St. Jude Medical (NYSE:STJ) tried to distance its Durata defibrillator leads from their troubled Riata predecessor and unveiled the results of the decade-long SCD-HeFT heart failure study during separate presentations at this year’s Heart Rhythm Society meeting in Boston, Mass.
In a special, highly attended talk entitled "Should we trust Durata?" Dr. Chuck Love told listeners that "Durata is 85% different from Riata," according to TheHeart.org.
"It is a very, very different lead," Love told the audience, noting that Durata’s Optim coating is more robust that the recalled Riata’s silicone insulation.
Wells Fargo analyst Larry Beigelson wrote in a note to investors that the presentation was "positive" overall, but not everyone was convinced. Some left the presentation asking for comparative bench tests to allow doctors to see for themselves the difference between the leads.
An independent study released yesterday found, contrary to St. Jude’s reports, that survival rates with one of the company’s the Riata’s survival rates were “significantly worse” than those of rival Medtronic’s (NYSE:MDT) Quattro leads.
In a separate session, St. Jude unveiled follow-up results spanning more than a decade of observation on patients with implantable cardiac defibrillators.
The 10-year ICD study, sponsored by St. Jude; the National Heart, Lung, & Blood Institute; and the National Institutes of Health, concluded that the therapy "significantly reduces mortality for at least 11 years in patients with moderate heart failure," according to a press release.
The study included more than 2,500 patients in comparing ICD therapy with a placebo or a drug regimen, finding that long-term mortality at 12 years was 5% lower for patients randomized to receive a "conservatively programmed shock-only ICD" than for patients in the placebo group, despite a significant number of the control patients receiving devices after the end of the original trial.
"While the original findings of the SCD-HeFT trial advanced the standard of care for patients with heart failure, the follow-up data are critical to define long-term ICD mortality benefits," Dr. Jeanne Poole, professor of medicine at the University of Washington, told an audience at an HRS late-breaking clinical trial session. "The SCD-HeFT findings demonstrate that patients experience the lifesaving benefit of ICD therapy over a decade of clinical heart failure."
The original SCD-HeFT study followed patients for an average of about 5 years and was instrument to changing national reimbursement policy for ICDs, according to a press release.
Medtronic study shows delay in ICD therapy can reduce unneeded shocks
Medtronic (NYSE:MDT) unveiled results from what it calls the 1st and only clinical trial of both primary and secondary patients to demonstrate that its implantable cardiac defibrillators and cardiac resynchronization therapy with defibrillation devices can delay therapy, spending more time detecting abnormal rhythms before delivering a shock, without increased risk to patients.* Read more
MRIs pose low risk to heart device patients, interim report shows
An interim study from the MagnaSafe registry suggested that patients with pacemakers and ICDs who underwent received MRIs were generally unaffected by the procedure, with the exception of occasional alternations in programming, battery-voltage changes and other events that researchers deemed clinically insignificant. Read more
Updated May 11, 2012: The Medtronic study was the first to include both primary and secondary patients; previous studies had been established for primary patients.
