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.
-
Thoratec HeartMate II gets FDA nod
HeartWare files for destination therapy IDE
Sunshine Heart C-Pulse implantable heart assist device passes 5-year durability testing
Zoll Medical receives the FDA approval for new LifeVest model
Life Recovery Systems gets FDA nod for ThermoSuit study
