Abbott Vascular has announced that it will immediately launch the MitraClip, which is a minimally invasive device for the management of significant symptomatic degenerative mitral regurgitation in patients who are at prohibitive risk for mitral valve surgery, on to the USA market now that it has received FDA approval for the device.
According to a press release, multiple trials, published reports and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms and reduction in hospitalisations for heart failure. More than 11,000 patients in more than 30 countries have been treated with the MitraClip device.
“MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure and death,” says Ted Feldman, director, Cardiac Catheterization Laboratory and The Mr and Mrs Charles R Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, USA. He adds: “Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time. It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment.”
The press release reports that Abbott continues to conduct clinical trials of the MitraClip therapy through two landmark, prospective, randomised trials—COAPT in the USA 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. Both studies are currently enrolling patients.