French medical device company LimFlow has received the US Food and Drug Administration (FDA) approval for its LimFlow System for Transcatheter Arterialisation of Deep Veins (TADV).

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

It is designed to restore blood flow in deep veins for no-option CLTI patients, saving their legs from major amputation, and associated complications, mortality and decline in quality of life.

LimFlow System is the first and only FDA-approved device for TADV and provides no-option CLTI patients with access to a minimally invasive treatment, said the medical device maker.

PROMISE 2/3 study co-principal investigator Daniel Clair said: “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.

“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.”

The US FDA approval was based on recently published positive data from the PROMISE 2 clinical trial, and from positive clinical results in previous clinical trials.

In the PROMISE 2 trial, LimFlow treatment enabled 76% of no-option CLTI patients to keep their leg and experience progressive wound healing and significant pain relief.

The LimFlow System has been granted the CE mark and is currently available in Europe.

LimFlow CEO Dan Rose said: “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.

“We thank the FDA for their collaborative review process and we look forward to introducing and expanding the use of the LimFlow System in the US.”

LimFlow is a medical device company, engaged in developing minimally invasive technology for the treatment of CLTI, a severe form of peripheral artery disease (PAD).

In April last year, LimFlow secured $40m in funding from existing investors, new investors Longitude Capital, and Soleus Capital Management along with an undisclosed investor.

The medical device company used the proceeds to support a clinical programme for its novel system to treat CLTI, a severe form of peripheral artery disease (PAD).