This is the first time I've tried to cut and paste -- sorry if it doesn't come out properly. I think the following is the article that the thread's been discussing.
Lorraine McConaghy
Wednesday September 17 1:47 PM EDT
Medtronic says halts Gem DR ICD implants
CHICAGO, Sept 17 (Reuter) - Medtronic Inc said Wednesday it halted implants of its Gem DR implantable cardioverter defibrillator, or ICD, after a problem was detected in one of the advanced heartbeat-regulating medical devices.
``We hope to resume implants in mid-November,'' said Dick Reid, spokesman for the Minneapolis-based medical devices maker.
The company said implants were ordered halted on August 29. ``We have now identified the problem and are implementing the fix,'' Reid said.
A component problem was discovered in one device that was associated with the charging circuit, he said.
``Even though we have had no performance problems with any of the devices that had been implanted ... we suspended and have done no more implants,'' he said.
The device -- a small electronic unit implanted in the chest and wired to the heart to keep it from beating too fast or irregularly -- is not sold in the United States. Medtronic is awaiting FDA approval to begin U.S. clinical trials with the Gem DR, the latest in a line of successful ICDs made and marketed over the years by Medtronic.
All of the unspecified small number of Gem DR implants done to date have been in Europe, where the device is in clinical evaluation. ``It hasn't been released commercially anywhere,'' Reid said.
Industry analysts had expected U.S. commercial release of the device in early to mid-1998.
``If we don't implant until mid-November, there conceivably could be some delay. But we hope to get it back on schedule rather quickly,'' Reid said.
The Gem DR is targetted to compete with a similar, commercially available device made by Guidant Corp (GDT) in the rapidly growing market for dual-chamber ICDs, which can treat both the upper and lower portions of the heart.
Reid said there were no patient injuries associated with the Gem DR implant halt. |
