73 percent of wounds completely healed at two years. Technical success was 97 percent.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, 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. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing and prevents major amputation.

“It is very gratifying to see these durable results being demonstrated by the LimFlow System in a real-world setting with consecutive patients,” said LimFlow CEO Dan Rose. “For these no-option patients, the next intervention for their leg was going to be major amputation, with the associated morbidity and high mortality risk that comes with amputation. Instead, two years later, the vast majority of patients are alive, with almost three-quarters of them experiencing completely healed wounds. This registry adds to the building clinical evidence that LimFlow therapy is an effective solution for no-option patients.”

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

Click here to view a video of how the LimFlow System works.

About LimFlow SA

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

CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

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MEDIA CONTACT:
Michelle McAdam, Chronic Communications, Inc.
[email protected], +1 310-902-1274

Dec 10 2019

First Patient Enrolled in PROMISE II U.S. Pivotal Study of LimFlow System to Treat Chronic Limb-Threatening Ischemia

Clinical Study to Evaluate Device’s Ability to Prevent Amputation and Promote Wound Healing in Patients with No Other Options

PARIS – December 10, 2019 — 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 first patient has been treated in its PROMISE II U.S. pivotal trial of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. 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.

“We are pleased to be the first center in the country to treat a patient in this important trial,” said Dr. Archie. “The LimFlow System offers a promising new therapy with the potential to restore blood flow to the ischemic foot, heal wounds, and prevent major amputations in a patient population that today is unable to be treated with any current technology,”

PROMISE II is a multi-center, prospective, single-arm study being 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.

“Treating the first patient soon after FDA approval of the trial demonstrates the enthusiasm vascular specialists have for a therapy designed to help patients keep their limbs that would otherwise face amputation,” said LimFlow CEO Dan Rose. “With the increasing prevalence of diabetes, obesity and cardiovascular disease, CLTI has become a public health crisis, recognized by the FDA in designating the LimFlow system as a Breakthrough Device. We look forward to undertaking a rigorous study of our technology to offer new hope to patients who have no other options today.”

CLTI is the most severe form of PAD and often occurs in patients suffering from such conditions as coronary artery disease, diabetes, obesity, high cholesterol and 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.

Click here to view a video of how the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System works.

About LimFlow SA

MEDIA CONTACT:
Michelle McAdam, Chronic Communications, Inc.
[email protected], +1 310-902-1274

Nov 6 2019

LimFlow Announces Positive Six-month Data From PROMISE I U.S. Early Feasibility Study Demonstrating Excellent Amputation Free Survival and Wound Healing in No-option Patient Population

Results Presented Today at Vascular Interventional Advances (VIVA) Conference

PARIS – November 6, 2019 — 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), today announced the presentation of positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the LimFlow Percutaneous Deep Vein Arterialization System. Results were presented on the podium at the Vascular Interventional Advances Conference (VIVA) by Daniel Clair, MD, PROMISE II principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Palmetto Health-USC Medical Group.

“Findings from this early feasibility trial are very promising,” said Dr. Clair. “They show that the LimFlow System is a novel, safe and reproduceable approach for improving wound healing and reducing amputation rates in a patient population for whom amputation would otherwise be considered inevitable. It is very encouraging to be able to offer hope to patients that cannot be treated with any current technology today.”

PROMISE I is a multi-center, prospective, single-arm study conducted at seven U.S. centers encompassing 32 end-stage – or “no option” – CLTI patients, 100 percent of whom had non-healing wounds on the target foot, 69 percent of whom had diabetes, and 34 percent of whom had renal insufficiency.

At six months, the LimFlow System achieved an amputation-free survival rate of 74 percent. A strong trend of successful wound healing was also demonstrated, with 67 percent of wounds classified as healed or healing at six months and 100 percent healed or healing at nine months. Technical success was 97 percent.

“We are enthusiastic about the exceptional results for the LimFlow System,” said LimFlow CEO Dan Rose. “Our goal with the technology is to fully heal previously non-healing wounds and save more patients from amputation, improving their quality of life and preventing the downward spiral that comes from losing a limb. With the recent FDA approval of our pivotal trial, we look forward to shortly commencing enrollment in the U.S. and continuing to build evidence for the therapy.”

Click here to view a video of how the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System works.

About LimFlow SA

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MEDIA CONTACT:

Michelle McAdam, Chronic Communications, Inc.
[email protected], +1 310-902-1274

Sep 19 2019

Limflow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

PARIS – September 19, 2019 — 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 its Investigational Device Exemption for the PROMISE II pivotal study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.

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.

The approval to initiate the pivotal trial follows completion of six-month follow-up of the U.S. Early Feasibility Study – PROMISE I – that successfully enrolled 32 patients at seven centers. Interim outcomes from the first 10 patients treated in the PROMISE I study showed nine patients surviving and amputation-free at one year, with seven of these patients experiencing complete wound healing. These results were presented in May at the New Cardiovascular Horizons Conference by Steve Henao, MD, of the New Mexico Heart Institute. The complete results of PROMISE I will be presented during the Late Breaking Trials Session at the VIVA conference in Las Vegas in November.

“For these late-stage CLTI patients, success can be defined in two ways: wound healing and amputation-free survival. This exciting new therapy has the potential to restore blood flow to the ischemic foot, which may help patients heal their wounds and keep their feet. I am very encouraged by the early experiences in the U.S., and outcomes from this pivotal trial may offer hope to the many Americans who might otherwise face major amputations,” said Daniel Clair, MD, PROMISE II principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Palmetto Health-USC Medical Group.

“Major amputations have a devastating effect on the lives of patients and their families, and each one is a personal tragedy. Chronic Limb-Threatening Ischemia is a public health crisis and far too many limb amputations are performed in the world today, costing the healthcare system many billions of dollars,” said LimFlow CEO Dan Rose. “As part of the FDA Breakthrough Devices program, LimFlow is excited to commence its U.S. pivotal trial on the heels of the successful experience from the U.S. feasibility study. This is a tremendous milestone that furthers our mission of empowering vascular specialists to offer new hope to their CLTI patients who may be only days away from losing a limb.”

CLTI is the most severe form of PAD and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and high blood pressure, many of which are growing health problems. 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.

Click here to view a video of how the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System works.

About LimFlow SA

###

MEDIA CONTACT:

Michelle McAdam, Chronic Communications, Inc.
[email protected], +1 310-902-1274