St. Jude Medical
Leadless pacemakers from Medtronic and St. Jude Medical performed well in clinical trials, setting the stage for an exciting race for FDA approval between the two bigwigs. In a sign that the finish line is getting closer, the FDA is convening the experts on its circulatory system devices advisory panel to discuss optimal regulation of the devices.
St. Jude Medical has launched a portable version in Europe and Japan of its system to offer physicians a view from within the heart to enable physicians to make decisions during catheter-based stenting procedures. Dubbed Optis Mobile, the system is expected to offer comparable imaging as compared to the company's already marketed Optis Integrated System.
Last year St. Jude Medical agreed to pay $14.25 million to settle 950 pending legal claims related to its riata defibrillator leads. So news of a Class 1 recall of 447 Optisure defibrillator leads due to a manufacturing defect that may have introduced damage to the wires' insulation is rather unsettling.
St. Jude Medical needs to get its cardiac rhythm management unit back on track by filling gaps in the portfolio, CEO Michael Rousseau said at the J.P. Morgan Healthcare Conference in San Francisco.
St. Jude Medical is touting two studies of its neurostimulators at the North American Neuromodulation Society meeting in Las Vegas, as it seeks to bring two new forms of stimulation to the U.S., which it believes are better than traditional tonic spinal cord stimulation. Both forms of stimulation are already offered in Europe.
St. Jude Medical announced FDA approval of the Proclaim Elite Spinal Cord Stimulation System to treat chronic back pain.
St. Jude Medical touted a study in the journal The Lancet, which found that the company's CardioMEMS Heart Failure System for monitoring heart failure led to a 48% decrease in hospitalizations.
With the $3.4 billion acquisition of Thoratec complete, St. Jude Medical CEO Daniel Starks provided additional details about the company's strategy for the just-added HeartMate II left ventricular assist device during the company's Q3 earnings call. LVADS (or VADS) pumps the blood of end-stage heart failure patients.
The unexpected and unwelcome detection of reduced leaflet mobility in transaortic valve replacements is back in the spotlight thanks to a study of the phenomenon in the New England Journal of Medicine. The paper reveals some tantalizing clues about the technical issue, but it remains mysterious, and the FDA is maintaining its stance that "bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications."
St. Jude Medical revealed in an SEC filing that it has been hit by a FDA warning letter for nonconformance with the agency's Good Manufacturing Practice regulations at the Atlanta facility that makes the CardioMEMS heart failure monitor.