Image: The MitraClip clip delivery system (Photo courtesy of Abbott Vascular).
A new implantable clip helps patients suffering from degenerative mitral regurgitation who have a prohibitively high risk of complications from open-heart mitral valve surgery.
The MitraClip sytem includes three components: an 8 mm (24F) steerable guide catheter for percutaneous venous access; a clip delivery system that includes the implant attached to a highly maneuverable delivery catheter, with all controls at the proximal end; and the MitraClip device itself, a 4 mm-wide cobalt-chromium clip that is coated in polyester to promote tissue growth. The clip clamps to the mitral valve's two edges, holding them together. Since the heart beats normally during the procedure, the procedure does not require a heart-lung bypass machine.
Among the benefits of the device are a positive safety profile, reduction in mitral regurgitation, favorable left ventricular remodeling, improvement in patient symptoms, and reduction in hospitalizations for heart failure (HF). The clip can be used is magnetic resonance imaging (MRI) systems with a magnet strength of up to 3 Tesla. The MitraClip sytem is a product of Abbott Vascular (Abbott Park, NJ, USA), and has been approved by the US Food and Drug Administration (FDA).
“FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives,” said Chuck Foltz, senior vice president of Abbott Vascular. “We look forward to making this technology available to specialized centers in the US with multidisciplinary 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."
“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, MD, director of cardiovascular research and surgery at Baylor Health Care System (Dallas, TX, USA). “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.”