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.

The Sapien valve integrates balloon-expandable stent technology that leverages Edwards's proprietary Perimount bovine pericardial tissue. With the RetroFlex transfemoral delivery system, the valve is compressed onto the balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg, and expanded into place directly over the diseased aortic valve.

Edwards has achieved more than 500 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the United States, and Canada. 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 since they typically do not exhibit the same warning signs of potentially fatal issues and can destabilize much faster than adults.

Prior to the PediaSat catheter's introduction, clinicians had to rely on manual, intermittent blood sampling to monitor a child's oxygenation status in a critical-care setting. Intermittent blood sampling does not provide the same level of information as the PediaSat oximetry catheter, and incurs the risks of multiple blood draws, infection, and increased potential for transfusions.

FloTrac System. In mid 2007, Edwards launched its FloTrac sensor in Japan. The FloTrac sensor, which is also commercially available in the United States and Europe, provides certain key continuous cardiac measurements by accessing data directly from an arterial line, a small catheter inserted into the patient's radial artery. Because most hospitalized critically ill or surgical patients already have an arterial line in place to measure basic cardiovascular information and to draw blood, the FloTrac sensor is particularly easy to use, Edwards reports.

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