October 21, 2019
FDA Clears Sky Medical Technology's Geko Calf-Stimulation Device for VTE Prevention
October 22, 2019—Sky Medical Technology Ltd, a United Kingdom–based medical devices company, announced FDA 510(k) clearance for its Geko device for stimulation of the calf muscles to prevent venous thrombosis in nonsurgical patients at risk for venous thromboembolism (VTE). The Geko device was previously cleared for immediate postsurgical stimulation of calf muscles to prevent VTE, increasing blood circulation and edema reduction.
According to the company, the Geko is a noninvasive, easy-to-use, battery-powered, wearable therapy. The daily disposable device is the size of a wristwatch and worn at the knee. It gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf. The Geko device operates without external pressure to the leg and allows complete mobility.
A study of the Geko device to prevent VTE in acute stroke patients was led by Indira Natarajan, MD, consultant stroke physician and Clinical Director for Neurosciences, and Professor Christine Roffe, MD, at the NHS Royal Stoke University Hospital in Stoke-on-Trent, the United Kingdom.
The study reported 0% VTE and good patient tolerance in patients wearing the Geko device alone, compared with VTE in patients prescribed sequential compression devices (SCDs) at 2.4% or pharmacologic prophylaxis at 0.8%. Additionally, the investigators determined that 30% of patients are contraindicated or became intolerant to SCDs (ie, discomfort or dislike of SCDs). It is to this unmet-need cohort that the Geko device was fitted, reporting a zero VTE incidence and good patient tolerance, noted Sky Medical Technology.
In the company’s announcement, Dr. Natarajan commented, “The real-world data have 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. The Geko device is now in routine use at the Royal Stoke and has marked significant change to our practice.”
Fred Rincon, MD, who is Professor of Neurology and Neurological Surgery at the Thomas Jefferson University in Philadelphia, Pennsylvania, added, “The Geko device represents an exciting new treatment option for clinicians to manage stroke patients at risk for developing a deep vein thrombosis when clinicians are concerned about bleeding in the early management of the patient.”