Health Canada grants approval for Edwards Intuity Elite valve system

1 November 2016 (Last Updated November 1st, 2016 18:30)

Edwards Lifesciences has secured approval from Health Canada for its advanced Edwards Intuity Elite valve system for surgical aortic valve replacement.

Edwards Lifesciences has secured approval from Health Canada for its advanced Edwards Intuity Elite valve system for surgical aortic valve replacement.

With the approval, the device has now become commercially available.

The Edwards Intuity Elite valve system is a rapid deployment device based on the Perimount tissue valve platform and features innovations from transcatheter heart valves.

"It has been designed to enable minimally invasive surgery and streamline complex aortic valve replacements while facilitating improved treatment option for patients with aortic valve disease."

The Perimount Magna mitral valve is a pericardial tissue-based bioprosthetic device that replaces a patient’s diseased mitral valve and mimics the natural mitral anatomy.

Based on the Perimount valve design, the Edwards Intuity Elite valve system is fitted with mounted matching leaflets under flexible stent which reduce the commissural stress points.

It has been designed to enable minimally invasive surgery and streamline complex aortic valve replacements while facilitating improved treatment option for patients with aortic valve disease.

The device improves the implant procedure through small incisions using three guiding sutures.

Edwards Lifesciences consultant,  Institut Cardiologie de Montréal cardiac surgeon, and Université de Montréal Cardiac Surgery Training Program director Denis Bouchard said: "As an increasing number of patients present with several comorbidities, which makes aortic valve surgery more challenging, it is important to have advanced treatment options paired with a minimal access surgical approach.

"The availability of the Edwards Intuity Elite valve will facilitate otherwise complex treatment for patients requiring concomitant procedures to treat their aortic valve and other heart issues."