FDA Approves Abbott’s MitraClip

The U.S. Food and Drug Administration (FDA) has approved Abbott Laboratories’ Mitraclip medical device, designed to stop heart valve leakage in patients deemed unable to endure valve repair through open heart surgery.

The MitraClip treats mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death. It is estimated that the disorder affects about one in 10 people aged 75 and older. Those with the condition who are too frail for open-heart surgery are typically treated with medicines and have high rates of heart failure and rehospitalizations.

The Mitraclip repairs the mitral valve without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. Patients undergoing Mitraclip treatment typically experience short recovery times and short hospital stays of two to three days, claims Abbott.

“We think longer term in the U.S., (Mitraclip) could be a $500 million product,” said RBC Capital Markets analyst Glenn Novarro. “This approval is sooner than we thought. It’s a pleasant surprise.”

Novarro said the timing of the FDA green light was excellent as it came just ahead of a major U.S. medical meeting for interventional cardiologists where Abbott will be able to showcase the device.

A panel of advisers to the FDA in March voted 5-3 to recommend approval of the implantable heart device. Some panel members questioned whether Mitraclip would be effective.

Meanwhile, in 2008, Mitraclip received the CE mark for marketing in the European Union. According to Abbott, international sales are running at about $30 million a quarter, with sales growth at about 50 percent over 2012.

“As cardiac surgeons, we see patients with severe mitral regurgitation who we 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,” said Michael Mack, M.D., director of cardiovascular research and cardiovascular medicine and director of cardiovascular surgery at Baylor Health Care System in Dallas, Texas. “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.”

U.S. sales are likely to grow slowly at first as the company seeks reimbursement for the device, primarily from the Medicare healthcare program, and as more physicians are trained in its use. The Mitraclip is implanted using a minimally invasive procedure in which it is threaded by catheter through a vein into place in the heart to stop the leak.

There are currently 50 centers in the United States that have experience with the device through clinical trials. That number is expected to double over the next year, John Capek, Abbott’s head of medical devices, told Reuters. There are 20,000 to 30,000 patients in the United States who would likely qualify for Mitraclip implantation, Capek said.

Abbott continues to conduct clinical trials of the MitraClip therapy through two prospective, randomized trials—COAPT in the United States and RESHAPE-HF in Europe—that will evaluate the impact of Mitraclip treatment on the progression of heart failure. The studies also will generate important clinical and economic data that may support development of treatment guidelines, expanded indications and reimbursement.

Abbott Labs is based outside Chicago, Ill. The company makes medical technology for a range of markets including diabetes, vascular, and diagnostics.