CMS' decision to limit prophylactic ICD coverage to patients with a QRS duration of over 0.12 seconds will increase demand for cardiac resynchronization therapy (CRT) ICDs at the expense of conventional implantable defibrillators, St. Jude Medical maintains.

"Our expectation is that we are going to continue to see robust growth for the overall ICD [market] in the 30%-35% range, but that there will be slightly more CRT in those numbers than we had been thinking a quarter ago," St. Jude VP-Cardiac Rhythm Management Mike Coyle explained during a July 16 earnings call.

The agency's decision to cover ICDs for the MADIT-II population - heart attack patients with a low ejection fraction - was expected to be a boon to the ICD industry, since it was projected to cover upwards of 400,000 U.S. patients annually.

However, CMS restricted its June coverage decision to MADIT-II patients with a QRS duration of longer than 0.12 seconds - about one-third of the original MADIT-II patients (¹ Also see "CMS To Meet With NASPE/HRS, Manufacturers To Review ICD Decision Process" - Medtech Insight, 16 June, 2003., p. 9). Although considered a rough surrogate marker for cardiac desynchrony, QRS duration also is used to identify candidates for CRT ICDs ("² Also see "ECG Desynchrony Tests Hold Key To CHF Prevention With CRT – Researchers" - Medtech Insight, 7 April, 2003., 2003, p. 6).

"Going forward, we think that the fact that the 120 millisecond limitation on the MADIT-II has been added is going to skew it more toward CRT than we had originally expected to see," Coyle predicted. As a result of the CMS decision, St. Jude, which does not yet sell a CRT device, cut its ICD revenue estimate for 2003 to $410-$425 mil. from $425-440 mil.

While St. Jude ICD sales were up 42% to $106 mil. for the second quarter, growth was below some analysts' expectations. The firm noted, however, that its share of the worldwide non-CRT ICD market has grown by three percentage points to 17% since Guidant and Medtronic released their CRT devices last summer. St. Jude credits the progress to the its Epic Plus ICD with proprietary atrial fibrillation suppression technology, approved in April.

St. Jude remains on track to submit a PMA application for its CRT device, the Epic HF ICD, in the fourth quarter, according to the company (³ Also see "St. Jude Adds QuickSite Lead, “V-to-V” Pacing To RHYTHM Epic HF Trial" - Medtech Insight, 28 April, 2003., p. 21).

St. Jude Claims 3-Point ICD Market Share Gain Since CRT Competition Began

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