By Chris Wack
Hancock Jaffe Laboratories Inc. said the U.S. Food and Drug Administration has granted breakthrough device designation status to VenoValve, its lead product, which is 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 medical device company said VenoValve is a potential treatment for chronic venous insufficiency, which occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction and creating increased pressure inside of the veins of the leg.
The primary endpoint for the new U.S. trial will be the occurrence of material adverse effects in less than 10% of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30% at six months following VenoValve surgery.
Hancock Jaffe shares were up 37% to $9 in premarket trading.
Write to Chris Wack at firstname.lastname@example.org
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