HJLI > IRVINE, CA / ACCESSWIRE / August 3, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) ("Hancock Jaffe" or the "Company"), a developer of medical devices that restore cardiac and vascular health, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the VenoValve®, the Company's lead product, which is currently set to begin its U.S. pivotal trial. The FDA's Breakthrough Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.
The VenoValve is a potential treatment for a condition called Chronic Venous Insufficiency (CVI), a disease that afflicts approximately 2.4 million people in the U.S. CVI occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and creating increased pressure inside of the veins of the leg (venous hypertension). CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping, and walking extremely difficult for patients. There are currently no effective treatments for deep venous CVI.
"We are very pleased to have the opportunity to work with the FDA on an expedited basis as we try to bring relief to the millions of patients who suffer from deep venous CVI and who currently have no effective treatment options," said Hancock Jaffe CEO Robert Berman. "The VenoValve significantly improved the lives of the patients in our first-in-human study, and we hope to replicate that success in our SAVVE U.S. clinical trial."
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