
MASSDEVICE ON CALL — St. Jude Medical (NYSE:STJ) dialed back the rhetoric against prominent cardiologist Dr. Robert Hauser, whose linking the device titan’s recalled Riata defibrillator leads with 22 deaths from internal electrical problems was published in the Heart Rhythm Journal last month.
"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," chairman, president & CEO Daniel Starks said during a conference call with investors today. "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. "
Starks has previously gone on the record calling out Hauser’s research, going so far as to call criticisms of the Riata recall a "whisper campaign" forged by rivals looking to gain ground in the slumping cardiac rhythm management arena by casting doubt on St. Jude’s newer Durata leads.
"This has become a topic of competitive marketing," CEO Daniel Starks told the New York Times last week. "We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts."
Since then, the company has toned things down while maintaining that Hauser’s report was inaccurate at best, MedCity News reported..
"Unfortunately the Heart Rhythm Journal published the manuscript submitted by Dr. Hauser contained important errors that were not identified during the peer review process and were widely circulated and really this just put everyone in an awkward position," Starks said today. "Keeping in mind that this information is about life-saving medical devices, it’s important for us to continue to inform patients with the most accurate information that we can and continue to inform physicians. So we are now working with the Heart Rhythm Journal to address this issue in a way that will be most helpful for patients and physicians and we think that’s important for us to do so."
Stryker’s New York plant goes up for sale
Stryker‘s (NYSE:SYK) Orchard Park, New York, manufacturing facility, from which the device maker cut 160 jobs in efforts to cut costs ahead of the 2.3% medical device tax, is up for sale for $3.9 million, the Buffalo News reported.
Device recalls raise doubts about industry’s commitment to safety
St. Jude Medical’s Riata defibrillator lead ruckus has some questioning whether the medical device industry put any stock in its own promises to stay vigilant and keep a closer eye on potential device flaws following the debacle surrounding Guidant’s 2005 defibrillator recall, the New York Times reported.
Mobile medical app makers clash with FDA requirements
Mobile medical app developers, often coming from the relatively unregulated software world, are facing a "culture clash" when learning the ropes at the FDA, which decided last year that apps that claim to diagnose or treat a medical condition require agency review, Politico reported.
Medtronic unveils 2 new studies and launches new spine surgery tools
Medtronic (NYSE:MDT) unleashed a clutch of news, including positive 2-year findings for its Endurant AAA stent graft, the launch of a new global drug-eluting balloon study and launched its new Powerease system of electronic instruments for spine surgery.