Abbott (NYSE:ABT) subsidiary St. Jude Medical can’t escape a product liability lawsuit brought over its recalled Riata defibrillator leads, a federal judge in California ruled this week. St. Jude pulled the silicone-coated Riata and Riata ST leads in 2010 after finding that some of the internal conductors had worn through their insulation, a failure that […]
Cardiac Rhythm Management
Boston Scientific warns on fluke S-ICD death
Boston Scientific (NYSE:BSX) last month alerted physicians after learning of a fluke incident involving its S-ICD pacemaker, in which a patient died when the device’s memory was corrupted by radiation. In a June letter to physicians, Marlborough, Mass.-based Boston Scientific wrote of “a single, isolated S-ICD event that resulted in a device-related patient death in May […]
Medtronic’s Micra leadless pacer passes space test
Medtronic‘s (NYSE:MDT) nano-sized Micra pacemaker was operating as expected after a 13-minute trip into space, the world’s largest medical device maker said last week. The device was tested as part of Cubes in Space, a private education program that partners with the National Air & Space Administration to encourage students and educators to engage in […]
Medtronic touts cost, treatment data on CRT devices
Medtronic (NYSE:MDT) today touted data showing that a pair of algorithms improved treatment and lowered costs for patients treated with its cardiac resynchronization therapy devices. The Fridley, Minn.-based medical device giant said its AdaptivCRT and EffectiveCRT algorithms lowered costs and improved therapy delivery in heart failure patients with atrial fibrillation. Results from 1 of 3 analyses […]
SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA […]
Ex-Medtronic CEO Hawkins backs CardioNXT in $2m round
A former CEO of Medtronic (NYSE:MDT) and a well-known medical device industry veteran got in on a $2.1 million funding round for CardioNXT, which is developing new tools to treat atrial fibrillation. Ex-Medtronic chief William Hawkins III and Zyga CEO James Bullock led the round, joined by Piedmont Capital Partners and prior backer Solas BioVentures. […]
Boston Scientific, St. Jude Medical must face University of California patent suits
Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT) subsidiary St. Jude Medical must face lawsuits brought by the University of California alleging that their ablation catheters infringe a pair of patents covering atrial fibrillation treatments. The university’s regents sued the companies last October (a similar suit was brought against AtriCure (NSDQ:ATRC) the next month, according to court documents), accusing the companies […]
HRS 2017 Roundup: Study pinpoints battery issue in Abbott’s Nanostim leadless pacer
A study of the Nanostim leadless pacemaker made by Abbott’s St. Jude Medical subsidiary pinpoints the cause of a battery depletion issue A study of the Nanostim leadless pacemaker Abbott acquired this year when it bought St. Jude Medical, presented last week at the annual Heart Rhythm Society conference, found that a battery depletion problem […]
HRS 2017: Two-year registry data on Boston Scientific’s S-ICD
Data from a long-term post-approval registry study of the S-ICD subcutaneous pacemaker made by Boston Scientific (NYSE:BSX) showed high successful implantation rates and “acceptable” short-term complication rates, researchers said today at the annual Heart Rhythm Society conference in Chicago. The study looked at data from 1,637 S-ICD patients who met the criteria for implantable cardioverter defibrillator implantation, […]
FDA approves Boston Scientific’s Resonate defibrillators
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for its Resonate line of defibrillators featuring multi-lead pacing. The Marlborough, Mass.-based medical device maker said the Resonate implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators also feature its SmartCRT technology and EnduraLife battery technology that it claims delivers twice the usable battery capacity […]
Boston Scientific launches Emblem S-ICD study for diabetics
Boston Scientific (NYSE:BSX) said yesterday that it’s launching a study of its Emblem S-ICD device in older patients with diabetes who are at risk for sudden heart attack but unsuitable for implantable cardiac defibrillators, as it seeks parallel approvals for the new indication from the FDA and the Centers for Medicare & Medicaid Services. The S-ICD, […]