Edwards Lifesciences has reported positive interim data from a European prospective study of its investigational EDWARDS INTUITY valve system.
According to the company, surgeons at five centers achieved a technical success rate of 94 percent. A total of 90 patients with severe, symptomatic aortic stenosis or stenosis-insufficiency received the EDWARDS INTUITY valve system in an isolated aortic valve replacement or AVR with a concomitant procedure. For the isolated AVR procedures, mean aortic cross-clamp times were reduced by 43 percent, and mean bypass times by 41 percent, compared to the STS National Database.
"We are encouraged by these interim results and the promise of this new technology. Implantation using the EDWARDS INTUITY Valve System may enable smaller incisions for isolated valve cases, which we believe could result in clinically significant benefits for patients," said Axel Haverich, head of the Department of Cardiothoracic Transplantation and Vascular Surgery at Hannover Medical School in Germany and lead investigator of the study, in a release. "At three months' follow-up, these patients demonstrated sustained clinical status improvement and the valve provided excellent hemodynamic performance."
The data are from the TRITON clinical study, evaluating the feasibility, safety and performance of the valve system, which is based on Edwards' pericardial tissue valve design. These data are intended to support the company's CE Mark application for European commercial approval. The valve system is an investigational device limited and is not yet available commercially in any country.
- see the Edwards release
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