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HRS 2010: Subcutaneous ICD Generates Excitement, Controversy

Executive Summary

In the years since the dawn of the ICD era in the 1980s, perhaps four expansions of the implantable cardioverter defibrillator have captured the imagination of electrophysiologists and signaled unqualified success for the major manufacturers of these life-saving devices. Now, a new generation of ICD--the S-ICD or totally subcutaneous ICD--has the potential to join those sophisticated devices as the next truly evolutionary development in the field. Interest in the S-ICD picked up steam this spring in Denver at the 31st annual scientific sessions of the Heart Rhythm Society, where researchers presented the latest clinical results with the device.

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Brief summaries of recent medtech market and industry developments. This month we cover results from the EVEREST II trial on the MitraClip percutaneous mitral valve repair system, CareFusion's acquisition of Medegen, Sanofi and Agamatrix's glucose monitoring deal and Myriad Genetics' unfavorable patent ruling.

Boston Scientific Recalls All Implantable Defibrillators, Suspends Sales

Boston Scientific is recalling all lines of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators nationwide because the firm made manufacturing process changes without proper FDA approval

Sensing the State of the CRM Market

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. Those products drove annual growth rates above 20%. But in 2005, this growth came to a screeching halt due to product recalls and other safety issues. To address these concerns, CRM manufacturers are working with the FDA and the Heart Rhythm Society to restore the trust of both implanting physicians and the patient community.


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