The CoreValve Evolut Pro, a device developed by Medtronic plc. Ordinary Shares (NYSE:MDT) to treat patients suffering from severe aortic stenosis and who are too frail to undergo open-heart surgery. Evolut PRO is based on Medtronic’s CoreValve Evolut R System and comes with a valve design that is unique as it possesses an outer wrap which increases the surface area contact and this aids in valve sealing for better performance. Approval of the device follows the release of clinical data during the annual scientific session of the ACC – American College of Cardiology.
The clinical data which was collected from a 30 day trial showed that the device had the effect of reduced leaks, excellent hemodynamics, low stroke rates and high survival rates. With regards to the high survival rate that was observed during the trial, the figure was 98.3%.
Primary endpoint in 30 days
The low stroke rate was evidenced by the fact that it was only experienced in 1.7% of the trial participants. There were absolutely no Paravalvular leaks observed in 72.4% of the trial participants. Also, it was only in 10% of the trial participants that a need for a new pacemaker implant was seen as necessary.
“Based on my experience implanting the Evolut PRO valve during the clinical study, I`ve been impressed by the clinical outcomes achieved in our patients. This innovation represents an important advantage over previous generations of this device…,” Mathew Williams, a cardiac surgeon, said.
Hemodynamic performance
The excellent hemodynamic performance of Evolut PRO was achieved owing to the fact that it was developed with a nitinol frame that is self-expanding. Evolu PRO comes in various sizes including 29, 26 and 23 milimeters.
The delivery of the Evolut PRO is via EnVeo (TM) R Delivery Catheter System with the indication being for vessels of under 5.5 millimeters. To get the devices to the patients who need it the most, Medtronic will be partnering with cardiac surgeons as well as interventional cardiologists. Evolut PRO is, however, not available to patients reside outside the United States.
On Wednesday shares of Metronic Plc edged up by 0.38% to close the day at $81.00.
