Cardiac Surgery – Medical Specialties | Medtronic

1

Tadokoro N, Fukushima S, Shimahara Y, et al. Comparison of safety and haemodynamic performance between the Avalus stented aortic valve bioprosthesis and Magna valve in Japanese patients. Gen Thorac Cardiovasc Surg. July 2021;69(7):1060-1069.

The latest results of the Perigon Study, presented by Prof. Dr. Robert J.M. Klautz during EACTS 2021: Surgical Aortic Valve Replacement with a Stented Pericardial Bioprosthesis: 5-year Outcomes. The PERIGON Pivotal Trial regarding the Avalus valve is a prospective, interventional, nonrandomized, worldwide, multi-site trial, with each center following a common protocol. The study was designed in accordance with the recommendations of the EN ISO 5840:2009 standard for cardiac valve prostheses and the U.S. Food and Drug Administration (FDA) Heart Valve Guidance (2010; DRAFT) and conducted in accordance with the Declaration of Helsinki and good clinical practice guidelines. Valve-related events and deaths were adjudicated by an independent clinical events committee (CEC). All study echocardiograms were analyzed by an independent core laboratory (MedStar Health Research Institute, Washington, D.C.). Safety oversight was provided by anindependent data and safety monitoring board (DSMB). This trial is registered at http://www.clinicaltrials.gov, NCT02088554.

Read the original post:
Cardiac Surgery - Medical Specialties | Medtronic