MitraClip Heart Valve Repair Device Receives FDA Approval

The US Food and Drug Administration (FDA) today approved an updated version of Abbott's MitraClip heart valve repair device, which serves as an alternative to open heart surgery. The catheter-based system is used to repair mitral regurgitation (MR), a condition in which the mitral valve flaps close imperfectly, allowing blood to flow back into the heart.

"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," said Francesco Maisano, MD, Professor at UniversitätsSpital Zürich, Switzerland, who was an early implanter of MitraClip, in a statement.

MitraClip offers a minimally invasive alternative for patients who may not be eligible for the standard-of-care heart surgery due to advanced age, frailty, or multiple comorbidities.

This version of the MitraClip improves upon the steering, navigation, and positioning abilities, making it easier for cardiologists to use in difficult anatomies. The system also provides a second clip size for greater reach while repairing the mitral valve. MitraClip was initially approved by the FDA in 2013.

"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," said Maisano.

Treatment with the repair device provides patients with nearly immediate symptom relief and treated patients are able to leave the hospital 2 days following the procedure on average.

"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," said Michael Dale, vice president for Abbott's structural heart business.

An ongoing clinical study, MitraClip EXPAND, is being led by Saibal Kar, MD, director of Interventional Cardiac Research at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, California. The study will enroll about 1000 patients across 50 centers in the US and Europe. Preliminary results are expected later in 2018.