FDA APPROVES CARDIACASSIST'S TANDEMHEART ESCORT CONTROLLER

CardiacAssist has received FDA 510(k) market approval for its new TandemHeart Escort Controller, the firm said Oct. 2.

The device is one of three primary components that make up the TandemHeart PTVA (percutaneous transseptal ventricular assist) System, the firm said.

The TandemHeart system provides circulatory support through a cardiac catheterization procedure in as little as 30 minutes, the firm said. The new Escort controller weighs only 21 pounds, replacing the original 93-pound TandemHeart controller, and can be mounted at bedside or on an IV pole or tabletop, the firm added.

CardiacAssist collaborated on the project with Minnetronix, a contract design and manufacturing company.