St. Jude Medical has enrolled the first patients in a European post-approval observational study of its Nanostim leadless pacemaker, the St. Paul, Minn.-based devicemaker said Tuesday. Nanostim received the CE mark last year, though the device remains investigational in the U.S.
The prospective, multicenter, postmarket LEADLESS study will enroll approximately 1,000 patients at about 100 European centers. The company expects the study to provide long-term data about the device’s safety and performance with ventricular single-chamber pacing.
St. Jude hopes the results will “further demonstrate how the Nanostim improves patient outcomes and implant procedure efficiency,” said company spokesman Mark Carlson.
Nanostim differs from traditional pacemakers in that it is implanted in the heart using a noninvasive catheter through the femoral vein. The device — one-tenth the size of a traditional pacemaker — eliminates the visible surgical pocket, scarring and leads that can cause discomfort and complications in people with other models.
The company launched the LEADLESS II pivotal trial to support an application for FDA approval last month. It is expected to enroll 670 patients at 50 U.S. sites. — Lena Freund
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