The head of the company which manufactured the now-recalled Riata and Riata ST cardiac defibrillator leads is backing down from heated words the company has used recently to critique a new study which linked the devices to at least 22 deaths.
St. Jude Medical CEO Daniel Starks has slammed a study appearing in the journal HeartRhythm which attributed his company’s defective cardiac defibrillator leads to a considerable amount of patient deaths. St. Jude took umbrage not with the deaths linked to its devices but to the lack of deaths attributed to a competitive and also-recalled lead, Medtronic’s Quattro.
The study appearing in the journal was conducted by a prominent Ohio cardiologist, Dr. Robert Hauser, who’s published numerous studies and conducted years of research on potentially dangerous medical devices, specifically those designed for the heart. In the weeks since that study was published, St. Jude has thrown a public tantrum over the results, even conducting a counter study to the published work in which it tried to attribute more than 300 deaths on the Quattro.
Perhaps the move was an attempt to deflect attention away from the deficiencies of the St. Jude Riata and Riata ST lead. The leads were recalled after numerous reports of the conductive ends of the leads, which connect an implanted cardiac defibrillator to the heart and provide necessary shocks to a heart to keep it beating or to regulate the organ’s rhythm, are likely to break free of their silicone insulation, posing grave risks to people relying on them on a daily basis.
According to a report at MassDevice.com, Starks told investors this week “Let me just start by saying that very sincerely we have a lot of respect for Dr. Hauser’s contribution over the years to raising awareness about medical device safety issues. We have far more in common than not. We are both focused on patient safety. We are both focused on getting as much accurate information about medical devices’ performance to physicians as possible to help them make the best decisions about their patients. “