LimFlow said today that it won an investigational device exemption from the FDA for a pivotal trial of its catheter-based intervention for a severe form of peripheral artery disease.
LimFlow’s percutaneous deep vein arterialization device is designed to re-route blood flow from a blocked artery through the venous system to deliver oxygenated blood to the foot and lower leg.
The Paris-based company said the three-year Promise II trial is a prospective, single-arm adaptive statistics study designed to enroll 60 to 120 “no option” patients with chronic limb-threatening ischemia, whose only other treatment option is amputation. Endpoints include amputation-free survival at six months, limb salvage and wound healing, LimFlow said.
“Major amputations have a devastating effect on the lives of patients and their families, and each one is a personal tragedy. Chronic limb-threatening ischemia is a public health crisis and far too many limb amputations are performed in the world today, costing the healthcare system many billions of dollars,” CEO Dan Rose said in prepared remarks. “As part of the FDA breakthrough devices program, LimFlow is excited to commence its U.S. pivotal trial on the heels of the successful experience from the U.S. feasibility study. This is a tremendous milestone that furthers our mission of empowering vascular specialists to offer new hope to their CLTI patients who may be only days away from losing a limb.”
“For these late-stage CLTI patients, success can be defined in two ways: wound healing and amputation-free survival. This exciting new therapy has the potential to restore blood flow to the ischemic foot, which may help patients heal their wounds and keep their feet. I am very encouraged by the early experiences in the U.S., and outcomes from this pivotal trial may offer hope to the many Americans who might otherwise face major amputations,” added principal investigator Dr. Daniel Clair of the University of South Carolina.
Interim data on 10 of 32 patients enrolled in a pilot study, Promise I, showed a 90% rate of survival and freedom from amputation at one year and a 70% rate of complete wound healing. Complete results are slated to be released as a late-breaker at the annual Vascular Interventional Advances conference in Las Vegas in November, LimFlow said.
In April 2018 LimFlow raised about $33.5 million in an oversubscribed Series C round.