Mountain View, CA (October 15, 2018) – Radial Medical announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its first-generation compression therapy device, Cirvo.
Pneumatic devices are used in hospitals to provide intermittent compression therapy to prevent deep vein thrombosis after surgery. It is recommended by xx that compression therapy continue for xx days post-surgery. However, because pneumatic devices are impractical outside a hospital setting, most patients do not continue compression therapy after they are discharged from the hospital within a day or two of surgery.
Cirvo was developed to bring compression therapy into the home, particularly for hip and knee replacement patients. “The number of joint replacements is predicted to triple in coming years as aging baby-boomers seek to continue stressful physical activity as they age,” says Eric Johnson, CEO and Co-Founder of Radial Medical. The Cirvo device is a battery-powered digital therapeutic that patients can operate through a smartphone app or a simple on/off switch.
The Cirvo delivers an adjustable level of compression ranging from 35 to 60 mmHg. The fastest cycle time of less than one second is capable of offering best-in-class compression in a truly portable device. The smartphone app can track and monitor both the dose of compression and patient compliance and alert either a clinician or care-giver if the patient is not using the compression as instructed.
There is currently no private payer reimbursement for DVT prophylaxis in patients contraindicated for anticoagulants. However, Johnson believes in a value-based payment model, the Cirvo will become cost effective for hospital systems because of the potential of reducing readmissions.
The company is also investigating the potential of its device as a treatment for restless leg syndrome. Currently there are few treatments for these patients aside from medications including opioids. An hour a day of compression therapy has been shown to be effective at treating RLS symptoms, and the company is initiating a clinical trial in early 2019 to determine efficacy.
Radial Medical is based in Mountain View, CA at the Fogarty Institute for Innovation. It was founded in 2015 by Johnson and James Wall, MD, a pediatric surgeon at the Stanford School of Medicine.
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