Refined Focus, Continued Advances 4409

COVER STORY

In recent years, Edwards Lifesciences Corp. (Irvine, CA) has divested a number of product lines as a means of freeing up resources and turning its focus toward further development of its heart valves and critical-care businesses.

"Our market-leading heart valve and critical-care franchises provide a strong foundation for continued growth," said Michael A. Mussallem, Edwards's chairman and CEO. "We expect our strategic portfolio changes and sales of new products to drive greater profitability and grow earnings. Additionally, our market-expanding transcatheter valve technologies are expected to generate more than $20 million of sales this year."

Some of the company's latest advances in these divisions include the following.

Edwards Sapien Transcatheter Heart Valve. In September 2007, Edwards received CE mark approval for European commercial sales of its Edwards Sapien transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system. The Sapien transcatheter heart valve, which is currently the subject of a landmark clinical trial in the United States, is implanted via a minimally invasive procedure on a beating heart, without requiring open-heart surgery. The valve is designed to treat patients with severe aortic heart valve stenosis—a narrowing of the valve that restricts blood flow—who are considered to be high risk or nonoperable for conventional open-heart valve replacement surgery.

In December 2007, the company received CE mark approval for the Edwards Sapien transcatheter heart valve with the Ascendra transapical delivery system—in which the valve is inserted between the ribs—providing a second valve-delivery option for surgeons.

PediaSat Oximetry Catheter. In August 2007, Edwards introduced the first real-time, continuous central venous oxygenation saturation monitoring technology for critically ill children. The PediaSat oximetry catheter uses fiber optics to monitor and identify potentially life-threatening changes in oxygen saturation of venous blood in critically ill children. According to the company, this technology—previously available only for adults—is even more important for children because they typically do not exhibit the same warning signs of potentially fatal issues and can destabilize much faster than adults.

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