A Medical Device Daily

Thoratec (Pleasanton, California) has had its share of lows in terms of news in recent months. While still riding high on earlier reports of a significant revenue increase in March, the company, which makes products to support the failing heart, must contend with the FDA delaying its Heartmate II (HMII) device and several device recalls.

Thoratec reported that the real driver of its performance, the Heartmate II, a ventricular assist device, has been pushed back due to FDA concerns regarding the data interpretation of the devices trial. The device’s approval timeline is now scheduled for 1Q08, up from an expected approval in 3Q07. The company’s strong performance during 1Q07, which included an 18% increase in revenues was said to bode well for the HMII, once it launched (Medical Device Daily, May 7, 2007).

On top of that delay Thoratec is still contending with the fallout from recalls on 378 TLC-II portable VAD Drivers manufactured or serviced since September, 2005; and 2,484 paracorporeal ventricular assist devices (PVAD) manufactured and distributed prior to October 2006.

The TLC-II recall, which was initiated in early June, relates to increased reports of premature motor failure, possibly resulting in the loss of VAD support for a patient’s circulatory system. The PVAD recall initiated on April 9 relates to improper assembly during surgical implantation which has resulted in three deaths since 1996.

The PVAD’s manufactured prior to October 2006 included black collets and collet nuts used to secure the cannula to the pump that have been involved in several reports of incorrect assembly with the inflow cannulae during surgical implantation, which has in three cases resulted in severe bleeding and death. The affected PVADs were distributed directly to 149 hospitals throughout the U.S. and other countries. Thoratec notified its customers of the recall by letter on April 9 and is arranging for the application of conspicuous warning labels to all recalled products remaining in hospital inventory. As of July 13, the company’s records indicated that the application of warning labels to affected PVADs is 92% complete.

The recalls are unlikely to affect sales of either devices the company said. The TLC-II recall could result in slightly higher service costs with shorter service intervals. Still the company is touting that this will be “immaterial” to its bottom-line.