St. Jude expands EnSite Precision launch in EU seeks FDA approval

St. Jude Medical (NYSE:STJ) said today it is expanding its commercial release of its EnSite Precision cardiac mapping system in the European Union, and that it is currently pursuing FDA clearance of the system.

The St. Paul, Minn.-based company’s Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options.

“We developed the EnSite Precision system with insight from world-renowned electrophysiologists to encompass leading mapping capabilities. Providing a best-in-class mapping system combining speed and detail with precision and stability allows physicians to have the information they need to treat both straightforward and complex arrhythmias,” clinical, medical and scientific affairs veep Dr. Srijoy Mahapatra said in a prepared release.

The expanded release includes a new suite of technologis including improved hardware and software features, the company said.

“The EnSite Precision system is precise, reliable, accurate and it’s fast. This is very important when it comes to the demands of today’s electrophysiologists, especially as we see more patients with complex substrate based arrhythmias. This is really what we need to push clinical electrophysiology forward to a better level of successful case execution,” Dr. Gerhard Hindricks, Director of Germany’s University of Leipzig Heart Center said in a press release.

Yesterday, St. Jude touted the 1st U.S. commercial implantations for its Quadra Assura MP cardiac resynchronization therapy defibrillator, featuring its MultiPoint pacing technology.

The MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said.

Last month the Little Canada, Minn.-based company won CE Mark approval in the European Union for 3 new Quartet left ventricular leads; in February, St. Jude said the FDA approved the MultiPoint technology for the Quadra Assura devices, plus a new set of quadripolar pacing leads called Quartet LV. St. Jude 1st won CE Mark approval for the Quadra Assura in June 2013;a CE Mark for MRI-conditional labeling followed in December 2015.

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