FDA gives unconditional IDE approval to Berlin Heart’s EXCOR
The U.S Food and Drug Administration (FDA) has given an unconditional Investigational Device Exemption to Berlin Heart Inc.’s EXCOR(R) Pediatric ventricular assist device (VAD).The device is a cardiac support system that is useful for pediatric patients who are critically ill and have been suffering from a severe heart failure. The system is a great support for patients waiting for a heart donor for transplantation.
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- CE Mark approval for Cook Medical’s microcatheter
