Edwards Lifesciences (NYSE:EW) said yesterday it won Health Canada approval for its Intuitiy Elite rapid deployment aortic valve replacement system and launched the device in Canada.
Irvine, Calif.-based Edwards said the Intuity Elite valve is designed to create more time during the treatment of complex heart failure cases for procedures to treat other facets of the disease.
“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,” Edwards consultant Dr. Denis Bouchard of Canada’s Université de Montréal said in a press release.
Edwards Lifesciences won FDA approval for the rapidly deployable aortic valve in August, and won CE Mark approval in the European Union in April 2014.
Edwards said its FDA approval was backed by 1-year data from the 839-patient Transform trial of the Intuity Elite device, presented in May at the annual meeting of the American Assn. for Thoracic Surgery. The study showed reduced cross-clamp time and cardiopulmonary bypass time compared to data from the Society of Thoracic Surgeons’ adult cardiac database. New York Heart Assn. functional class improved in 73.1% of patients, according to the Transform data.
