Novel System Snags FDA Approval for Severe Peripheral Arterial Disease

The FDA approved the LimFlow system designed to stave off amputation for people with chronic limb-threatening ischemia (CLTI) and no treatment alternatives, device maker LimFlow SA announced Tuesday.

This puts the first device for transcatheter arterialization of the deep veins, also known as percutaneous deep vein arterialization, on the market for CLTI patients deemed not suitable for other endovascular or surgical revascularization options who are at risk of major amputation.

LimFlow was approved under the FDA's 510(k) pathway based on the PROMISE II study that showed the LimFlow procedure was safe and led to limb salvage and wound healing. With the operation successful in all but one of 105 trial participants, the device was associated with a 66.1% rate of amputation-free survival at 6 months. An estimated 76% of patients avoided above-ankle amputation.

In PROMISE II, the subgroup of people with dialysis had worse outcomes, however: they had a 36.8% amputation-free survival rate at 6 months and 36.2% died.

"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," study investigator Daniel Clair, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, said in the company's press release.

"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," Clair added.

The LimFlow is a minimally invasive device that restores perfusion to the ischemic foot using ultrasound-guided catheters and covered nitinol stents. The system works by turning a vein into an artery that can send oxygenated blood to ischemic tissues.

This strategy bypasses a limitation of conventional revascularization for critical limb ischemia, which is that it requires a landing point -- an unobstructed vessel in the lower leg or foot -- that may be unavailable in people with distal arterial disease.

CLTI is the most severe form of peripheral arterial disease (PAD) often accompanying diabetes, coronary artery disease, obesity, or high blood pressure. PAD is caused by atherosclerosis and becomes more prevalent with older age.

Comment