LimFlow SA

09/12/2023

We’re excited to announce that the FDA has approved our LimFlow System for the treatment of people with severe artery disease (known as Chronic Limb-Threatening Ischemia) who are facing amputation of their foot or lower leg. LimFlow is designed to restore blood flow to your foot, with the goal of saving your leg, relieving pain, promoting wound healing, and providing hope for a better life.
Learn more: https://www.businesswire.com/news/home/20230908213065/en/FDA-Approves-LimFlow-System-in-Patients-With-Chronic-Limb-Threatening-Ischemia-and-No-Suitable-Endovascular-or-Surgical-Revascularization-Options #:~:text=PARIS%20%26%20SAN%20JOSE%2C%20Calif.,FDA)%20has%20approved%20the%20LimFlow

04/02/2023

Just in time for Limb Loss Awareness Month, our US pivotal trial results were published in the New England Journal of Medicine.
Six-month results showed:
•76% limb salvage
•76% of wounds were completely healed (25%) or healing (51%)
•Substantial pain reduction
•99% technical success

01/13/2022

With the cost of healthcare continually rising, it is essential to keep patients healthier and more independent. As such, reducing amputation rates is essential for the economics of the healthcare sector. Not only would lowering the limb amputation rate decrease medical spending, but it would also improve patient quality of life.

“Amputation and the loss of an ability to ambulate often changes living situations, family situations, and the ability of an individual to take care of themselves,” explains Dan Clair, MD Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center, in an interview with Joe Mullings, Chairman of the Board of TMG360 Media. “There’s a huge cost to caring for these patients beyond that initial procedure.”

The goal of LimFlow SA’s technology and the percutaneous Deep Vein Arterialization procedure is to keep these patients functional and keep healthcare expenses low for society as a whole.

Watch the full interview with Dr. Clair, Dan Rose, and Joe Mullings here https://youtu.be/GJjklWEC328.

With the cost of healthcare continually rising, it is essential to keep patients healthier and more independent. As such, reducing amputation rates is essent...

01/10/2022

Recently, Dan Rose, CEO of LimFlow SA sat down with Dave Philistin, CEO of Candor to discuss the LimFlow technology and the positive impact it could have on our wellness.

Read more about LimFlow’s technology here:

An Interview With Dave Philistin

01/05/2022

The LimFlow PROMISE I Study included subjects with no option for further surgical or endovascular revascularization, making them one of the most complex groups ever studied. In prior studies, there was no significant limb salvage enhancement in these patients. Within the PROMISE I study, the FDA required LimFlow to utilize a separate independent group of vascular surgeons to evaluate patient history to make sure that these patients had exhausted all traditional limb salvage options.

Dan Clair, MD, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center and Principal Investigator for the PROMISE II Pivotal Trial, discussed this study with Joe Mullings, Chairman of the Board of TMG360 Media.

“These were clearly patients who could not have anything other than this done,” Clair explained. “I think it’s good that the FDA did that because they provided us with a very clearly defined group of patients who go into this trial. They’re probably the sickest group of patients that have ever been enrolled in a trial to try and study limb salvage.”

Watch the full interview with Dr. Clair, Dan Rose, and Joe Mullings here https://youtu.be/hS01zv9Xi10.

The LimFlow PROMISE I Study included subjects with no option for further surgical or endovascular revascularization, making them one of the most complex grou...

12/21/2021

Steven K*m, MD, a vascular surgeon in the Department of Surgery at Changi General Hospital (CGH) in Singapore, has the distinction of being the vascular surgeon who performed the first-in-man LimFlow procedure.

For K*m, it was the close collaboration with the company and the relationship with Tim—which allowed the collaborators to share ideas with a quick turnaround—that led to the development of the current LimFlow device—a MedTech innovation that revolutionized the percutaneous deep vein arterialization procedure.

“With the people of this company, together with a bit of luck and the grace of our patients, we were able to find a solution and end up where we are right now,” said K*m.

Learn more about LimFlow SA’s growth from incubator idea to leading MedTech innovator here: https://youtu.be/V5eBNwMznNQ.

Steven K*m, MD, a vascular surgeon in the Department of Surgery at Changi General Hospital in Singapore, has the distinction of being the vascular surgeon wh...

12/17/2021

When Dan Rose took up his role as LimFlow SA CEO, he admits he had less knowledge than he should have. Throughout his time with the company, though, he’s met numerous people who spoke of relatives affected by peripheral artery disease (PAD), chronic limb-threatening ischemia (CLTI), and major amputation.

