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 of competing devices.
The Resonate ICDs and CRT-Ds won CE Mark approval in the European Union in February, Boston Scientific said.
“We are changing the treatment landscape by combining industry-leading device longevity with innovative solutions that will provide clinicians with tools to manage heart failure more effectively,” rhythm management & global health policy CMO Dr. Kenneth Stein said in prepared remarks. “Our post-approval studies for the HeartLogic service, including Manage-HF, will gather additional evidence to illustrate how these alerts, which detect impending heart failure decompensation, can improve patient outcomes.”
Boston Scientific said it’s launched a trio of studies to evaluate its SmartCRT technology, which is designed to help physicians optimize cardiac rhythm therapies.
“These trials will add to the body of evidence showing CRT therapy can be tailored to individual patient characteristics at the time of implant, while adjusting device programming solutions over the life of the device without fear of adversely draining the device battery and causing unnecessary replacement procedures,” added Dr. Michael Gold, principal investigator of the Smart CRT study, of Charleston’s Medical University of South Carolina.