Edwards Lifesciences Corporation announced the U.S. launch of its EMBOL-X intra-aortic embolic management system. The proprietary system, positioned within the aorta, is the only technology currently available in the U.S. that can help surgeons to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during cardiac surgery.

Cardiac surgery has benefited millions of patients worldwide, and continues to save more lives every year. "As cardiac surgery continues to evolve toward more challenging techniques, the EMBOL-X system is the only available solution to address the growing demand of surgeons whose patients need increased protection from potential embolic events," said Dr. Michael Banbury, Staff Surgeon in the Department of Thoracic and Cardiovascular Surgery at The Cleveland Clinic Foundation.

The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers," which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

The EMBOL-X system, part of the recently acquired assets of Embol-X Inc, is the newest addition to Edwards' portfolio of cardiac surgery products. "We are pleased to launch the EMBOL-x system in the U.S. in order to help enhance patient safety during open heart surgery," said Anita B. Bessler, Edwards' corporate vice president, Global Franchise Management. "The unique clinical advantages of the EMBOL-X system complement our portfolio of advanced technologies designed to improve patient outcomes."

The EMBOL-X embolic management system is manufactured at Edwards' facility in Midvale, Utah and is supported by the company's Cardiac Surgery sales force in the U.S. The system is also cleared for commercial sale in Europe and Edwards expects to fully launch the product there in September.