Edwards Lifesciences has announced positive clinical trial results on two of its advanced innovations in surgical heart valves for the treatment of people with aortic valve disease. Data from three studies—COMMENCE, TRANSFORM and FOUNDATION—were presented as part of the late-breaking sessions at the American Association for Thoracic Surgery’s (AATS) 96th annual meeting.
“Edwards is proud to lead the innovation of heart valve therapies to address a broad range of patient needs around the world, and these compelling new data on more than 2,000 patients provide important clinical evidence on the benefits of new surgical treatments,” says Bernard Zovighian, Edwards’ corporate vice president, surgical heart valve therapy. “We are committed to expanding our surgical heart valve portfolio with meaningful innovations and by continuing to work in partnership with surgeons to meet the needs of patients who suffer from a variety of heart valve diseases.”
COMMENCE Trial Data
Data from 673 patients in the COMMENCE pivotal trial demonstrated early safety and effectiveness of Edwards’ surgical aortic valve featuring RESILIA tissue, a novel tissue platform. Beyond delivering strong safety results, the new valve with RESILIA tissue showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction at one year.
“The early clinical results with the new valve with RESILIA tissue in this multicenter, international FDA trial are encouraging and set a high benchmark for surgical aortic valve replacement,” said John D Puskas, chair of cardiothoracic surgery at Mount Sinai Beth Israel and director of surgical coronary revascularization at Mount Sinai Health System, New York, USA. He is the national principal investigator of the COMMENCE study. “The RESILIA tissue has the potential to create a new class of surgical tissue valves that pre-clinical studies have shown to offer key benefits, such as significantly reduced calcification and sustained haemodynamics.”
TRANSFORM and FOUNDATION Trial Data
Also at AATS, the TRANSFORM pivotal trial data at one year showed that the EDWARDS INTUITY valve system, a cutting-edge rapid deployment system for surgical aortic valve replacement, is safe and effective and may reduce cross-clamp time and cardiopulmonary bypass time, compared to times recorded in the Society of Thoracic Surgeons’ (STS) Adult Cardiac Database. This may provide patient benefits such as decreased mortality and morbidity, less time in an intensive care unit and reduced total hospital stay. In the study, 839 patients were treated with this device, which is built on the trusted PERIMOUNT tissue valve platform incorporating innovations from transcatheter heart valves. It evaluated both the first-generation EDWARDS INTUITY valve (n=109) and the second-generation EDWARDS INTUITY Elite valve (n=730).
In addition, the FOUNDATION registry studied the real-world experience of 493 patients who were treated with the first-generation EDWARDS INTUITY valve system in Europe, with results demonstrating excellent safety and effectiveness at one year.
“There is a clinical need for innovative surgical heart valve therapies to ensure patients receive the appropriate treatment, and the EDWARDS INTUITY Elite valve system is designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements, which is a major advancement,” said Walter Randolph Chitwood, Jr, founder of the East Carolina Heart Institute of East Carolina University, Greenville, USA. He is a co-principal investigator of the TRANSFORM study.
Valves with the investigational RESILIA tissue are being studied as part of the COMMENCE trial, a global clinical programme with three study groups: aortic, mitral and pulmonary. Data presented at AATS reported on the aortic arm of the program. The mitral study is enrolling patients, and the pulmonary study for congenital patients, including children and young adults, began enrollment in late 2015.
The second generation Edwards INTUITY Elite valve system was approved for commercial sale in Europe in 2014; it is not available for sale in the United States.