Ireland-based medical technology firm Medtronic has received CE mark approval for the new 26mm and 29mm sizes of the CoreValve Evolut R System.
CoreValve Evolut is a self-expanding valve that improves performance and deliverability during transcatheter aortic valve implantation (TAVI). It also provides the option to recapture and reposition the valve during procedures.
The new valve sizes are delivered through a 14 French equivalent delivery system, which provide an extended sealing skirt that will promote valve sealing at the annulus.
Medtronic heart valve therapies vice-president and general manager Rhonda Robb said: "Expanding patient access to the CoreValve Evolut R System has been a high priority, and we know the additional valve sizes have been highly anticipated by the physician community since the launch of the 23mm valve last fall.
"Over the next several months we will support heart teams through training and education, imaging and patient evaluation programs that exemplify our safe and deliberate approach to expanding patient access."
According to the company, the system includes CoreValve Evolut R transcatheter aortic valve and CoreValve EnVeo R Delivery Catheter System, and provides a new InLine Sheath to treat patients with smaller vessels (less than 5.0mm), which is said to minimize the risk of major vascular complications in patients.
The new sizes of the CoreValve Evolut, along with EnVeo R Delivery Catheter System, are available in Europe and other countries that recognize the CE mark, and it is not approved for commercial use in the US, where it is currently undergoing clinical trials, noted Medtronic.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.