Medtronic backs heart-lead report that irks St Jude

CHICAGO | Mon Apr 9, 2012 7:56pm EDT

CHICAGO (Reuters) – Medtronic Inc said on Monday it agreed with research findings that favored the medical device maker’s Sprint Quattro heart defibrillator lead over a rival product by St Jude Medical Inc.

St Jude on Friday urged medical journal HeartRhythm to retract an article on the research written by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation.

Hauser had analyzed data on lead failures and death rates for St Jude’s Riata and Riata ST defibrillator leads – which were discontinued in December 2010 because of insulation problems – and Medtronic’s Quattro leads.

He concluded that St Jude’s leads, which are insulated wires that connect an implanted defibrillator to the heart, were prone to failures that led to deaths. Fewer deaths were linked to the Medtronic lead, he said, based on data from the U.S. Food and Drug Administration’s MAUDE database.

St Jude said Hauser’s analysis undercounted reports of deaths involving Medtronic’s Quattro leads.

Medtronic, however, said it reviewed the data on Quattro, following criteria outlined in Hauser’s article.

“The conclusions we have reached about Sprint Quattro are consistent with what Dr. Hauser found, and we confirm his results related to Sprint Quattro,” Medtronic said in a statement emailed to Reuters.

Hauser said the St Jude lead failures appeared to be caused by insulation defects that resulted in short-circuiting between high-voltage components.

St Jude, in a press release Friday, said its own analysis of the FDA database could not reproduce the numbers reported in the HeartRhythm article. The company also criticized the use of the database to evaluate rates of adverse events and to compare devices.

A spokeswoman for the Heart Rhythm Society, publisher of the HeartRhythm journal, could not be reached for comment on St Jude’s request for a retraction.

St Jude informed doctors last November that the leads have a higher rate of insulation failures than initially reported. The company advised against removing or replacing the leads.

The company said it had reports that two patients had died and one had suffered a serious injury during procedures to remove the leads.

FDA subsequently classified St Jude’s advisory as a recall.

Last week, St Jude halted sales of two more brands of lead wires used in its cardiac resynchronization therapy devices due to worn insulation. Those products, the QuickSite and QuickFlex leads, connect to the heart a device that uses a specialized pacemaker to re-coordinate the action of the right and left ventricles in patients with congestive heart failure.

On the New York Stock Exchange, St Jude fell $2.06, or 5.03 percent, to close at $38.91, and Medtronic ended down 45 cents, or 1.18 percent, at $37.75.

(Reporting By Susan Kelly; Editing by Richard Chang)


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