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.
St. Jude Medical is rolling out a new interface for the display of data from its CardioMEMS heart failure monitor, which is projected to earn $286 million in 2017. Clinicians have begun accessing data collected by the implanted device via the same platform (dubbed Merlin.net) used to monitor data from the company's implantable defibrillators and pacemakers.
St. Jude Medical has received a CE mark for its latest neuromodulation technology--the Infinity Deep Brain Stimulation System to treat movement disorders. It expects to get sign-off from the FDA and to launch the system in the U.S. before year's end. The franchise is the latest addition to St. Jude's neuromodulation business, which last quarter grew faster than the company's other groups in cardiac rhythm management, atrial fibrillation and cardiovascular.
A former St. Jude Medical exec is being charged with stealing hundreds of thousands of dollars from the company for personal expenses and running off with the devicemaker's trade secrets after his position was terminated, a sordid footnote for the company as it forges ahead with new technology and puts the finishing touches on its $3.4 billion deal for heart pump maker Thoratec.
St. Jude Medical announced the new executive team that will serve under incoming CEO Michael Rousseau, beginning Jan. 1, 2016.
Jefferies equity analyst Raj Denhoy upgraded their revenue projections for St. Jude Medical's CardioMEMS Heart Failure Monitor from $140 million to $172 million in 2016 following a survey of 38 cardiologists, which found good satisfaction levels and decent uptake, but said so-so reimbursement and a high administrative burden were inhibiting wholesale adoption.