Abbott announced the launch of its catheter-based MitraClip system in Australia. The MitraClip device, which has received Therapeutic Goods Administration (TGA) approval, offers a new treatment option for patients suffering from mitral regurgitation.
This system includes a catheter-based device that is delivered to the heart through the femoral vein. It is designed to reduce significant mitral regurgitation by clipping together the leaflets of the mitral valve. Mitral regurgitation has traditionally been managed with medications, which can relieve symptoms but do not address the underlying cause of the condition, or open-heart surgery. According to Bach et al, many people who suffer from mitral regurgitation are not treated surgically because they are not referred to surgery, are not sick enough, or are too frail for an invasive procedure.
“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,” said Eric Yamen, Sir Charles Gairdner Hospital, Perth, Australia. “This therapy has the potential to improve the quality of life for many sick patients, enabling them to have a more active lifestyle.”
The first patients were successfully treated in Australia by interventional cardiologist, Eric Yamen; cardiothoracic surgeon, Jurgen Passage and echocardiologist, Christopher Finn; all from Sir Charles Gairdner Hospital, Perth, Australia.
Robert Hance, senior vice president, Vascular, Abbott, commented “Nearly 3,000 patients around the world have benefited from MitraClip treatment, and we are pleased that it is now commercially available in Australia.”
New clinical study to gather additional clinical and health-economic data
Abbott also announced the initiation of a new clinical study of the MitraClip device 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, director of the Cardiac Catheterization Laboratories, St Vincent’s Hospital, Sydney, Australia, and Jurgen Passage, cardiothoracic surgeon, Sir Charles Gairdner Hospital, Perth, Australia, will serve as the principal investigators of the study.
About the MitraClip technology and procedure
The catheter-based MitraClip device is delivered to the heart through the femoral vein. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. After treatment, patients are usually home within two to three days and have been observed to recover quickly. The safety and efficacy of the MitraClip system was evaluated in EVEREST II, the first randomised clinical trial to compare a catheter-based mitral valve device to mitral valve surgery.
The MitraClip system was CE marked in March 2008 and is commercially available in Europe, Turkey, Israel and Australia. The first-in-man clinical trial of the MitraClip system was conducted in the United States, where it is an investigational device currently under review for approval by the FDA.