St. Jude Medical is embarking on a massive postapproval study in Europe for its Nanostim leadless pacemaker, barely weeks after beginning U.S. trials for the same device.
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A leadless pacemaker, approved for use in Europe, has found its way into its first U.S. patient, St. Jude Medical announced Thursday. Dr. Vivek Reddy implanted the Nanostim leadless pacemaker at The Mount Sinai Hospital in New York, starting a pivotal trial for FDA approval.
After buying Nanostim just a few months ago, St. Jude Medical has implanted the company's eponymous leadless pacemaker in a patient in the U.K., a global first for a wireless device of its kind postapproval.
After months of regulatory woes and sluggish sales, St. Jude Medical has spent the past year cutting costs, trimming payroll and digging deep for some high-profile M&A. Now, after stringing together a few positive quarters, the company has won over many analysts and investors, setting the table for a big 2014.
Nanostim says its tiny wireless cardiac pacemaker has shown some success in its first three human patients, early signs that the potentially disruptive technology has legs. And the company's advance, presented this week at the Heart Rhythm Society meeting in Denver, may give it the lead over larger medical device rivals trying to come up with something similar.
Nanostim, a small California startup, says it has successfully implanted a leadless cardiac pacemaker into 11 patients at a hospital in the Czech republic.
Milpitas, CA-based Nanostim has reached an agreement with St. Jude Medical, which has committed to a staged financing of the pacemaker developer, subject to it achieving certain development and