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 non-surgical patients at risk for venous thromboembolism (VTE).
This adds to previous 510k clearance geko™ received for immediate post-surgical stimulation of calf muscles to prevent VTE, increasing blood circulation and edema reduction. This is the first bioelectronic muscle pump activator of its kind to be cleared by the FDA for VTE prevention across all patients including non-surgical patients.
VTE is a deadly risk to hospitalized patients, particularly those who are immobile as a result of recovery and fewer than 50% of hospital patients receive appropriate preventive treatment, according to the CDC (Centers for Disease Control). Estimates suggest that 60,000 – 100,000 Americans die each year as a result of the condition, with 10 to 30% of patients dying within one month of diagnosis.
The geko™ device is a non-invasive, easy to use, battery powered, wearable therapy device. The size of a wristwatch and worn at the knee, the daily disposable device 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 reported 0% VTE in patients wearing the geko™ device alone, along with good patient tolerance, compared to VTE in patients prescribed sequential compression devices (SCD) at 2.4% or pharmacological prophylaxis at 0.8%.
The investigators, led by Dr. Indira Natarajan, consultant stroke physician and clinical director for neurosciences and Professor Christine Roffe 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 the study, Dr Natarajan said, “The real-world 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. The geko™ device is now in routine use at the Royal Stoke and has marked significant change to our practice.”
Embracing the innovation, Dr Fred Rincon, Professor of Neurology and Neurological Surgery at the Thomas Jefferson University 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.
Commenting on the FDA 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 orthopaedic surgery, conditions experienced by more than 1 million US patients with unmet need every year. We are excited to extend our access into the US market. Our bioelectronic medicine therapy, 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 bioelectronic compression 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.”
And finally, commenting on what differentiates Sky as an exciting investment opportunity, is Edward Rudd, partner at Juno Capital. “Getting a first product into a hospital takes a lot of time and money. Getting the same product, once in the hospital, to be used on additional patient groups is a lot quicker and costs less. We like to invest in products that have benefits for multiple patient groups for these reasons. We find they provide dramatically enhanced returns when compared to products that provide benefit to a more limited number of patients. The geko™ device is an excellent example.”
- VTE primary prophylaxis space is specifically projected to grow from US$2.4bn in 2015 to U$3.5bn by 2025, at a CAGR of 4.01%., September 19, 2016 – 13:01. Owen – Editor in chief, Venous Times.