CorVascular’s VasoGuard® Earns FDA 510(k) Clearance

Comprehensive suite of peripheral vascular testing devices set to enter US market

/EIN News/ -- MINNEAPOLIS, July 29, 2024 (GLOBE NEWSWIRE) -- CorVascular, a leading producer of peripheral arterial disease (PAD) / peripheral vascular disease (PVD) testing devices, today announced the U.S. Food and Drug Administration (FDA) has cleared its VasoGuard V-Series as Class II medical devices. The clearance allows CorVascular to immediately begin marketing and selling the devices to clinics, hospitals, and teaching institutions across the country, expanding access to diagnostic testing for a disease medical experts say is causing an amputation epidemic in the US.

According to the American Heart Association, PAD / PVD is present in over 12 million Americans and 200 million individuals worldwide. In these patients, limb symptoms may reduce quality of life, and the devastating outcome of limb amputation results in social and economic burdens for both patient and family. Early identification allows for timely initiation of guideline-directed medical therapy for secondary prevention of cardiovascular disease, cerebrovascular disease, and limb events.

“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,” said Spencer Lien, Founder and Managing Director at CorVascular. “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.”

The newly cleared VasoGuard suite includes five devices each with unique combination of sensors and capabilities, including up to three continuous wave Doppler probes with full color spectrum, up to five wearable photoplethysmography (PPG) sensors, and up to 10 pulse volume recording (PVR) channels.

The VasoGuard V-Series signifies a significant step forward for physiologic testing in international standards compliance. Unlike older legacy systems, VasoGuard achieved FDA clearance after having completed rigorous certification testing on the entire system, including electrical safety IEC 60601-1, electromagnetic disturbances IEC 60601-1-2, wireless immunity, cybersecurity, and all other standards required by FDA. These certifications included the device, touchscreen computer, mobile cart, and all accessories approved as a system; paving the way for fast acceptance with confidence by medical directors, hospital biomed, and IT decision-makers.

CorVascular is now accepting orders for its V2, V4, V6, V8, and V10 VasoGuard systems. Existing customers have the option to trade-up. Contact CorVascular for more information or to arrange a demonstration.

About CorVascular
CorVascular develops, manufactures, and markets innovative vascular testing technologies and is committed to its core strength in delivering accurate and reliable solutions to healthcare providers. Proudly headquartered and producing its products in the USA in the great state of Minnesota, CorVascular is privately held, eco-conscious, and an equal opportunity employer.
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For more information visit: www.CorVascular.com

Spencer Lien
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