Physicians from the Minneapolis Heart Institute Foundation and the Mayo Clinic will huddle with electro-physiologists in the Twin Cities Jan. 20 to discuss strategies for dealing with the recall of the Riata defibrillator leads made by St. Jude Medical Inc. (NYSE:STJ).
The FDA slapped the St. Paul, Minn.-based cardiology device maker with a Class 1 recall for the Riata leads in December, after the company said they failed more frequently than previously reported.
Two patients died and another suffered a serious injury when surgeons attempted to extract the leads, according to St. Jude. Another patient died and a 5th was seriously injured, both with compromised Riata leads, but the "externalized conductors" were not found to be responsible, the company said in December. Class I status is the federal watchdog agency’s most serious category, reserved for products with a potential risk of serious injury or death. "Externalized conductors" refers to lead wires poking through their insulation, potentially delivering unwanted shocks to patients. St. Jude said the leads were more prone to "insulation abrasion" than it had reported in the past.
In Minneapolis next week, cardiovascular leaders will meet in order to " to develop a consensus regarding the management of patients who have these leads," according to a prepared release.
Approximately 80,000 patients have been implanted with Riata or Riata ST ICD leads in the U.S., according to the group, which is led by Dr. Robert Hauser, a senior cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and Dr. David Hayes, professor of medicine at Mayo Clinic in Rochester, Minn. Both Hauser and Hayes are past presidents of the Heart Rhythm Society.
The meeting will be held Jan. 20, 2012, from 8 a.m. to 4:30 p.m.