FDA Gives Nod to Next-Generation MitraClip System

Patrice Wendling

Disclosures

July 12, 2018

The US Food and Drug Administration (FDA) has approved what is now the third generation of the MitraClip system for transcatheter-based mitral valve repair, Abbott Vascular announced in a news release today.

"The next-generation MitraClip system provides cardiologists with advanced steering, navigation, and positioning capabilities for the clip, making it easier to use in difficult anatomies," the company writes.

The third-generation system includes the MitraClip XTR device and the MitraClip NTR device.

"Both new devices have enhancements that improve deliverability and precision. Additionally, the new MitraClip XTR device offers a second clip size with 3 mm longer arms that expand the reach of the device by 5 mm over that of the new MitraClip NTR device," Abbott spokesperson Mary Kokkinen told Medscape Medical News.

Abbott received the CE mark earlier this year of the third-generation MitraClip system for sales in Europe.

"Physicians rely on MitraClip as an alternative to surgery for patients who aren't surgical candidates and may need treatment to relieve their symptoms or to survive," Francesco Maisano, MD, an early implanter of MitraClip from the University Hospital Zurich, Switzerland, said in the release. "The enhanced MitraClip design allows for even more precise navigation, accuracy, and stability during valve repairs, which may be important when treating people with more complex or advanced valve disease."

"Abbott engineers designed these enhancements based on feedback from doctors to improve device delivery and to treat more types of cases and anatomies," Michael Dale, vice president for Abbott's structural heart business, said in the release.

The MitraClip EXPAND study is prospectively evaluating the safety and performance of the new MitraClip system in a real-world cohort of about 1000 patients, with interim results expected later this year.

MitraClip gained initial approval in the US in late 2013 for patients with symptomatic degenerative mitral regurgitation considered at high risk for mitral-valve surgery.

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