Health Canada Issues Licence for Expanded Indications for Evolut TAVI Platform
Evolut is now indicated in
"The expansion of TAVI to low surgical risk patients and to those with bicuspid aortic valve disease fills an important gap with a less invasive option than surgical aortic valve replacement," said Dr.
The licensed expanded indication was based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) against SAVR in more than 1,400 patients2, 3. The data showed TAVI to be an effective option, with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR. Additionally, the Evolut system demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger effective orifice area (EOAs) compared to surgery at one year.
Severe aortic stenosis occurs when the aortic valve becomes diseased (stenotic) and valve leaflets thicken and stiffen, making the heart work harder to pump blood to the rest of the body ― negatively impacting daily life. Patients with bicuspid aortic valves have only two functional valve leaflets instead of three leaflets (tricuspid). This congenital heart defect affects 1-2 percent of the general population4 and bicuspid aortic valve stenosis represents 50% percent of the severe symptomatic aortic stenosis patient population.5 Left untreated, symptomatic patients can die from heart failure in as little as two years.
"The simultaneous licensing of these indications for the Evolut platform represent major steps toward optimizing therapeutic outcomes in these dual populations of aortic valve disease patients," said Dr.
The Evolut TAVI System valve is engineered with a self-expanding nitinol frame that conforms the replacement valve to the native annulus with consistent radial force and includes an external tissue wrap that increases surface area contact with native anatomy for enhanced valve sealing.
"We are proud to further build on our patient portfolio for the Evolut TAVI system so that more Canadians can benefit from this vital, life-saving procedure," said
About Medtronic Canada ULC
Proudly serving Canadian healthcare for over 50 years, Medtronic Canada ULC (www.medtronic.ca), is a subsidiary of
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
1 | Asgar, Ouzounian et al. 2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation DOI: 10.1016/j.cjca.2019.08.011 | |||
2 | Popma JJ, et al., on behalf of the Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement With a Self-Expanding Valve in Low-Risk Patients. DOI:10.1056/NEJMoa1816885 | |||
3 | Reardon, Michael J. Evolut Surgical Replacement and Transcatheter Aortic Valve Implantation in Low Risk Patients - Evolut Low Risk. Presented at at the | |||
4 | Losenno KL, Chu MW. Bicuspid aortic valve disease. DOI: 10.1503/cmaj.121875. | |||
5 | Ward C. Clinical significance of the bicuspid aortic valve. DOI: 10.1136/heart.83.1.81 |
SOURCE Medtronic Canada ULC
© Canada Newswire, source