FDA approves Boston Scientific’s Acuity X4 quad leads

Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for its Acuity X4 quadripolar leads for its cardiac resynchronization devices.

The approval marks the 1st time the Marlborough, Mass.-based company has a full quadripolar CRT system on the U.S. market. The Acuity X4 leads are designed to work with Boston’s Dynagen X4 and Inogen X4 CRT-Ds.

The medical device giant also said it started a 500-patient trial this month, Enable MRI, aimed at winning approval here and in Asia for an MR-conditional label for its already-approved lines of ICDs and CRT-Ds. Enable MRI is designed to use the Acuity X4 leads, which along with its EL extended longevity and Mini implantable cardiac defibrillators won CE Mark approval in the European Union last August for an MR-conditional label.

“We continue to enhance patient care with the launch of the uniquely designed Acuity X4 leads, which allow for optimal placement of pacing electrodes to improve the performance of CRT devices,” cardiac rhythm management CMO Dr. Kenneth Stein said in prepared remarks. “Additionally, through our pursuit of MRI-conditional labeling, we maintain our commitment to bring new benefits to patients who currently have 1 of our devices or will receive 1 in the future.”

Today the company said the FDA nod for the Acuity X4 wwas based on the 764-patient Navigate X4 study, which Boston said met its primary safety and efficacy endpoints at 6 months.

“Data collected in the Navigate X4 study demonstrate that these leads are safe and effective for use with CRT devices,” said principal investigator Dr. Suneet Mittal, of Ridgewood, N.J.’s Valley Hospital Health System. “The approval is a testament to the strength of the data in this trial, which also demonstrated fast lead implant times, stable lead placement, and improved pacing performance resulting from the unique design of the Acuity X4 leads.”

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