Poised to be one of the latest generation ventricular assist devices (VADs) to win FDA approval is the HeartMate II from Thoratec (Pleasanton, California).

The company featured the device during the Scientific Sessions of the Heart Failure Society of America (St. Paul, Minnesota) by making available at its exhibit area two real-life case studies: two people implanted with the device.

One was a 66-year-old, accompanied by his wife, and another a man in his late 30s, taking turns in two-hour segments to talk to exhibit attendees, explaining their experience with the device and testifying to their improved health.

The 66-year-old said he had been unable to walk across the room because of heart failure but was now experiencing renewed energy, as clearly demonstrated by his participation at the exhibit, morning and afternoon. Even more significantly, shortly before being implanted with the Heartmate II, he had undergone brain surgery and then a hip replacement.

The second of these human case studies was an elementary school physical education teacher who said he has been able to return to that work and was now participating in many of the activities with his students.

The FDA's circulatory systems panel is scheduled to review the premarket application for the Heart II next month. With a positive recommendation, the Heartmate II has been projected as potentially reaching the market in 1Q08.

— DON LONG