LimFlow SA

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

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 - Dan Clair, MD of Vanderbilt University Medical Center The LimFlow PROMISE I Study included subjects with no option for further surgical or endovascular revascularization, making them one of the most complex grou...

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.

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