FOR IMMEDIATE RELEASE
April 24, 2006
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ADVAMED ANALYSIS SHOWS STRONG, AND IMPROVING, RELIABILITY RATES FOR ICDS
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WASHINGTON, D.C. – Reliability rates for implantable cardioverter-defibrillators (ICDs) have improved significantly from 2001 to 2005, according to an analysis performed by AdvaMed and its ICD member companies.
The analysis, based on data from annual reports ICD manufacturers are required to submit to FDA, show improved reliability rates and that the total malfunction rate fell to approximately one percent in 2005 from 3.1 percent in 2001.
More significantly, the analysis demonstrates that when a well-characterized malfunction which does not compromise patient therapy, known as “long time charge,” is removed from consideration, the malfunction rate drops even further. Long charge time is a known phenomenon associated with the battery technology, primarily in older ICDs, which affects the time it takes to charge the capacitors for therapy delivery.
The AdvaMed analysis builds on a study of ICD and pacemaker malfunction rates from 1990 to 2002 conducted by William H. Maisel, MD, MPH, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and presented in September 2005 at a joint Heart Rhythm Society/FDA meeting in Washington, DC. The Maisel study showed an increase in ICD malfunction rates from 1999 to 2001 before reliability improved and malfunctions dropped in 2002. Both the AdvaMed analysis and the Maisel study relied on the same data source (FDA annual reports) and reported similar data trends for the time (1999-2002) when analysis overlapped.
“These results reflect the medical technology industry’s commitment to patient safety and quality,” said Stephen J. Ubl, President and CEO of AdvaMed. “Manufacturers take aggressive action whenever an issue arises that may affect the performance of their devices. ICDs have a high level of safety and reliability and are responsible for saving hundreds of thousands of lives. Given that only about 20 percent of the 1.6 million Americans who are at risk of death from sudden cardiac arrest actually have an ICD, we need to take steps to promote patient access to these lifesaving devices.”
AdvaMed presented the results of its ICD analysis to officials from FDA’s device center on April 11 and plans to conduct further industry-wide malfunction rate studies in conjunction with its members. The Association will work with both FDA and the Heart Rhythm Society to design the most appropriate and useful malfunction rate studies.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
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