Medtronic Announces CE Mark and European Launch of CoreValve(TM) Evolut(TM) PRO Transcatheter Valve with Advanced Sealing
Monday, July 31, 2017
Source: DMN Newswire
Medtronic plc (NYSE:MDT) today announced CE (Conformité Européenne) mark and European launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve was recently unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, and showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics.
The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.
"The Evolut PRO valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates," said Nicolas M. Van Mieghem, MD, director of interventional cardiology at Erasmus Medical Center in Rotterdam, The Netherlands. "With its ease-of-use and deliverability, the Evolut PRO valve will bring TAVI practice to a higher level, and I look forward to seeing it utilized in patients across Europe."
The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of moderate or severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10 percent.