FDAnews Device Daily Bulletin

INDUSTRY RESPONDS TO HEART RHYTHM SOCIETY RECOMMENDATIONS ON HEART DEVICES

April 28, 2006
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Initial industry responses to recommendations by the Heart Rhythm Society (HRS) addressing heart-device performance issues have been positive.

"We commend the Heart Rhythm Society for its important work in drafting recommendations to improve current reporting practices on pacemakers and implantable cardioverter-defibrillators (ICDs)," said Stephen Mahle, president of Medtronic's cardiac rhythm disease management division. Mahle noted that most of the HRS recommendations have been standard practice at his company for a number of years.

"Boston Scientific plans to implement all the recommendations that apply to manufacturers," said Jim Tobin, president and CEO of Boston Scientific. "In particular, we believe an industry-wide, independent committee of outside experts should be established." He cited Guidant for having already implemented many of the items in the HRS proposal. Boston Scientific completed its acquisition of Guidant Corporation on April 21 (for related story, see May 1 issue of Devices & Diagnostics Letter (http://www.fdanews.com/wbi/newsletters/device.html)).