The Dublin, Ireland-based medical devices manufacturer Medtronic plc. Ordinary Shares (NYSE:MDT) has revealed that the Food and Drug Administration has approved the Avalus surgical valve that is used as a treatment for aortic valve disease. In the European Union the avalus valve also received the CE Mark.
Some of the new features of Avalus are intended to improve clinical performance as well as to meet the current needs of cardiac specialists besides patients who require aortic valve replacement. Commercial availability of the Avalus valve will start later in the year.
“Medtronic is committed to advancing its surgical portfolio to offer cardiac surgeons a contemporary option to help meet the individual needs of this patient population,” stated Rhonda Robb, the general manager and vice president of Heart Valve Therapies, a division of Medtronic.
According to cardiac surgeon Robert Klautz both patients and physicians were involved in designing the Avalus valve. Klautz who teaches at Holland’s Leiden University Medical Center also observed that as a result, the valve has improved in durability and it will also be easier to implant.
Some of the significant developments in the Avalus valve include a frame design and an interior-mounted leaflet all of which serve in enhancing durability. Hemodynamic performance has also been improved through a supra-annular design and this will limit central regurgitation. To make implantation easier the valve design is low profile and the valve holder has been streamlined.
American Association of Thoracic Surgery
Before the approval was granted by the Food and Drug Administration a trial involving over 1,100 patients in around 40 clinical sites spread across North America and Europe was conducted. Results of the study were presented by UH Cleveland Medical Center’s Joseph Sabik at the annual meeting of the American Association of Thoracic Surgery which was held in Boston, Massachusetts. After one year, the results revealed that there was improved hemodynamic performance, high survival rates and low rates of adverse events. The participants of the study will be followed for a period of up to 60 months.
On Wednesday shares of Medtronic plc. Ordinary Shares fell by 0.38% to close the day at $83.20.