“LimFlow recently presented compelling 12-month data from its PROMISE I US feasibility study at the VIVA conference, which demonstrated amputation free survival of 70%, limb salvage of 77%, and survival of 91% at 12 months,” explains LimFlow CEO Dan Rose.

As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews LimFlow CEO Dan Rose.

A 45-year-old woman recently shared her story with me after finding our patient advocacy nonprofit The Way To My Heart and wishing she had found it sooner because we may have helped her save not just one leg but both. Two months after being diagnosed with Peripheral Artery Disease, a narrowing of mainly the leg arteries due to plaque build-up, her hospital vascular specialist told her that the vessels below her knee were severely compromised and too small to treat. He told her to walk until she couldn’t walk anymore and then he would amputate.

One night about six months later, she woke up at 2am because the pain was unbearable and she decided it was her leg or life. So, she and her husband drove to the emergency room where physicians pumped her full of powerful pain medications until her surgeon arrived and took her to the operating room to amputate her leg at the knee. She had never thought to get a second opinion as her vascular specialist was the head of the department at a large University Hospital. She thought he was the best and didn’t think to question his skillset until he gave her the same option for her left leg one year later. That’s when she found The Way To My Heart and we directed her to a “Pedal Loop Specialist” trained in navigating the small blood vessels below-the-knee to restore flow.

This woman’s story is not unique. Nearly 200,000 needless amputations are performed annually due to advanced stages of PAD, known as Critical Limb Threatening Ischemia. Navigating smaller, compromised vessels below-the-knee is risky and requires highly skilled interventionalists, special tools, and additional time, which are few and far between. New technology has the potential to change that. LimFlow has formalized a technique used by advanced interventionalists to re-route blood flow around a blockage in an artery below-the-knee using a vein. Arteries naturally deliver blood flow to the foot and veins are responsible for outflow. LimFlow’s system includes a specially designed crossing device to easily make the artery to vein connection. Forward flow is enabled in the vein through a disabling of the venous valves using a valvulotome. An extension stent is placed to block smaller veins from taking blood flow in the newly converted vein back to the heart, and a tapered crossing stent is used to bridge the artery to vein connection.

LimFlow’s CEO Dan Rose shares the backstory behind the system, which has already received CE Mark for use in Europe, and is well on it’s path to U.S. FDA clearance in the Q&A below.

What is the story behind the technology? Where did it originate?

LimFlow was one of the first companies to come out of the Paris-based medical device accelerator MD Start when it was founded in 2012. The idea for the LimFlow System came from interventional cardiologist Martin Rothman, MD, former VP of Medical Affairs for Medtronic Vascular, and previously an interventional cardiologist at Barts Health in London, UK. Having been inspired by the concept of cardiac venous arterialization, he sought to create a reliable revascularization technique for CLTI patients who had no-option for further surgical or endovascular revascularization. MD Start helped found LimFlow based on Rothman’s original development work, with Tim Lenihan from MD Start as acting CEO. After completing preclinical studies, Lenihan and Rothman enlisted Steven Kum, MD, a Vascular and Endovascular Surgeon at the Changi General Hospital in Singapore who led a seven-patient pilot study in “no option” CLTI patients. The results were promising: 100% procedural success, no deaths at 30 days, complete wound healing in four patients at six months (and five at 12 months), and limb salvage rates of 85.8% at six months and 68.5% at 12 months. These encouraging results were achieved in people who were classified as “high risk” patients using the WIfI (Wound Ischemia foot Infection) clinical classification and were facing certain amputation within a one-year timeframe. The positive results of this initial study led to the initiation of the PROMISE I US feasibility study and LimFlow earning CE Mark in 2016. LimFlow recently presented 12-month data from the PROMISE I study at the VIVA conference and is currently enrolling patients in the PROMISE II US pivotal study.

What need does it address?

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. These “no-option” patients face the prospects a major lower limb amputation.

What is the potential for patient impact?

LimFlow is a minimally-invasive technology designed to divert blood around diseased arteries in the leg and into the tibial veins that feed the foot, bringing blood and oxygen to starved tissues in the foot. An abundance of oxygen in the tissue can relieve pain and promote healing of chronic wounds for many patients, improving their quality of life and getting them back to the things they love.

One patient that stands out is our first in Ohio. Cynthia, a Type 1 Diabetic had her left leg amputated and she entered our study hoping we could save her right leg. She told a local TV station covering our study, “I can’t imagine not having both legs…It’s bad enough not having one.” The procedure restored flow and the patient’s leg was saved. Her case is not unique.

Where is the technology in development and what is next for the company?

LimFlow recently presented compelling 12 month data from its PROMISE I US feasibility study at the VIVA conference which demonstrated amputation free survival of 70%, limb salvage of 77%, and survival of 91% at 12 months. LimFlow is currently enrolling patients in the PROMISE II US pivotal trial at centers through the US. 

How can patients or advocates get involved?

The focus currently is on completing enrollment in the PROMISE II Trial. There are several active sites across the US that are currently enrolling patients, and you can visit our US Clinical Trial website to learn more about the trial and see the list of active sites near you. If you are facing amputation due to CLTI, the PROMISE II study may offer you an alternative a treatment option.