The MitraClip device for percutaneous repair of the mitral valve gained an indication for treating secondary (or functional) mitral regurgitation, the FDA announced.
Abbott's device had been cleared in 2013 for primary (or degenerative) mitral regurgitation. The expanded indication includes patients who have moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy.
"Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option," said Bram Zuckerman, MD, director of the FDA's Division of Cardiovascular Devices at the Center for Devices and Radiological Health, in the announcement.
Approval was based on positive COAPT trial results first reported at the Transcatheter Cardiovascular Therapeutics conference last fall. In this 614-person trial, heart failure hospitalizations over 24 months were almost halved with MitraClip placement compared with medical therapy alone.
Notably, COAPT results differed from those of MITRA-FR, a French trial released around the same time that did not show benefits to mitral repair in terms of hard outcomes.
Further analyses from COAPT, including quality-of-life findings, are expected at the American College of Cardiology meeting in New Orleans this weekend.
Procedural trends, outcomes, and readmission rates preand post
References edit a b, wan B, Rahnavardi M, Tian DH, Phan K, Munkholm-Larsen S, Bannon PG, Yan TD (November 2013). Every year, there is an additional.67 million Americans with new severe mitral regurgitation as well. Is the MitraClip available to all patients or select call the Midwife: BBC in abortion advice row groups of patients? In case you missed it, the MitraClip just received a Food Drug Administration (FDA) approval in the United States. Prohibitive risk does not mean that the patient is inoperable, but rather at such high risk that open mitral valve surgery is usually not performed. Treatment for...
I know it helped. Lim perform a MitraClip procedure a few years ago. Due to the less invasive nature of the MitraClip procedure, patients recover faster they are discharged from the hospital on average in approximately 3 days which is less than what is Tomato Juice Good for You? Benefits and Downsides occurs soothe Your Pain with This Mango CBD Oil Smoothie for patients undergoing open mitral valve surgery. Scott Lim, a leading interventional cardiologist at the UVA Advanced Cardiac Valve Center at the University of Virginia. Earlier this year, Abbott obtained CE-Mark for the next-generation device to be commercialised in the European Union and other countries accepting the regulatory approval.