FDA clears medical device company’s full line of vascular testing systems
CorVascular, a Minnesota-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) clearance for its VasoGuard V-Series portfolio of devices designed to test patients for signs of peripheral artery disease (PAD) and/or peripheral vascular disease (PVD).
The newly cleared devices include the V2, V4, V6, V8 and V10 VasoGuard systems, which are built to help identify signs of PAD and/or PVD in patients when it is still early enough to avoid limb amputation. Each offering includes up to three continuous wave Doppler probes with full color spectrum, up to five wearable photoplethysmography sensors and up to 10 pulse volume recording channels. The devices come with a touchscreen computer, mobile cart and various accessories.
“FDA 510(k) clearance of the VasoGuard V-Series is a significant achievement for our entire team who has been working diligently on this milestone for several years,” Spencer Lien, founder and managing director at CorVascular, said in a statement. “The VasoGuard V-Series is the first full suite of devices designed for primary care, specialists, all the way up to and including the vascular testing labs in major health institutions and academic centers of excellence. It has been over a decade since anything new has come to this market and the VasoGuard is a perfect fit; the right line at the right time.”
CorVascular is already accepting orders for all five devices.
PAD linked to rising amputation rates
PAD, PVD and critical limb ischemia (CLI) are all associated with a staggering number of limb amputations. In fact, it is believed that as many 400 CLI-related amputations are performed each day in the United States.
U.S. healthcare providers are doing more and more to try and address the country’s ongoing problem. Interventional cardiologist Foluso Fakorede, MD, for instance, opened a practice in Cleveland, Mississippi, specifically to try and improve PAD and CLI outcomes.
In Oklahoma, meanwhile, vascular surgeon Jim Melton, DO, launched a mobile cardiology clinic program to bring better care to patients in the most remote parts of the state.
The Society for Cardiovascular Angiography and Interventions (SCAI) is focused on this issue as well, launching the Get a Pulse on PAD campaign.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.