Where medication fails, MitraClip saves lives, reduces hospitalizations and dramatically improves quality-of-life in treating advanced heart failure patients with secondary mitral regurgitation. With FDA approval for secondary mitral regurgitation treatment, MitraClip can help 2-3 times as many patients.1 MitraClip is the only mitral device approved to treat advanced heart failure patients with significant secondary mitral regurgitation (MR). Prior to this approval, the standard of care for most heart failure patients with severe MR was to manage their symptoms with medication, which doesn't treat the underlying cause of MR, a leaky mitral valve. In over a decade of use, more than 80,000 people worldwide have been treated with MitraClip. The FDA's decision means it's now in position to help many thousands more. How MitraClip Works The heart is a pump, sending oxygenated blood throughout the body. Each valve has a purpose to keep blood moving to or from the heart, so the body can operate as intended. Mitral regurgitation occurs when blood backs up in the heart, from either a leaky mitral valve or from valve leaflets that cannot close due to the left chamber of the heart being enlarged from advanced heart failure. Through a minimally invasive procedure, MitraClip restores normal function to the leaflets of the mitral valve by clipping them together, relieving MR and allowing the heart to pump blood more efficiently throughout the body. A Groundbreaking Study with Life-Changing Results For people living with heart failure, the ones who need the most help are often the least capable of receiving it, because of advanced age or frailty or other complicating factors. But in September of 2018, we saw the results of the landmark COAPTTM Trial, which looked at 614 advanced heart failure patients living with moderate-to-severe and severe secondary mitral regurgitation. The participants' median age was just over 72 years and more than 60 percent were male. And the secondary MR they're living with is a tricky prognosis that's difficult to diagnose and manage. As Neil Moat, chief medical officer for our Structural Heart business says, 'Since severe secondary MR is extremely difficult to manage and associated with a very poor prognosis, people have historically had few options. The secondary MR indication for MitraClip opens new doors for these ailing patients and improves both their symptoms as well as their chance for survival.' MitraClip offers a minimally invasive — and safe and effective — alternative that met both of the trial's primary endpoints and all 10 secondary endpoints. The COAPT Trial shows: MitraClip provides almost immediate symptom relief. On average, people left the hospital after two days. When combined with medical therapy, MitraClip significantly reduced hospitalization in heart failure patients through two years compared to medical therapy alone, dropping from nearly 68 percent to just under 36 percent, annually. One year out from the procedure, freedom from device-related complications was nearly 97 percent, exceeding the study's goal of 88 percent. Two years out, people with MitraClip and medical therapy saw a sharp reduction in all-cause mortality compared to those with medication alone, from just over 46 percent of patients in the control group to just over 29 percent in the device group. And for patients experiencing significant MR: For MitraClip recipients, severity of their mitral regurgitation was greatly reduced. And those same patients saw a 43 percent reduction in death or first heart failure hospitalization. Not surprisingly, MitraClip provided a substantial improvement in patients' perception of their health status as measured by the KCCQ quality-of-life score. Now Approved in the U.S. to Help Many More The FDA's secondary MR indication for MitraClip means a viable potential treatment for secondary MR is available where it wasn't before. That's good news for the many patients who may benefit from MitraClip to treat secondary MR and heart failure in addition to those being treated for the primary form of the disease, commonly associated with age. 'This is truly a significant approval for a device that has already helped many tens of thousands of people avoid surgery and get back to their lives,' said Michael Dale, vice president of Abbott's structural heart business. 'Physicians now have a new option to treat advanced heart failure patients with the secondary form of the disease – helping them stay out of the hospital while improving survival.' Our work in mitral therapy will continue to grow and expand, with MitraClip being used to treat patients in more than 50 countries. It's the kind of innovation the world expects from a leading health technology company and recognized leader.