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First-in-class MitraClip receives FDA approval
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Abbott Vascular has announced today that its first-in-class, catheter-based MitraClip device has been approved by the FDA for the treatment of patients with mitral regurgitation.
The device will launch immediately in the United States.
The indication includes patients with significant degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery, which is determined by a heart team. The device is delivered via the femoral vein and, according to a press release, is associated with short recovery times and short hospital stays of 2 to 3 days.
Available research from multiple trials, published reports and registries indicates the MitraClip device demonstrates a positive safety profile, reduces mitral regurgitation, improves symptoms and reduces hospitalizations for HF, even in some of the most ill and debilitated patients, Abbott Vascular stated in the release.
“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,” Michael J. Mack, MD, director of cardiovascular research and cardiovascular medicine and director of cardiovascular surgery at Baylor Health Care System, Dallas, said in the release. “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.”
Ted Feldman
Ted Feldman, MD, FSCAI, director, cardiac catheterization laboratory and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill., said the device is a breakthrough in the treatment of severe mitral regurgitation. “It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment,” Feldman said in the release.
To date, more than 11,000 patients in more than 30 countries have been treated with the MitraClip. Abbott will continue to conduct randomized clinical research on the device, including the COAPT trial in the United States and the RESHAPE-HF trial in Europe, which will examine the impact of the therapy on the progression of HF.
Perspective
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Jason H. Rogers, MD, FACC, FSCAI
The MitraClip device is an amazing technology that allows for correction of clinically significant MR with minimal risk. As with transcatheter aortic valve replacement, there are many patients that are not currently offered surgical mitral valve correction due to excessive surgical risk. The MitraClip is revolutionary in that it is the first transcatheter device to achieve global adoption and approval for the treatment of MR, and this bodes well for the future of other transcatheter techniques for MR correction.
Of course, not every patient with MR will be eligible for the MitraClip. In the United States, therapy is limited to patients with degenerative MR at high surgical risk, which represents only about a quarter to one-third of the total potential treatment population. In addition, many patients have other anatomic criteria that may make MitraClip therapy less effective, such as leaflet calcification, advanced degeneration of the leaflets or severe LV dysfunction.
A major unknown to the future success of the MitraClip in the United States rests in how reimbursement will be determined for the procedure. The reimbursement finances are currently a break-even scenario at best. However, it is expected that corrections will come as payers recognize the remarkable benefits of this device for patients.
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