St. Jude Medical suffered a rare withdrawal of the CE mark of its Portico transaortic aortic valve replacement last year and had to suspend its U.S. clinical trial for FDA approval. Now new data released from three studies at the annual EuroPCR conference in Paris should help St. Jude convince the FDA to resume that trial.
St. Jude Medical highlighted studies that demonstrate the effectiveness of optical coherence tomography during stenting procedures at the EuroPCR conference in Paris.
St. Jude Medical said in a new study that its CardioMEMS HF System can deliver improved outcomes and be cost-effective for heart failure patients who are already well-managed for their condition when they use pulmonary artery pressure monitoring.
Tracking patients who have various cardiac devices via a remote monitoring system cuts down on hospitalizations and costs, while improving patient survival. That's according to a 5-year study by St. Jude Medical of more than 90,000 patients with pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices.
The FDA has approved the Protégé MRI spinal cord stimulation system to treat chronic pain, along with the related MRI compatible leads, from St. Jude Medical. The device also offers the benefit of enabling future updates via wireless software upgrades rather than requiring its replacement to gain the benefits of new developments.
At last week's mitral valve disease conference in New York City, Italy's Sorin Group presented data showing improved outcomes with its annuloplasty ring in heart failure patients, as compared to the results from patients with rings made by rivals Medtronic and St. Jude Medical.
St. Jude Medical took the opportunity on its April 22 earnings call to flesh out the logic and expectations behind its purchase of Spinal Modulation for a total of at least $215 million (plus undisclosed approval and revenue milestones) that was revealed earlier this week. Neuromodulation is one of its three pillars for achieving 4% to 5% revenue growth this year--and the company anticipates that in 2016 neuromodulation will be even stronger.
St. Jude Medical will buy portfolio company Spinal Modulation. The startup has submitted a PMA for its Axium Neurostimulator System to treat chronic pain. St. Jude will pay up to $175 million upfront with additional undisclosed payments upon FDA approval of the Axium system and with the achievement of undisclosed revenue targets.
Medtronic has officially joined the European leadless pacemaker market thanks to the CE-mark approval of its Micra Transcatheter Pacing System. It is one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.
As one of the country's large exporting industries, the medical device industry has been hit by the appreciation of the U.S. dollar, which makes exports more expensive and imports cheaper.