St. Jude nabs FDA nod for real-time pacemaker software

Hands holding a small rock shaped like a heart
A heart monitor that is silver
Courtesy of St. Jude Medical

Not even a month after earning its CE mark, St. Jude Medical's ($STJ) SyncAV CRT software has nailed down FDA approval. The software builds on St. Jude’s MultiPoint resynchronization therapy portfolio.

The SyncAV CRT algorithm is aimed at those patients that are not responsive to other pacing options. Pacing is automatically adjusted based on real-time changes in a patient's cardiac condition.

“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,” Dr. Adam Shapira, medical director of electrophysiology services at The Heart Hospital at Baylor, said in the announcement. “The SyncAV software also offers the ability for automated setup, which facilitates efficient programming both remotely via Merlin and directly in the office."

The organization presented results from its investigational device exemption clinical study on the MultiPoint Pacing technology--which included these newly approved additional techs--at CARDIOSTIM-EHRA EUROPACE 2016. Those results showed that the tech can support the need for individualization so physicians can offer the best electrical resynchronization plan for their patients.

Adding on to that, investigational device exemption clinical study results for the MultiPoint Pacing tech were presented at the Heart Rhythm Society’s 37th Annual Scientific Sessions and at CARDIOSTIM-EHRA EUROPACE 2016. This study showed that the tech met the primary endpoints for safety and efficacy.

- here's the press release

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St. Jude earns CE mark, launches new algorithm for real-time pacemaker adjustment