The Nanostim leadless pacemaker acquired by St. Jude Medical (NYSE:STJ) last year appeared safe and functional after 3 months, according to results of a small study published in the American Heart Assn. journal Circulation.
The study of 33 patients in Prague and Amsterdam met its primary safety endpoint (freedom from complications at 90 days) in 94% of patients. The Nanostim device, which is smaller than a triple-A battery, was implanted successfully in 32, or 97%, of patients, according to the study. Five patients, or 15%, needed more than 1 of the Nanostim devices during their implantation procedures, the authors wrote.
"One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as a result of stroke," according to the Nanostim-sponsored study. "After 3 months of follow-up, the measures of pacing performance (sensing, impedance and pacing threshold) either improved or were stably within the accepted range."
In addition to the feasibility study, which is no longer enrolling patients, St. Jude is running an investigational device exemption trial in the U.S. involving 667 subjects and a 1,000-patient European post-approval study.
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