Medical technology company Medtronic has received Conformité Européenne (CE) mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system.
The approval allows the use of the system for the treatment of severe native aortic stenosis patients with low risk of surgical mortality.
The expanded low-risk indication approval is based on clinical data from the global, prospective, randomised, multi-centre Evolut Low-Risk Trial. The trial evaluated CoreValve, Evolut R and Evolut PRO valves against (surgical valve replacement) SAVR in over 1,400 patients.
Medtronic noted that the low-risk patient population is the final surgical risk category to be approved for the minimally invasive alternative to open-heart SAVR.
The system is currently indicated in Europe for severe aortic stenosis patients across all risk categories.
Evolut low-risk trial investigator Thomas Modine said: “The low-risk indication marks an important milestone for patients across Europe as TAVI expands into a potentially younger and more active patient population.”
The Evolut TAVI platform also received an expanded indication for treating patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.
Bicuspid aortic valves are a congenital heart defect, affecting 1%-2% of the general population. It is an abnormality of the aortic valve, which causes two functional valve leaflets instead of the more common three leaflets (tricuspid) in patients.
Medtronic Cardiac and Vascular Group Structural Heart and Cardiac Surgery businesses vice-president and chief medical officer Pieter Kappetein said: “With these approvals, more patients will now be candidates for the Evolut TAVI system, while surgical aortic valve replacement will evolve to serve a more complex patient population.
“Medtronic is well-positioned to provide a variety of therapy options to meet the varying needs of patients with heart valve disease.”