The ruling by Health Canada now allows sale of the MitraClip throughout the country; the MitraClip was approved by the FDA for use in the United States last October.
In the road to U.S. approval, the MitraClip device was the topic of intense discussion by the FDA panel tasked with judging its safety, efficacy, and risk-benefit ratio. A little over a year ago, the panel voted 8-0 in favor of safety for use in patients who meet the criteria, i.e. those at prohibitive risk for open surgery. However, for efficacy, the vote split 50-50 and the head of the panel broke the tie...but it was against efficacy. So the MitraClip was judged definitely safe, but effectiveness was not clear. Finally, the vote for a favorable risk-benefit ratio was 5-3 in favor, not an overwhelming endorsement, but the panel, and ultimately the FDA itself, was swayed by the surgeons, interventionalists, and patients who testified at the panel that there was significant benefit for those who otherwise had no options.
As MitraClip investigator Dr. Ted Feldman has previously commented:
And to bring us up-to-date, a spokesperson for Abbott Vascular stated in an email to Angioplasty.Org that so far "more than 14,000 patients in more than 30 countries have been treated with the device, which has demonstrated a positive safety profile through multiple trials, published reports and registries of patients."
Abbott's First-of-Its-Kind MitraClip® Device Now Approved in Canada
Treatment with Minimally Invasive Device Can Improve Symptoms, Disease Progression and Quality of Life for People with Mitral Valve Disease Who Are Too High Risk for Surgery
April 30, 2014 -- Montreal -- Abbott today announced that its revolutionary, catheter-based MitraClip® therapy has received Health Canada approval, providing physicians in Canada with a breakthrough treatment option that can significantly improve symptoms, disease progression and quality of life for certain people with a heart condition called 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. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Treatment with the MitraClip device can be effective in reducing the symptoms associated with severe MR, such as shortness of breath and fatigue, which may help people lead a more active lifestyle.
MR is a common condition, affecting an estimated one in 10 people aged 75 and above.[1] Severe MR can be a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure. Open heart mitral valve surgery is the standard-of-care treatment, but many patients are too high risk for an invasive procedure. Medications for the condition are limited to reducing symptoms and do not have the ability to stop the progression of the disease.
"As cardiac surgeons, we often see patients with mitral regurgitation who are too frail or sick for mitral valve surgery and are severely limited in their daily activities due to their disease," said Dr. Gideon Cohen, M.D., Ph.D., FRCS, Chief, Division of Cardiac Surgery, Sunnybrook Health Sciences Centre, University of Toronto. "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."
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.
"Patients treated with the MitraClip device can have dramatic improvements when their mitral regurgitation is reduced and their heart can pump blood more efficiently," said Dr. Anita Asgar, M.D., FRCPC, FACC, Cardiologist, Montreal Heart Institute. "Many of these patients have suffered with mitral regurgitation 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."
Abbott's MitraClip repairs the mitral valve without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once the device is implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays of two to three days.[2]
Dr. Charles A. Simonton |
"Health Canada approval of MitraClip marks an important milestone in bringing this first-of-its-kind therapy to many patients who have no other viable treatment options for their mitral regurgitation," said Charles A. Simonton, M.D., FACC, FSCAI, Divisional Vice-President, Medical Affairs, and Chief Medical Officer, Abbott Vascular. "We look forward to making this technology available to specialized centers in Canada with teams of heart doctors experienced in the management of patients with mitral valve disease, with the aim of providing people with the best possible treatment options."
About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.
Abbott
Abbott (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.
In Canada, Abbott has approximately 1,500 employees working in manufacturing, distribution and logistics, as well as sales and marketing. Primary locations in Canada are in Montreal, Markham, Mississauga, Ottawa, Victoriaville and Edmonton.
Abbott's news releases and other information are available on the company's web sites at www.abbott.ca and www.abbott.com. Connect with us on Twitter at @AbbottNews.
[1] Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. http://www.ncbi.nlm.nih.gov/pubmed/16980116
[2] Data on file at Abbott; Rogers, JH, Franzen, O. Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation. European Heart Journal (2011) 32, 2350–2357.
