UK-based medical devices company, Sky Medical Technology Ltd, has received U.S. Food and Drug Administration (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).
This is reportedly the first muscle pump activator of its kind to be cleared by the FDA for VTE prevention across all patients including nonsurgical patients.
The wearable, non-invasive geko device is the size of a wristwatch and worn at the knee, and is designed to gently stimulate the peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf. It operates without external pressure to the leg and allows complete mobility, according to a media release from Firstkind Ltd.
A study of the geko device to prevent VTE in acute stroke patients reported 0% VTEs in patients wearing the 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.
“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 says. “The geko device is now in routine use at the Royal Stoke and has marked significant change to our practice.”
“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,” notes Dr Fred Rincon, Professor of Neurology and Neurological Surgery at the Thomas Jefferson University, in the release.
“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,” Sky CEO Bernard Ross comments.
“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.”
[Source(s): Firstkind Ltd, PR Newswire]