Medtronic announced a large voluntary recall of its Shiley neonatal and pediatric tracheostomy tubes is underway due to a wider angle bend among affected models than in those manufactured after Nov. 29, 2012. It has suspended shipments of the faulty tubes.
Analysts said Edwards Lifesciences widened the lead over Medtronic with the FDA approval its Sapien 3 TAVR, but Minnesota's industry bigwig struck back just days later, receiving approval of a third-generation version of its own TAVR, the CoreValve Evolut R.
Medtronic reports early pivotal data for tiny leadless pacemaker with U.S. launch slated in a year or so
Cardiac Rhythm & Heart Failure is one of Medtronic's faster growing businesses, driven in part by the launch of tiny subcutaneous heart monitor Reveal Linq. The medical device giant expects that the launch of supersmall leadless pacemaker Micra Transcatheter Pacing System could help it to keep that revenue growth momentum going.
Medtronic continued its shopping spree, acquiring Aptus Endosystems for $110 million to get its hands on aortic aneurysm repair technology. The June 19 move comes one day after it obtained the rights to acquire another aortic aneurysm player, as well as cardiology company CardioInsight for $93 million. So that's three transactions over two days for the medical device behemoth.
Undisputed medical device heavyweight Medtronic has been busily wheeling and dealing with tiny startups this year--perhaps putting to rest industry concern that the merger with Covidien would put a damper on strategic backing for private med tech companies as a key player was eliminated.
Germany's Biotronik announced the publication of a study in HeartRhythm that shows the MRI compatibility of its implantable cardioverter defibrillators, as it races with Medtronic to be the first to get an MRI-safe version of the cardiology device to market. The company said it has submitted the study to the FDA in support of the approval of the Iforia ProMRI ICD system.
Medtronic announced the U.S. launch of its Fortrex balloon catheter, which performs angioplasty to physically disrupt blockages so that vessels can accept therapy via an arteriovenous access point.
Medtronic said in a regulatory filing that three shareholder lawsuits against current and former executives were voluntarily dismissed.
St. Jude Medical expects that gains in the neuromodulation market will undergird an improved revenue growth rate over the next few years. Key to that strategy is the Axium Neurostimulator System to treat chronic lower limb pain. In January, the company submitted to the FDA for a PMA approval for the device. Now it's released positive superiority data for Axium as compared to a traditional spinal cord stimulation device from competitor Medtronic.
The most common weight-loss surgery is the sleeve gastrectomy, in which two-thirds of the stomach is removed to create a pouch that is roughly the size and shape of a banana without touching the intestines. Medtronic has come out with a surgical tool, the GastriSail gastric positioning system, that it says will enable surgeons to consistently size the pouch, as well as to decompress the pouch and test for leaks.