Edwards Lifesciences has become so well known in the past decade for its leadership in transcatheter valves, that it's sometimes easy for industry watchdogs to overlook the fact that Edwards also continues to innovate in the surgical valve space.
"Edwards has a strategy around structural heart, and for us, that means both transcatheter and surgical," said Daveen Chopra, corporate vice president of Edwards' surgical structural heart business. "We want to treat these heart diseases and valve issues whatever way needs to be done for the best possible outcome for the patient."
Chopra told MD+DI that the overall pool of patients needing a new heart valve continues to grow, in part because the transcatheter valve market has increased awareness of structural heart disease. And while transcatheter valves are a great solution for many patients, there will always be patients who need to have a surgical valve replacement.
"So we're still very focused on surgery, even as transcatheter keeps growing like crazy," Chopra said.
And Edwards backs up this point with clinical data. For example, the company recently announced COMMENCE study results showing that Edwards' bioprosthetic surgical aortic valves featuring its novel Resilia tissue platform continued to demonstrate favorable safety and hemodynamic performance through a median of four years follow up, with no events of structural valve deterioration (SVD). The study enrolled 694 patients and 144 of them (21%) were under the age of 60 when they had surgical valve replacement. The data were presented this month at the American Association for Thoracic Surgery's annual meeting.
It was important to enroll a significant number of younger patients in the COMMENCE study, Chopra said, because the Resilia tissue is designed to last longer than previous generations of valve tissue technology.
"Patients undergoing valve replacement are living long lives and remaining more active through their later years, increasing the need for advanced valve replacement technologies," said John Puskas, MD, principal investigator for the COMMENCE study. "The absence of structural valve deterioration in these patients is extremely encouraging and highlights the potential of valves containing Resilia tissue for patients who may otherwise opt for a mechanical valve, which requires long-term use of blood thinning medications."
Edwards' Resilia bovine pericardial tissue incorporates a novel integrity-preservation technology that may eliminate a key factor in calcification leading to valve deterioration. The technology also allows the valve to be stored under dry packaging conditions, facilitating ease of use in the operating room.
"Our gradients in this study remain constant over the four years, always in this 10 mm Hg to 11 mm Hg range, which means the valves aren't slowly starting to deteriorate," Chopra said. "Usually in studies, gradients start going up the further out you get, so we were really excited to see those two points (no SVD and low gradients).
The COMMENCE trial is a prospective, non-randomized multicenter, single-arm investigational device exemption trial at 27 sites across the United States and Europe. The study is designed to evaluate the safety and effectiveness of surgical aortic heart valves with Resilia tissue in this patient population for up to five years, with a subset of patients being evaluated through 10 years.
"The Resilia tissue platform was created with a vision to extend valve durability for a more active patient population, while reducing the need for long-term use of blood-thinning medication," Chopra said. "These encouraging COMMENCE trial data suggest that we are on the path toward realizing that vision."
Additional five-year data from a European feasibility study of a bioprosthetic aortic valve with RESILIA tissue were presented last month at the Heart Valve Society's annual meeting. This study, a prospective, single-arm observational clinical trial of 133 patients conducted at two clinical sites in Europe, also yielded positive results. There were no events of SVD throughout the study period, Edwards noted.
The company also plans to further evaluate the new tissue platform through the RESILIENCE trial, a longer-term study that will follow 250 patients under the age of 65. That study will examine calcification levels, hemodynamic deterioration, and valve failure at years five, seven, nine and 11 as early potential predictors of valve durability.