But nobody, he said, wants to talk about it. And compared with CLTI, other so-called marquee disease states—like diabetes—simply get more attention.

“Why there has been no recognition for this disease is a mystery,” said Mary Yost, MBA, President of the Sage Group LLC. “I’ve been doing this for 20 years, and it’s like CLTI is this orphan disease that nobody’s ever heard of.”
The lack of awareness has been deadly, with PAD- and CLTI-associated mortality higher than that of even COVID-19. And like any epidemic or pandemic, there are very real socioeconomic, racial, and sex-based disparities.

“There’s not been a PAD or CLTI champion,” said Yost. With a celebrity face bringing awareness to the disease—someone with a reach like Oprah, for example—the public might one day be aware of PAD, CLTI, and their terrible impact on both life and limb.

Watch the rest of the interview with Dan Rose and Mary Yost here: https://youtu.be/-vud8aVrYVk

When Dan Rose took up his role as LimFlow CEO, he admits he had less knowledge than he should have. Throughout his time with the company, though, he’s met nu...

12/14/2021

“Dan Clair is one of the most respected vascular surgeons in America,” explained Dan Rose, CEO at LimFlow, in an interview with Joe Mullings, Chairman of the Board of TMG360 Media. “We wanted to work with those folks that weren’t going to be the people who jump on every new technology to come through but were going to be the ones who could really help us understand the technology and, ultimately, be advocates for the technology.”

While venous arterialization has been around as a concept for the last 120 years, LimFlow is the first to introduce venous arterialization through a percutaneous approach. This may be a significant breakthrough as these patients may not have enough blood flow to heal incisions and large operations.

Many of these patients have heart disease, lung disease, diabetes, and obesity, which makes it more difficult to perform open surgical procedures. Doing so percutaneously can reduce the overall morbidity, according to Dan Clair, MD Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center.

Watch the full interview with Dr. Clair, Dan Rose, and Mullings here https://youtu.be/PuAHiUyGsJU.

“Dan Clair is one of the most respected vascular surgeons in America,” explained Dan Rose, CEO at LimFlow, in an interview with Joe Mullings, Chairman of the...

12/07/2021

Roberto Ferraresi, MD, an interventional cardiologist at the Clinica SAN CARLO, Paderno Dugnano in Milan, Italy, has been involved with LimFlow since the company first connected with the clinical community many years ago. Since then, he’s experienced the full force of the network surrounding LimFlow SA, from industry to physicians to patients and beyond.

“We think we’re alone, facing the problem with our patients on the frontline,” he said. “But this isn’t true; we’re not alone.”

As LimFlow flipped the script on saving what’s seen as unsavable, the community of supporters has grown and today includes stakeholders at all levels. It’s a network, said Dr. Ferraresi, in which everybody takes part.

“This changed completely my way of thinking about my work,” he said.

Hear more of what Dr. Ferraresi had to say about the LimFlow community in the full clip: https://youtu.be/YdSa9HqH7qY.

Roberto Ferraresi, MD, an interventional cardiologist at the Clinica San Carlo, Paderno Dugnano in Milan, Italy, has been involved with LimFlow since the com...

12/02/2021

“Venous arterialization is a mechanism allowing us to deliver oxygenated blood flow to the feet through the venous system. Normally, when we do revascularization, what we’re trying to do is to restore blood flow through the arteries, but these patients have no arteries in their feet to deliver oxygen to the capillaries,” explained Daniel Clair, MD, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center in an interview with LimFlow SA CEO Dan Rose.

“What we’re doing in this situation is using the veins, which normally carry blood flow from the foot up to the heart, using those veins to carry blood flow into the foot.”

In the interview, Dr. Clair further explained how he was especially interested in LimFlow’s procedure as a solution because these patients have no other medical options left to save their limbs, and their risk of amputation is extremely high.

Patients in the PROMISE I study were adjudicated by an independent group of vascular surgeons to have no option for further surgical or endovascular intervention and were at risk of lower limb amputation prior to the deep vein arterialization procedure.

Watch the full clip with Dr. Clair, Dan Rose, and Joe Mullings, Chairman of the Board of TMG360 Media, here https://youtu.be/5E5D_onq-ws.

“Venous arterialization is a mechanism allowing us to deliver oxygenated blood flow to the feet through the venous system. Normally, when we do revasculariza...