Healthcare company Abbott (NYSE:ABT) disclosed on Thursday the receipt of approval the US Food and Drug Administration (FDA) for the next-generation version of its leading MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery.

The leaky mitral valve, called mitral regurgitation (MR) is a serious, progressive heart disease in which the flaps of the mitral valve do not close properly, allowing blood to flow backward into the heart, leading to life-altering symptoms and severe complications and may ultimately lead to heart failure and death.

A third generation product, the transcatheter clip-based therapy has been used to treat more than 65,000 patients worldwide over the last ten years. MitraClip is delivered via a catheter to the heart through a blood vessel in the leg. The MitraClip system provides cardiologists with advanced steering, navigation and positioning capabilities for the clip, making it easier to use in difficult anatomies, added the company.

Following a CE Mark, the company can now market the next-generation MitraClip heart valve repair device in the EU and other countries that recognize this regulatory designation.

In conjunction, the company has begun enrollment in the MitraClip EXPAND clinical study to evaluate its safety and performance in a contemporary real-world setting. EXPAND will enroll 1,000 patients in 50 centres across the US and Europe and interim results are expected later this year.

According to the company, Dr Saibal Kar, MD, director of Interventional Cardiac Research at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, California, has treated the first patient and is the lead investigator of the EXPAND study.