Heart Rhythm Society Issues Recommendations on CRM Devices

Late last month a 15-member task force assembled by the Heart Rhythm Society (HRS; Washington, DC) issued its long-awaited recommendations on cardiac rhythm management (CRM) devices. The recommendations included specific suggestions for physicians, manufacturers, FDA, and Congress. The group called for greater transparency in postmarket surveillance, analysis, and reporting of device problems; the establishment of new systems to more quickly identify malfunctioning devices; and the development of standard notification and communication procedures for CRM manufacturers to follow when a malfunction is identified.

The report also recommended that FDA no longer use the term recall in public communications about potentially malfunctioning CRM devices, as patients could interpret the word as meaning the device should be removed. HRS suggested substituting the phrase advisory notice or safety alert.

“This report offers the first comprehensive recommendations for the surveillance, analysis, and performance reporting of pacemakers and implantable cardioverter-defibrillators (ICDs),” said HRS president Dwight Reynolds, MD. “These changes will help patients continue to have confidence and trust in these lifesaving treatments.”

“The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients, and other stakeholders to ensure that these recommendations will guide key policy decisions that will help heart patients,” said task force chair Mark D. Carlson, MD.

The recommendations follow a year-long process that began with a joint meeting of HRS and FDA in September 2005. The meeting was sparked by the highly publicized recall of nearly 200,000 ICDs and cardiac pacemakers manufactured by Guidant Corp. (Indianapolis), which was acquired by Boston Scientific Corp. (Natick, MA) this past April.

The HRS report urged CRM device manufacturers to develop and implement wireless and remote monitoring technologies to identify abnormal device behavior as early as possible, and to reduce underreporting of device malfunctions by determining the functioning status of an implanted device more frequently and more accurately.

Leading CRM device manufacturers Boston Scientific, Medtronic Inc. (Minneapolis), and St. Jude Medical Inc. (St. Paul, MN) have issued statements in support of the HRS recommendations.

In a prepared release, Boston Scientific said the company “continues to support and commend the Heart Rhythm Society for the development of guidelines regarding device performance. We continue to believe these guidelines are in the best interest of patients and physicians, and we plan to adopt them.”

Steve Mahle, president of Medtronic's CRM business unit, said, “We commend the Heart Rhythm Society for its leadership in defining these issues and for its efforts in bringing forth solutions.”

Michael J. Coyle, president of the CRM division at St. Jude Medical Inc. (St. Paul, MN), said, “We recognize the important role that communications can play in helping our stakeholders understand that ICDs and pacemakers save thousands of lives and are safer and more reliable than ever. St. Jude Medical was an active participant with the HRS task force in the development of these final guidelines and strongly supports the principles outlined by HRS.”

Both Medtronic and St. Jude Medical said that many of the HRS recommendations have been part of their standard practices for years.

Earlier this month, St. Jude Medical—which now lays claim to the number two position in the U.S. CRM market—appointed HRS task force chair Carlson as its chief medical officer and senior vice president of clinical affairs for its CRM division.

According to market research firm Frost & Sullivan (Palo Alto, CA), the U.S cardiac rhythm management market posted 2005 revenues of $5.99 billion and is projected to reach $16.79 billion by 2012.

The recommendations of the HRS task force are available via the society's Web site at www.hrsonline.org/swPositionStatementFiles/ps149532272.asp.

© 2006 Canon Communications LLC

Return to MX: Issues Update.