Sky Medical Technology said yesterday that it received FDA 510(k) clearance for its Geko electrostimulation device for preventing venous thrombosis.
The Daresbury, England-based company’s Geko device is designed to stimulate the calf muscles to increase blood flow in the deep veins of the calf, preventing venous thrombosis in non-surgical patients at risk for venous thromboembolism. The non-invasive, battery-powered wearable device is designed to operate without external pressure to the leg and allow complete mobility.
The company cited a study, led by NHS Royal Stoke University Hospital clinical director for neurosciences Dr. Indira Natarajan, which used the Geko device to prevent VTE in acute stroke patients. The results showed 0% VTEs in patients wearing the Geko device alone, along with good patient tolerance.
The study compared that to the use of sequential compression devices (SCDs) or pharmacological prophylaxis and fond that 30% of patients are contraindicated or became intolerant to SCDs.
Sky Medical said it has already established FDA 510(k) clearance for immediate post-surgical stimulation of calves to prevent VTE, but the Geko device is the first muscle pump activator of its kind to win clearance for VTE prevention across all patients.
“The data has shown a need to use the Geko device when other VTE prophylaxis strategies are contraindicated or impractical and provides an option where previously patients would have had no other intervention available to them,” Natarajan said in prepared remarks. “The Geko device is now in routine use at the Royal Stoke and has marked significant change to our practice.”
“This latest 510(k) builds on our previous FDA indications to address life threatening blood clots and complications related to swelling after orthopaedic surgery, conditions experienced by more than 1 million US patients with unmet need every year,” added Sky Medical CEO Bernard Ross. “We are excited to extend our access into the US market. Our muscle pump activation technology, OnPulse, embedded in the Geko device, completely redefines the way vascular related conditions are treated. Through our innovative mechanism of neuromuscular electrostimulation, we are the first clinically proven muscle activation technology to prevent and treat a wide range of acute and chronic circulatory conditions both here in the US and internationally. New care pathways are in development in neurology, orthopaedics, renal, and peripheral vascular disease and we plan to submit further FDA applications to expand our claims.”