The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today. The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, […]
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Report: EU regulators poised to OK Abbott’s $25B St. Jude Medical acquisition
Antitrust regulators in the European Union are reportedly poised to give conditional clearance to the $25 billion merger of Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ). The European Commission has until next week to make its decision on the deal, after the companies earlier this month made concessions designed to assuage the commission’s monopoly fears. Abbott and St. Jude agreed last […]
St. Jude wins MRI nod for Proclaim Elite spinal cord stim
St. Jude Medical (NYSE:STJ) said today it won FDA approval for magnetic resonance imaging conditional labeling for its Proclaim Elite spinal cord stimulation system Patients using the company’s Proclaim Elite SCS are now cleared or full-body MRI diagnostics scans, the Little Canada, Minn.-based company said. “This MR Conditional labeling applies to both new patients and those […]
St. Jude wins CE Mark for MRI safe labeling for Quadra CRT-P
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker. The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said. […]
Abbott looks to mollify EU regulators on St. Jude Medical merger; sues Alere for breach of contract
Abbott (NYSE:ABT) made moves yesterday on a pair of pending, multi-billion-dollar acquisitions, its $25 billion merger with St. Jude Medical (NYSE:STJ) and a $6 billion union with Alere (NYSE:ALR). The European Commission said Abbott, which along with St. Jude agreed to deal some of its vascular assets to Japan’s Terumo Corp. (TYO:4543) last month, agreed to make unspecified concessions to […]
Japan approves St. Jude Medical’s EnSite, TactiCath
St. Jude Medical (NYSE:STJ) said today it won Japanese MHLW approval for its EnSite Precision cardiac mapping system and its TactiCath irrigated ablation catheter. The Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps, St. Jude said. The system […]
Report: St. Jude sold off older CRM devices after learning of battery issue
Updated: Corrected date of recall from 2015 to October 2016. St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled last month over issues with batteries failing with […]
St. Jude wins FDA nod for Amplatzer PFO occluder
St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke. Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of […]
St. Jude calls global stop to Nanostim implants over battery issues
St. Jude Medical (NYSE:STJ) said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting. The Little Canada, Minn.-based company said it pulled implants of the micro-sized, catheter-delivered Nanostim after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there […]
St. Jude Medical shareholders grudgingly approve executive tax breaks ahead of Abbott merger
Shareholders in St. Jude Medical (NYSE:STJ), who this week voted to approve its pending, $25 billion merger with Abbott (NYSE:ABT), grudgingly approved a measure to give tax breaks to its senior executives if the deal goes through. Little Canada, Minn.-based St. Jude’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax […]
St. Jude Medical’s shareholders OK $25B Abbott buyout
St. Jude Medical (NYSE:STJ) said yesterday that its shareholders voted to approve its pending, $25 billion buyout by Abbott (NYSE:ABT). Preliminary results showed that about 99% of shareholders at the annual meeting voted to OK the deal, representing about 74% of all outstanding stock. Little Canada, Minn.-based St. Jude said it plans to release the final vote […]