FDA clears muscle stimulator for increasing blood flow in the lower legs

FDA clears muscle stimulator for increasing blood flow in the lower legs

The FDA greenlighted a wearable electrical muscle stimulator to help stave off some of the symptoms of chronically blocked vessels such as varicose veins and blood pooling in the legs.

The geko device, about the size of a wristwatch, from the U.K.-based Sky Medical aims to increase circulation by stimulating a central nerve located at the top of the shin and boosting blood flow through the veins and arteries of the lower limbs.

The disposable hardware, worn around the bottom of the knee, sends pumping signals to muscles in the calf and foot that help to increase blood flow in the deeper veins of the calf without applying any external pressure and allowing the leg to have complete mobility.

The 510(k) clearance will enable the company to begin a controlled market release of the geko for first-line treatment of venous insufficiency and ischemia, Sky founder and CEO Bernard Ross said in a statement.

The company also plans to submit additional 510(k) applications to the FDA to expand its claims related to blood flow and venous insufficiency.

The latest U.S. regulatory green light adds to the company’s portfolio for reducing fluid-based swelling in the feet and ankles as well as for the stimulation of the calf muscles to prevent blood clots in the veins of patients including those undergoing surgery.

Sky estimates that about 150,000 people are diagnosed with chronic venous insufficiency annually, with incompetent blood valves in the veins causing most cases, and that if the condition is left untreated it can lead to leg ulcers and other complications.

This month has seen two major medtechs opt into the chronic venous insufficiency market with new acquisitions.

BD picked up Venclose for its vein therapy portfolio for an undisclosed sum, adding a radiofrequency ablation catheter that shrinks and closes off compromised veins, allowing the blood to naturally reroute itself through healthier vessels nearby. BD and Venclose estimate chronic venous insufficiency affects up to 40% of women and 17% of men in the U.S.

Meanwhile, Philips moved to buy Vesper Medical, also for an undisclosed amount. Vesper’s Duo stent system will be used alongside Philips’ interventional imaging hardware and intravascular ultrasound catheters.

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