A few weeks after the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-defibrillators, the company hasn't wasted any time moving ahead. The German cardiac device company said it performed initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.
St. Jude Medical gained a pivotal CE mark for two next-generation lines of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, advancing in Europe even as its rivals win U.S. approval for competing devices.
Medtronic is padding its fleet of U.S.-approved cardiac devices, winning the FDA's blessing to market new Viva and Evera implants.
Biotronik got the FDA's final approval on Lumax 740 DX, a first-in-class single-lead ICD designed to treat atrial fibrillation that the company says could vastly improve care for patients.
Medtronic snagged CE mark approval for its Evera line of ICDs, planning to launch devices the company says offer increased longevity, lower risk of shock and a 30% reduction in skin pressure.
Biotronik is touting positive data for its Home Monitoring device, reporting that its tech, designed to keep tabs on ICD patients, reduces inappropriate shocks by 52% compared to traditional in-office follow-ups.
With all the worry that people with pacemakers or implanted cardioverter defibrillators can't have an MRI, a new study concludes the procedure may be fine for these patients anyway.
Boston Scientific has taken another step toward turning around its flagging defibrillator sales, closing a $150 million deal for Cameron Health and acquiring that company's S-ICD device.
The FDA has given its blessing to Boston Scientific's ($BSX) INCEPTA, ENERGEN and PUNCTUA CRT-Ds and ICDs to treat heart failure and sudden cardiac death. In a release, the company touts the devices'
Boston Scientific (NYSE: BSX) is alerting doctors that three of its implantable defibrillators have a defect that can prevent them from working properly. A magnetic switch on the defibrillators can