FDA Approves St. Jude Medical’s New CRT Software for Managing Heart Failure Patients

St. Jude Medical, Inc., has achieved U.S. FDA approval and announced the launch of its SyncAV™ CRT software which it says will enhance its already comprehensive cardiac resynchronization therapy (CRT) portfolio.


For patients suffering from heart failure, CRT technology resynchronizes the lower chambers (ventricles) of the heart by sending uniquely programmed electrical impulses to stimulate each ventricle to beat in sync to offer improved cardiac performance. St. Jude Medical has introduced innovative solutions to enhance its CRT product portfolio to improve the care of the approximately 23 million people worldwide afflicted with congestive heart failure. While studies have shown that CRT can improve outcomes and the quality of life for many patients with heart failure, some patients do not respond optimally to traditional CRT, leaving physicians with limited options to improve their clinical outcomes for their patients. The latest heart failure offerings by St. Jude Medical will provide physicians and patients additional options that can help maximize the therapeutic effects of CRT.

SyncAV™ CRT software is designed to build upon St. Jude’s first-to-market MultiPoint™ Pacing technology. Its algorithm is designed to function independently or in conjunction with MultiPoint Pacing Technology to address and effectively treat heart failure patients, some of whom are not responsive to other pacing options. The technology, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition, also provides physicians with the opportunity to further improve treatment of patients who have responded positively to traditional CRT. By allowing physicians to activate SyncAV CRT independently or with MPP technology, the software provides physicians additional options to individually optimize CRT settings for their heart failure patients, many of whom have resynchronization needs that can vary widely depending on their disease.

Physician comments

“The SyncAV software used alone or with MultiPoint Pacing technology offers the enhanced potential to optimize heart failure therapy for patients who previously did not respond to traditional CRT therapy,” said Dr. Adam Shapira, medical director of electrophysiology services at The Heart Hospital at Baylor, in Plano, Texas. “The SyncAV software also offers the ability for automated setup, which facilitates efficient programming both remotely via Merlin and directly in the office.”

Company comments

“St. Jude Medical has a proven dedication to continued leadership in heart failure management to help physicians manage some of their most complex patients. Approval of the SyncAV CRT technology is important for those patients who are not getting the desired response from traditional cardiac resynchronization therapy,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical.

Source: Business Wire


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