Cardiac Rhythm Management Market Faces Continued Challenges Ahead

Article preview from Medtech Insight - August , 2011

The CRM market is facing continued growth challenges as manufacturers struggle to jumpstart lagging sales and broaden adoption of implantable cardioverter defibrillators and cardiac resynchronization therapy devices while facing a brewing storm in the US over appropriate device use.

Cardiac Rhythm Management Market Faces Continued Challenges Ahead

Article preview from Medtech Insight - August , 2011

The cardiac rhythm management (CRM) market, which includes implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy devices (CRTs), and conventional cardiac pacemakers, is facing continued growth challenges as manufacturers struggle to jump-start lagging CRM sales and broaden adoption of ICDs and CRTs while facing a brewing storm in the US over appropriate device use.

At this year's Heart Rhythm Society (HRS) meeting, held in San Francisco in May, device manufacturers showcased their latest technological advances in the CRM arena while physicians debated the appropriate use issue.

JAMA Study Raises Questions

The latter came to the forefront in January, when researchers, led by Sana M. Al-Khatib, MD, of Duke University School of Medicine and the Duke Clinical Research Institute, published a study in the Journal of the American Medical Association suggesting that a substantial percentage of US physicians may not be following evidence-based guidelines for ICD implantation. Findings from this widely publicized study, along with an ongoing US Department of Justice (DOJ) investigation to determine if providers improperly billed Medicare for nonqualified ICD implants, have electrophysiologists (EPs) and others in the CRM community on the defensive.

The JAMA study authors based their analysis on implant data entered into the National Cardiovascular Data Registry-ICD Registry (NCDR-ICD), a database mandated in 2005 by the Centers for Medicare and Medicaid Services (CMS) in order to capture information on ICD implants performed in Medicare patients. Nearly 1,500 hospitals currently participate in the registry and close to 80% are entering data on all of their ICD implants, including those performed in non-Medicare patients.

Continued...

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