A team of researchers has found that St. Jude Medical’s defective Riata and Riata ST leads have directly caused 22 deaths or 31 percent of all deaths involving the lead family.Most surprisingly, the deaths were caused by electrical malfunction at high voltages — and not because of lead wires coming out of their insulation. The [...]

St. Jude Medical (NYSE:STJ) announced Friday that the U.S. Food and Drug Administration has cleared the next iteration of its Fractional Flow Reserve technology used to treat clogged arteries.The clearance allows the Minnesota medical device maker to market a new generation of PressureWire Aeris and PressureWire Certus guidewires, which have an “agile tip” whose performance [...]

  SCROLL BELOW FOR UPDATEContinuing its push to make fractional flow reserve technology the standard in treating clogged arteries through percutaneous coronary intervention (PCI), St. Jude Medical (NYSE:STJ) announced Wednesday that it is initiating a study to review the cost effectiveness of this technology in Asia. One analyst, however, is not convinced about the technology’s market [...]

It was supposed to be a closed meeting attended by doctors who had a large amount of experience dealing with patients with St. Jude Medical’s Riata leads, a defibrillator lead that recently garnered an FDA Class I advisory (recall) status due to it’s high failure rate. Only 55 doctors and a few industry personnel were [...]

As the market for cardiac rhythm management devices slows in the U.S., medical device makers have been rapidly looking at other avenues for growth.For St. Jude Medical(NYSE:STJ), one such growth opportunity comes from its highly vaunted fractional flow reserve technology, which is used in conjunction with percutaneous coronary intervention to treat patients with clogged arteries. [...]

Despite its troubles related to the Riata and the Riata ST lead recalls, St. Jude Medical CEO Daniel Starks told analysts Wednesday that the company will gain a 1 percentage point market share in the global cardiac rhythm market in 2012. The company’s CRM segment includes implantable cardioverter defibrillator and pacemaker products.In discussing the company’s [...]

The Class I recall of the two Riata defibrillator leads from St. Jude Medical (NYSE:STJ) highlighted the issue of lead abrasion and insulation, but both those leads don’t have St. Jude Medical’s Optim technology. When lead abrasion occurs, it can cause the electrical conductors inside leads to come out of the insulation.Optim is a silicone [...]

Coronary artery disease may have a new enemy.Interim results of the FAME II clinical trial sponsored by St. Jude Medical (NYSE:STJ), which treated people with coronary heart disease, were so positive that the company announced Wednesday that an independent board had asked that the trial be stopped immediately.In an interview with MedCity News following that [...]

To capitalize on growing demand from international markets, St. Jude Medical (NYSE:STJ) is launching a new MR-Conditional pacemaker in India that will allow patients implanted with such a pacemaker to undergo a full-body MRI scan safely.The Accent MRI pacemaker, among St. Jude’s roster of new innovative medical devices, is the first MR-Conditional pacemaker to allow [...]

A letter recently sent by St. Jude Medical (NYSE:STJ) to customers regarding a problem with some of the device maker’s defibrillator leads has been classified as a Class I recall — for the most dangerous or defective products — by the U.S. Food and Drug Administration.Although the medical device maker stopped selling the Riata line [...]