LimFlow said today it won CE Mark approval in the European Union for its percutaneous LimFlow system designed for venous arterialization of the lower limbs for peripheral artery disease patients.
The company said the device is designed to promote chronic wound healing and avoid major amputation using proprietary ultrasound guided catheters and nitinol stents to bypass diseased arteries and divert blood flow into the tibial vein.
“Utilizing the existing alternative pathway of the venous vasculature, the LimFlow System is designed to reestablish perfusion for patients that have chronic, non-healing wounds and are in imminent danger of losing a limb. We can now provide an option for patients that have none today. In early clinical cases, we have seen patients with extensive and severe foot wounds, including gangrene, fully heal following treatment with the LimFlow therapy, becoming mobile and active again,” CEO Dan Rose said in prepared remarks.
The approval was supported by a CE Mark clinical study of the device, with initial clinical results presented this year and publication “expected soon.”
“Due to the ongoing epidemic of diabetes and cardiovascular disease, every year more and more patients are presenting with end-stage CLI, and the tools we have to treat them are limited. The LimFlow System is a new and critically important option for patients who suffer substantially from their ischemic foot. This therapy will create a strong foundation for us as vascular specialists, working with a wound care team, to provide new hope for them,” Dr. Steven Kum of Singapore’s Changi Hospital said in a press release.
Prior to his time with Direct Flow, Rose worked as VP of commercial operations for Sequana Medical AG, developer of implantable pump systems.