October 26, 2013 | By Anabela Farrica
The U.S. Food and Drug Administration has approved Abbot’s MitraClip, a device intended for patients with mitral valve regurgitation and for whom open-heart surgery for valve repair is deemed inadequate. Patients who find themselves in a too fragile state to endure such complex surgeries are generally treated with the available medicines and experience high rates of heart failure and rehospitalization.
The MitraClip is an implantable medical device, which can be placed in the patient’s heart via a minimally invasive procedure using a catheter inserted through the femoral vein. Several clinical trials and published reports have shown the potential of this breakthrough treatment for patients with significant symptomatic degenerative mitral regurgitation, who are at prohibitive risk for open heart mitral valve surgery. The MitraClip system has consistently demonstrated a positive safety profile, reduction in mitral valve regurgitation, improvement in symptoms and reduction in hospitalizations.
However, MitraClip found several obstacles before being approved by the FDA. This included a safety warning to European patients, a 4-year follow-up that suggested that patients treated with this device would need additional interventions and a mixed endorsement from the FDA Circulatory System Devices Panel in March with questions regarding its effectiveness. Abbott is still studying the MitraClip therapy through two randomized trials – COAPT in the United States and RESHAPE-HF in Europe – that will evaluate the impact of this treatment on the progression of heart failure.
This device was approved for commercialization in Europe in 2008 and it experienced a 50% growth in global sales in 2012. More than 11.000 patients have been treated with the MitraClip in over 30 countries. The introduction of this innovative, first-in-class device in the U.S. market is expected to generate $500 million in the long run.