“This system includes unique features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity.”
In short
Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark in Europe for its EDWARDS INTUITY Valve System for use in patients undergoing surgical aortic valve replacement (AVR). The system, which consists of a bovine pericardial heart valve and novel delivery system, facilitates small incision surgery and rapid valve deployment during AVR procedures. The company plans to begin a disciplined European launch at centers participating in post-approval clinical studies.
Background
The EDWARDS INTUITY Valve System leverages the design of Edwards’ pericardial valve technology, which is based on the company’s nearly 30-year leadership in tissue valve design. The valve features an innovative balloon-expandable frame designed to facilitate rapid and secure annular placement intended to reduce overall procedural time. The novel delivery system is designed to enable control, accuracy and simplicity throughout implantation.
Clinician comments
“Minimally invasive therapies are increasingly being sought by patients because of their demonstrated benefits, and the EDWARDS INTUITY Valve System allows us to provide small incision aortic valve replacement with a proven valve platform,” said Prof. Michael Borger, M.D., Ph.D., associate director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany and investigator in the TRITON study, which evaluated the feasibility, safety and performance of the EDWARDS INTUITY Valve System. “This system includes unique features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity.”
Company comments
“This system was developed with key insights and learnings from leading surgeons, and demonstrates our commitment to continued innovation in surgical heart valve therapy,” said Donald E. Bobo, Jr., Edwards’ corporate vice president, heart valve therapy. “We are excited about the promise of this technology to advance the current standard of care for clinicians and their patients.”
Not yet FDA cleared
The EDWARDS INTUITY Valve System is not yet available for sale or use in the United States.
Source: Edwards Lifesciences
published: February 16, 2012 in: Approval/Clearance, Cardio, Regulatory