CorVascular’s VasoGuard® Earns FDA 510(k) Clearance
29 Julio 2024 - 6:00AM
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 CorVascularCorVascular 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.Follow CorVascular on X, Facebook, LinkedIn, and all other
platforms.For more information visit: www.CorVascular.com
Spencer Lien
763-333-1540x511