FDA Approves Abbott's Next-Generation MitraClip Device

July 12, 2018—Abbott Vascular announced approval from the FDA for the company's third-generation MitraClip transcatheter heart valve repair device. Abbott received European CE Mark approval for the device earlier this year.

According to the company, the next-generation MitraClip system provides advanced steering, navigation, and positioning capabilities for the clip, making it easier to use in difficult anatomies. The enhanced system is designed to allow for more precise placement during deployment, resulting in more predictable procedures, and additionally offers a second clip size with longer arms that expands the reach of the clip-based device. The additional clip size is designed for mitral valve repair treatment of patients with more complex anatomies.

Professor Francesco Maisano, MD, commented in Abbott's announcement, "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. 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 company advised that it recently began enrollment in the EXPAND clinical study, which is a prospective study evaluating the safety and performance of the new MitraClip system in a contemporary real-world setting.

EXPAND Lead Investigator Saibal Kar, MD, who is Director of Interventional Cardiac Research at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, California, treated the first patient enrolled in the trial. EXPAND will enroll approximately 1,000 patients in more than 50 centers across the United States and Europe. Interim results from the study are expected later this year, stated the company.