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.
St. Jude Medical released new data from a trial that showed patients using its CardioMEMS HF system had a 57% reduction in mortality and 43% fewer hospitalizations related to heart failure compared to patients treated only by guideline directed medical therapy.
St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.
Remote monitoring can empower patients and lead to more fine-tuning of care while saving hospitals money and helping hospitals meet their Affordable Care Act goals. Sales of remote-monitoring devices are expected to top $32 billion this year, according to Market Research Group, and will grow at a compounded annual growth rate of 9.2% between 2014 and 2019.
St. Jude Medical is starting a trial for a device that it hopes will be the smallest FDA-approved pediatric mechanical heart valve. The device is only 15 mm in diameter; that's roughly equivalent to the length of a staple.