Abbott has obtained US Food and Drug Administration (FDA) approval for its first-in-class, catheter-based MitraClip therapy, designed for patients with significant mitral regurgitation (MR) who have no surgical treatment options to improve their quality of life.
With FDA approval, the MitraClip device will be immediately available in the US, providing physicians with a new treatment option for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery.
MR is a condition involving the mitral valve of the heart no longer functioning properly, leading to a backward flow of blood.
Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart.
Abbott's MitraClip repairs the mitral valve without the need for an invasive surgical procedure.
Abbott's MitraClip therapy is designed to reduce MR and provide clinical and quality-of-life benefits for patients suffering from the debilitating symptoms of significant MR by clipping together a portion of the leaflets of the mitral valve.
The device is delivered to the heart through the femoral vein, a blood vessel in the leg.
The company believes that MitraClip therapy results in better patient outcomes since patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays of two to three days.
Baylor Health Care System cardiovascular surgery director Dr Michael Mack said as cardiac surgeons, they see patients with severe mitral regurgitation who they can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life.
"With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life," Dr Mack said.
Abbott reported that more than 11,000 patients in more than 30 countries have been treated with the device.
The company also reported that it has clinical data backing its safe use dating back to 2003.
Ttwo separate prospective randomised trials, COAPT in the US and RESHAPE-HF in Europe, will continue to evaluate the device as a treatment for heart failure.
According to the company, both studies are currently enrolling patients and the data from these studies will be used in framing treatment guidelines, expanded indications and reimbursement.
Abbott senior vice-president vascular Chuck Foltz said FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives.
"We look forward to making this technology available to specialized centers in the US with multi-disciplinary teams experienced in the management of patients with heart valve disease, a model that facilitates dialogue across physician specialties and provides patients with the best treatment outcomes," Foltz said.
Abbott's MitraClip System had received CE Mark in 2008 and is commercially available in Europe and other international markets, with more than 9,000 patients treated to date.
According to GlobalData estimates, the cardiac valve repairs market in the US was valued at $48.5m in 2012 and is expected to grow at a CAGR of 5.3% to reach $69m by 2019.
Image: Abbott's MitraClip device. Photo: courtesy of Abbott Laboratories.