FDA News

FDA approves next-generation device for transcatheter mitral valve repair

Abbott announced that the FDA has approved a next-generation version of its transcatheter MitraClip device for the treatment of patients with mitral regurgitation.

The next-generation catheter-based MitraClip system features advanced navigation, steering and position capabilities for operators to navigate through difficult anatomies, according to a company press release. The enhancements were made on previous generations to allow for more precise placement during deployment. The new system also features a second clip size with longer arms to increase the reach of the device in patients with more complex anatomies, according to the release.

“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, professor at UniversitätsSpital Zürich, 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.”

The MitraClip system was first approved in 2013 for treatment of patients with significant degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery, as determined by a heart team. The catheter-based device is delivered via the femoral vein. Now on a third generation, the transcatheter device has been used to treat more than 65,000 patients worldwide, according to Abbott.

Abbott is currently enrolling participants in the MitraClip EXPAND study, which will assess the safety and performance of the device in a real-world setting, according to the release. Researchers anticipate enrollment of approximately 1,000 patients in more than 50 centers in the United States and Europe, and interim results are expected later this year. The study is led by principal investigator Saibal Kar, MD, director of interventional cardiac research at the Smidt Heart Institute at Cedars-Sinai.

Disclosure: Maisano reports he is a consultant for Abbott and several other medical device companies.

Abbott announced that the FDA has approved a next-generation version of its transcatheter MitraClip device for the treatment of patients with mitral regurgitation.

The next-generation catheter-based MitraClip system features advanced navigation, steering and position capabilities for operators to navigate through difficult anatomies, according to a company press release. The enhancements were made on previous generations to allow for more precise placement during deployment. The new system also features a second clip size with longer arms to increase the reach of the device in patients with more complex anatomies, according to the release.

“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, professor at UniversitätsSpital Zürich, 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.”

The MitraClip system was first approved in 2013 for treatment of patients with significant degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery, as determined by a heart team. The catheter-based device is delivered via the femoral vein. Now on a third generation, the transcatheter device has been used to treat more than 65,000 patients worldwide, according to Abbott.

Abbott is currently enrolling participants in the MitraClip EXPAND study, which will assess the safety and performance of the device in a real-world setting, according to the release. Researchers anticipate enrollment of approximately 1,000 patients in more than 50 centers in the United States and Europe, and interim results are expected later this year. The study is led by principal investigator Saibal Kar, MD, director of interventional cardiac research at the Smidt Heart Institute at Cedars-Sinai.

Disclosure: Maisano reports he is a consultant for Abbott and several other medical device companies.