Article preview from Medtech Insight - June 2008
After years of steady single-digit growth, the cardiac rhythm management market was jump-started this decade by the expansion of implantable cardioverter defibrillators and the development of cardiac resynchronization therapy devices. Find out what's driving this new growth.
Sensing the State of the CRM Market
Article preview from Medtech Insight - June 2008
If a chart of the past decade of sales growth in the cardiac rhythm management (CRM) market was read as an ECG, the physician would be rightfully concerned about the patient's pattern of recent peaks and troughs. After years of steady, unspectacular single-digit growth in the 1990s, the CRM market was jump-started in the new decade largely by the expansion of implantable cardioverter defibrillators (ICDs) to the primary prevention (mostly post-heart attack) patient population and the development of cardiac resynchronization therapy (CRT) devices.
These developments drove annual growth rates above 20%, making CRM among the fastest growing segments of the device industry. But in 2005, this growth came to a screeching halt due to safety concerns triggered by the high-profile recall of thousands of ICDs manufactured by Guidant Corp. (now part of Boston Scientific Corp.). Since then, a series of subsequent recalls and advisories impacting both Boston Scientific and market leader Medtronic Inc. have kept the safety issue alive and well, the latest a Class I recall issued last October involving Medtronic's ICD leads.
The multiple safety issues that have cast a safety pall over the CRM industry are largely responsible for sales declining to low-single digit growth rates, and that has forced manufacturers to focus on improving the industry's safety profile in order to re-invigorate sales. To address these concerns, CRM manufacturers, working with the Food and Drug Administration (FDA) and the Heart Rhythm Society (HRS), adopted new guidelines designed to increase post-market transparency to unprecedented levels. This strategy of overhauling safety protocols is intended to restore the trust of implanting physicians (and has also impacted transparency in other device markets as well), and the patient community as a whole. (See "The Future of Cardiac Rhythm Management," Medtech Insight, August 2006.)
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Companies mentioned in this article:
Biotronik GMBH & Co.
Boston Scientific Corp.
CryoCor Inc.
Guidant Corp.
Cleveland Clinic
EP MedSystems Inc.
Medtronic Inc.
Sorin Group SPA
St. Jude Medical Inc.
Surgi-Vision Inc.
University of California
University of California, Los Angeles
University of Heidelberg
University of South Florida
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