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In the News
Innovation Pays Off At Edwards Lifesciences
Investor’s Business Daily published an article on June 10, 2011 following an interview with Edwards' Chairman and CEO, Michael A. Mussallem. The article focuses on products such as the SAPIEN transcatheter heart valve and GlucoClear glucose in-hospital monitoring system as evidence of the company’s innovations that support its growth. | |  | | | | | Edwards’ Statement on Medical Device Article in the Chicago Tribune
The Chicago Tribune published a story and sidebar on May 22 and a second story on May 23 about medical device approvals that is misleading, especially for the many patients whose lives have been improved by mitral valve repair using annuloplasty rings, or are patients who should be treated by this therapy.
As the global market leader in both heart valve replacement and repair, Edwards maintains the highest quality standards for our products. The technique of mitral valve repair was developed more than 30 years ago to address the unique complexities of mitral valve disease. The majority of these patients are relatively young and benefit from a procedure that preserves and repairs their native valve, rather than replaces it with a prosthetic valve. The published literature supports mitral valve repair as a very safe procedure, and in fact, medical guidelines from the American College of Cardiology/American Heart Association recommend repair for specific patients suffering from mitral valve disease (Bonow et al, JACC, Aug. 1, 2006): “MV repair is recommended over MV replacement in the majority of patients with severe chronic MR [mitral regurgitation] who require surgery, and patients should be referred to surgical centers experienced in MV repair.” The procedure is also supported by numerous peer-reviewed publications, including data demonstrating 20-year durability (Braunberger et al, Circulation, Sept. 18, 2001). The diseased valve is somewhat different in each patient. Annuloplasty rings provide a specific shape to enhance durability and reproducibility of this specialized procedure, requiring surgeon skill and judgment.
The U.S. Food & Drug Administration (FDA) has a rigorous, science-driven process for reviewing new medical technologies that Edwards Lifesciences respects and follows closely. The Chicago Tribune article claimed that the 5100 annuloplasty ring did not have appropriate regulatory clearance. Edwards has been on the record multiple times on this topic, and FDA has stated we “made a good faith effort” and an “honest attempt” to follow its guidance when Edwards used FDA’s Justification to File (JTF) process in 2006 to introduce its 5100 ring. Occasionally, the FDA reviews a manufacturer’s decision and disagrees, and this is what took place with the 5100 ring. Additional FDA review was conducted, the FDA cleared the ring, and the rings being sold today are identical to the products sold earlier under the JTF authorization, except for the name.
Patient safety always has been, and always will be, our top priority. Using this as our guide, during the last several years, we have taken a rigorous and conservative approach to reporting events for the FDA’s MAUDE database, which may be reflected in the increased number of reports for our company. For the vast majority of these reports, investigation by Edwards Lifesciences found no relationship between the injury or death and the device. Furthermore, the FDA itself says MAUDE data cannot be relied upon for an analysis of injuries and deaths, stating on the front page of the Web site, “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices” (emphasis added). Reports in MAUDE may be based on duplicate or limited information, and include circumstances, as stated above, where the cause of injury or death was completely unrelated to the medical device or was related to the surgical procedure/recovery (independent of the implant). The Chicago Tribune’s use of the information in this database to analyze adverse event reports was based on its speculation of the details of these reports.
It is always unfortunate when patients are needlessly scared by unfounded reports. Providing life-saving treatments to patients has always been our primary focus, and we will continue to partner with clinicians to develop innovative technologies that help enhance and save patients’ lives.
New Heart Valve Trial
Edwards' Chairman and CEO, Michael A. Mussallem, appears on CNBC’s “Squawk on the Street” on April 4, 2011 talking about the results of a clinical trial regarding the company’s transcatheter heart valve. | | video
 | | | | | Money in Medical Devices
Edwards' Chairman and CEO, Michael A. Mussallem, appears on CNBC’s “Squawk on the Street” on January 11, 2011 talking about the company’s transcatheter heart valve. | | video
 | | | | | News Archive
Pivotal Year
In an article published on January 2, 2011, Edwards' Chairman and CEO, Michael A. Mussallem, was named 2010 Businessperson of the Year by the Orange County Business Journal. | |  | | | | | Promise of New Valve Driving Edwards
The Orange County Business Journal published an article on May 16, 2010 following an interview with Edwards' Chairman and CEO, Michael A. Mussallem. The article highlights Edwards' transcatheter heart valves and the company's lead as it enters the U.S. market with approval expected in 2011. | | | | | | | Keep the Heart of Innovation Pumping
On May 23, 2010, the Orange County Register published an article regarding health care reform and the tax that will be imposed on medical device manufacturers. This opinion piece is the result of an interview (video on the right) with Edwards' Chairman and CEO, Michael A. Mussallem, which was published on May 19, 2010. | | video
 | | | | | Recent Trends in Hemodynamic Monitoring
Edwards Lifesciences was featured in the February 2010 issue of Medtech Insight in an article about the latest trends in hemodynamic monitoring. The article focuses heavily on Edwards' advancements in critical care technologies, including the company's FloTrac and continual glucose monitoring systems. | |  | | | | | |
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