CorVascular announced today that the FDA granted clearance for its VasoGuard V-Series portfolio of devices.
Minneapolis-based CorVascular plans to immediately begin marketing and selling the devices across the country. The newly cleared suite includes five devices, each with a unique combination of sensors and capabilities for physiologic testing. It features a device, touchscreen computer, mobile cart and a number of accessories approved as a system.
CorVascular developed the devices to test for peripheral arterial disease (PAD) and/or peripheral vascular disease (PVD). They could provide early identification to initiate guideline-directed medical therapy, potentially preventing cardiovascular disease, cerebrovascular disease and limb events such as amputation.
VasoGuard includes up to three continuous-wave Doppler probes with a full-color spectrum and up to five wearable photoplethysmography (PPG) sensors. CorVascular also designed the suite to offer up to 10 pulse volume recording (PVR) channels. The company developed the suite for primary care, specialists and vascular testing labs across health institutions and academic centers.
“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. “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.”
