US-based Abbott Laboratories has obtained an approval from the US Food and Drug Administration (FDA) for its MitraClip device, designed to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery.
Mitral regurgitation is a life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart.
Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve.
The minimally invasive device is delivered to the heart through the femoral vein, a blood vessel in the leg.
After implantation of MitraClip device, the heart will pump blood more efficiently, thereby relieving symptoms and improving patient quality of life.
The MitraClip device showed positive safety profile, reduction in MR, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients.
It has been implanted in over 11,000 patients in more than 30 countries.
Abbott vascular senior vice president Chuck Foltz noted FDA approval of MitraClip marks an important milestone for the company as it continues to bring forward innovative therapies to help patients live better lives.
"We look forward to making this technology available to specialized centers in the U.S. 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 added.
The company continues to conduct clinical trials of the MitraClip therapy through COAPT trial in the US and RESHAPE-HF trial in Europe.
These two clinical trials have been designed to assess the impact of MitraClip treatment on the progression of heart failure and the trials will also generate important clinical and economic data that may support development of treatment guidelines, expanded indications and reimbursement.
Currently, the COAPT and the RESHAPE-HF trials are enrolling patients.
Abbott will launch the MitraClip device immediately in the US.
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.
