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.

The FDA has approved Life Recovery Systems’ Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks. The patients enrolled in the study will be given hypothermia along with Life Recovery Systems ThermoSuit(R) non-invasive cooling system. The patients will undergo cooling in the emergency room within one hour of their arrival and the door-to-balloon time will not extend beyond 90 minutes.