Sky Medical Technology Ltd. has cinched FDA clearance for a third indication for its geko device, a noninvasive, battery-powered wearable technology designed to increase blood flow in the deep veins of the lower legs. The Daresbury, U.K.-based company already had the agency's blessing for geko's use immediately after surgery to stimulate the calf muscles to prevent venous thromboembolism (VTE) and preoperative reduction of edema. Now the FDA has granted geko 510(k) clearance for stimulation of calf muscles to curb venous thrombosis in nonsurgical patients at risk of VTE.
According to the company, the geko is the first muscle pump activator of its kind to be cleared by the FDA to prevent VTE in all at-risk patients, including nonsurgical patients. "Now that we have this latest clearance, we will formally launch the geko device for VTE prevention across all at-risk patient groups and in particular acute stroke," Bernard Ross, Sky Medical's CEO, told BioWorld MedTech. "We are also submitting a 510(k) for blood flow with regard to wounds."
VTE is the third leading vascular diagnosis in the U.S. after heart attack and stroke, affecting anywhere from 300,000 to 600,000 Americans each year. Immobilized patients are at high risk for VTE, which is a blood clot that starts in a vein, yet less than half of hospitalized patients who need such preventive treatment receive it, according to the Centers for Disease Control and Prevention. The CDC estimates that the condition kills as many as 100,000 people each year, 10%-30% of them within a month of diagnosis.
The FDA based its decision on a study comparing the geko with sequential compression devices (SCDs) and pharmacological prophylaxis in preventing VTEs in acute stroke patients. The results showed no VTEs in patients wearing geko vs. 2.4% in controls who were prescribed SCDs and 1.1% with preventive medication. Researchers also found that geko filled an unmet need, as 30% of patients were either contraindicated or couldn't tolerate the SCDs. By, contrast, the study team reported good patient tolerance with geko.
"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," said lead investigator Indira Natarajan, clinical director of neurosciences at the NHS Royal Stroke University Hospital in the U.K. "The geko device is now in routine use at the Royal Stroke and has marked significant change in our practice."
About the size of a wristwatch and worn at the knee, the self-adhesive geko is embedded with Sky Medical's Onpulse muscle pump activation technology, which stimulates the peroneal nerve in the calf to boost circulation and reduce the risk of blood clots. The device exerts no external pressure and doesn't restrict mobility. For acute stroke VTE prevention, patients typically wear the device for five to nine days following the stroke. For pre-op patients with edema, a two-day course of therapy has been shown to speed time to surgery, reducing health care costs, Ross said. To heal chronic wounds may require wearing a geko for weeks or even months, which has led to a different version of the device.
In addition to its FDA clearances, the geko is CE marked in Europe for six applications: increase blood circulation; prevent venous thrombosis; prevent and treat edema; treat venous insufficiency and ischemia; and promote wound healing. The device also is recommended by the U.K.'s National Institute for Health and Care Excellence for VTE prevention for all at-risk patients.
The Geko is not the only FDA-cleared stimulator on the market for treatment of VTE, but it is the only one cleared for all patient groups. New York-based Flowaid Medical Technology Corp.'s FA100 sequential continuous contraction device got a green light from the FDA in 2017 for postsurgical stimulation of calf muscles to prevent VTE, but is not authorized for use with nonsurgical patients.
Looking to the future, Sky Medical sees potential uses for the geko in neurology, orthopedics, renal and peripheral vascular disease. But for now, the primary focus is on building brand adoption and awareness in the U.S. "The commercial aim is to develop U.S. reference centres for DVT (stroke) and oedema (ortho) and use them to generate U.S. data, awareness and adoption," Ross said.
To that end, he said that the company is looking for a U.S. distributor to partner on the VTE and edema applications. It has also engaged key opinion leaders in targeted hospitals and surgery centers to help amass U.S. clinical data on geko. "This strategy is coming together and resulting in real-world data generation and RCTs [randomized controlled trials]," Ross said.