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Sky Medical Technology Nabs FDA Clearance for VTE Device

The Daresbury, England-based company’s geko works by gently stimulating the common peroneal nerve and activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf.

Sky Medical Technology Ltd. won FDA clearance for a device that stimulates calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism.

The Daresbury, England-based company said the geko device is the first muscle pump activator of its kind to be cleared by FDA for VTE prevention across all patients.

Sky Medical Technology’s geko is a non-invasive battery-powered, wearable therapy device that is about the size of wristwatch. The technology is worn at the knee. Geko works by gently stimulating the common peroneal nerve, activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf.

A study of the geko device to prevent VTE in acute stroke patients reported 0% VTEs in patients wearing geko device alone, compared to VTEs in the various control groups prescribed sequential compression devices at 2.4% or pharmacological prophylaxis at 1.1%. The investigators, led by Dr. Indira Natarajan, consultant stroke physician and clinical director for neurosciences at the NHS Royal Stoke University Hospital, also determined that 30% of patients are contraindicated or became intolerant to SCDs (discomfort or dislike to SCDs). It is to this unmet need cohort that the geko device was fitted, reporting a zero VTE incidence and good patient tolerance. The data has driven rapid adoption across multiple NHS trusts and international markets, as well as the expanded FDA clearance.

Commenting on FDA’s clearance, Sky CEO Bernard Ross said, "This latest 510(k) builds on our previous FDA indications to address life-threatening blood clots and complications related to swelling after orthopedic surgery, conditions experienced by more than one million US patients with unmet need every year. 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, orthopedics, renal, and peripheral vascular disease and we plan to submit further FDA applications to expand our claims."

 

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