Abbott secures FDA approval for new MitraClip device

16 July 2018 (Last Updated July 16th, 2018 11:38)

Abbott has secured the US Food and Drug Administration (FDA) approval for the use of its third generation MitraClip heart valve repair device to treat a leaky mitral valve.

Abbott has secured the US Food and Drug Administration (FDA) approval for the use of its third generation MitraClip heart valve repair device to treat a leaky mitral valve.

The transcatheter clip-based therapy eliminates the need for open-heart surgery. Abbott designed the next-generation device to feature advanced steering, navigation and positioning capabilities.

These new features are intended to allow easy usage in difficult anatomies. The new system also facilitates more accurate placement while deploying in mitral valve repair procedures.

“The device is said to provide almost instant relief of symptoms and patients are discharged from the hospital after two days, on average.”

The next-generation device also comes with a second clip size with longer arms, expanding its reach as well as enabling treatment of patients with more complex anatomies.

Abbott structural heart business vice-president Michael Dale said: “Abbott engineers designed these enhancements based on feedback from doctors to improve device delivery and to treat more types of cases and anatomies.

“We’re committed to helping people with mitral regurgitation return to living their best lives, and these advances will enable doctors to treat even more patients without surgery.”

MitraClip uses a degenerative mitral regurgitation approach for treatment and is delivered through a catheter to the heart which is inserted via a blood vessel in the leg.

The device is said to provide almost instant relief of symptoms and patients are discharged from the hospital after two days, on average.

Earlier this year, Abbott obtained CE-Mark for the next-generation device to be commercialised in the European Union and other countries accepting the regulatory approval.

The company is currently assessing the new MitraClip device’s safety and performance in a prospective clinical study being conducted in a contemporary real-world setting.

This MitraClip EXPAND study is designed to recruit around 1,000 subjects at more than 50 centres in the US and Europe, with its interim data expected to be available later this year.