April 4, 2011 – A new system for treating mitral regurgitation (MR) has been launched in Australia. The MitraClip device, by Abbott, has received Therapeutic Goods Administration (TGA) approval and offers a new treatment option for patients.
Chronic, severe MR is often associated with heart failure and can result in death if left untreated. The system represents an important therapeutic option for patients with this debilitating disease, many of whom may have no other treatment options.
The first patients were successfully treated in Australia by a multidisciplinary team including interventional cardiologist Eric Yamen, M.D.; cardiothoracic surgeon Jurgen Passage, M.D.; and echocardiologist Christopher Finn, M.D. All are at Sir Charles Gairdner Hospital in Perth.
"The availability of the MitraClip system provides physicians with a safe, minimally invasive treatment for mitral regurgitation that may provide new hope for many people for whom surgery is not an option," Yamen said. "This therapy has the potential to improve the quality of life for many sick patients, enabling them to have a more active lifestyle."
The system includes a catheter-based device that is delivered to the heart through the femoral vein in the leg. The therapy is designed to reduce significant MR by clipping together the leaflets of the mitral valve, one of the four valves of the heart. Significant MR is a debilitating condition in which the heart's ability to function continues to deteriorate over time, and may lead to irregular heartbeats, heart failure, stroke, heart attack or death. The condition traditionally has been managed with medications, which can relieve symptoms but do not address the underlying cause of the condition, or open-heart surgery. Many people who suffer from MR are not treated surgically because they are not referred to surgery, are not sick enough or are too frail for an invasive procedure.
In addition, a new clinical study of the device has been initiated that will enroll up to 150 patients at up to 15 sites in Australia and New Zealand. The primary objective of the single-arm, prospective trial is to gather real-world clinical and health-economic outcome data to evaluate the long-term safety, efficacy and economic value of the MitraClip system. Patients in the study will be evaluated at discharge and after 30 days and six, 12 and 24 months following the procedure.
Patients will be selected for inclusion in the study by a multidisciplinary team involving specialists in interventional cardiology, cardiac surgery and echocardiology.
David Muller, M.D., director of the cardiac catheterization laboratories at St. Vincent's Hospital in Sydney, Australia, and Jurgen Passage, M.D., cardiothoracic surgeon at Sir Charles Gairdner Hospital in Perth, Australia, will serve as the principal investigators of the study.
For more information: www.abbott.com