St. Jude Medical Inc. (STJ) said it is seeking a retraction of a study published in a medical journal last month that found heart-defibrillator wires made by the company were responsible for at least 20 deaths, citing inaccurate facts and biased analysis.
In the Heart Rhythm Journal last month, prominent cardiologist Robert G. Hauser wrote that separate Riata leads, used in the company's implantable defibrillators, are responsible for the deaths because of "high-voltage failures." Hauser said the deaths allegedly caused by Riata malfunctions were about nine times greater than a competing lead called the Quattro Secure made by Medtronic Inc. (MDT).
The medical device company had previously said Hauser's article contains several errors and argued that the Quattro Secure contains different materials from those of Riata.
On Friday, St. Jude said Hauser's research substantially undercounted total deaths on the U.S. Food and Drug Administration's device database, called MAUDE, for Quattro Secure, which resulted in errors comparing Riata leads to the Quattro Secure lead. The company said its independent search of the MAUDE database found 377 reports of deaths involving Quattro Secure leads, while Hauser reported 62. The company's analysis of Riata lead events in the database found 74 deaths, while Hauser reported 71.
St. Jude also said Hauser's analysis of "lead-related" deaths is biased against companies that are more transparent in reporting on device malfunctions and said its comparison of Riata leads to Quattro Secure is "flawed," given the devices' different materials. St. Jude also said the method of the study, using MAUDE reports to compare devices, "is not appropriate," noting the FDA site says the data are "not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."
Hauser wasn't immediately available to respond to a call for comment.
The Riata leads are no longer on the market but are still implanted in about 128,000 patients world-wide. The U.S. Food and Drug Administration has termed the defibrillator issues a Class I recall, which applies to grave dangers like chance of death.
On Wednesday, St. Jude said that it would stop selling its QuickSite and QuickFlex left-ventricular leads used to connect cardiac resynchronization therapy devices to the heart, following reports of wires wearing through their silicone covering. Cardiac resynchronization therapy devices are used to help the heart beat more efficiently, while defibrillators are designed to deliver life-saving shocks when needed.
St. Jude shares closed at $40.97 Thursday and are up 19% since the start of the year.
-By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; firstname.lastname@example.org