Abbott Vascular's MitraClip Approved in Canada

April 30, 2014—Abbott Vascular announced that its catheter-based MitraClip therapy has received Health Canada approval for the treatment of mitral regurgitation (MR). The MitraClip device has been approved for people with degenerative MR who are too high risk for mitral valve surgery based on evaluation by a team of heart doctors, including a heart surgeon. Treatment with the MitraClip device can be effective in reducing the symptoms associated with severe MR, such as shortness of breath and fatigue, advised the company.

Abbott Vascular noted that multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure.

In the company’s press release, Gideon Cohen, MD, commented, “As cardiac surgeons, we often see patients with MR who are too frail or sick for mitral valve surgery and are severely limited in their daily activities due to their disease. The MitraClip system provides a new catheter-based, minimally invasive treatment option for many of these patients, addressing an important unmet need and helping them regain their quality of life.” Dr. Cohen is Chief of the Division of Cardiac Surgery at Sunnybrook Health Sciences Center at the University of Toronto in Toronto, Ontario, Canada.

Anita Asgar, MD, a cardiologist at the Montreal Heart Institute in Montreal, Quebec, Canada, added, “Patients treated with the MitraClip device can have dramatic improvements when their MR is reduced and their heart can pump blood more efficiently. Many of these patients have suffered with MR without access to other treatment options, making the approval of the MitraClip device in Canada tremendous news, as it offers a new alternative to these patients.”