FDAnews Device Daily Bulletin

BSX’s X4 CRT-D Systems Earn CE Mark

Dec. 19, 2013

Boston Scientific has received CE mark approval for its X4 quadripolar CRT-D line of products, which includes the Autogen, Dynagen and Inogen cardiac resynchronization defibrillators, Acuity leads and Acuity Pro lead delivery system.

According to the company, the X4 defibrillators offer “the largest number of pacing vector options in the industry,” helping physicians address high-pacing capture thresholds and the close proximity of the phrenic nerve to the pacing location. Acuity systems have multiple electrode spacing configurations and can better accommodate differences in patients’ anatomy, BSX says. The 3D spiral design improves contact with the heart muscle, minimizing pacing capture in nonapical placements.

In an observational study of 646 CRT-D recipients, BSX’s battery also outlasted those of competitors St. Jude Medical and Medtronic, the company says.

The X4 quadripolar CRT-D systems are investigational in the U.S. With a CE mark in hand, BSX plans to begin a global clinical trial of Acuity X4 leads, enrolling 1,000 patients across 18 countries. The trial will look at how the leads perform in patients indicated for CRT-D therapy. — Lena Freund

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