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| St. Jude's Nanostim leadless pacemaker--Courtesy of St. Jude Medical |
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.
The Minnesota device company ($STJ) said it will enroll 1,000 patients in 100 centers across Europe. Its LEADLESS Pacemaker Observational study is a multicenter clinical trial designed to gather data about the device's long-term performance and build more evidence to support its use in patients who need ventricular single chamber pacing. Nanostim has had a CE mark since 2013, and surgeons have performed postapproval implants in the U.K., Germany, Italy, Czech Republic, France, Spain and the Netherlands.
And a postmarketing study in Europe will likely help St. Jude Medical generate data for its U.S. approval process. Doctors implanted Nanostim into their first U.S. patient earlier this winter in the launch of a pivotal trial designed to win FDA approval. The U.S. trial will ultimately enroll about 670 patients at 50 sites in the U.S., Canada and Europe.
Nanostim is implanted directly into the heart through the femoral vein using a steerable catheter. It is one-tenth the size of current cardiac pacemakers and has a battery life of 9 to 13 years, according to St. Jude. The company acquired the product last October when it paid $123.5 million-plus for Nanostim's maker, also called Nanostim. The acquisition came two years after St. Jude became an investor with an option to buy the California company.
Hot on St. Jude's heels, Medtronic ($MDT) just began U.S. trials of its own super-small, leadless, Micra transcatheter pacing system. Medtronic bills it as the world's smallest--about the size of a large vitamin. Like St. Jude's Nanostim, Micra is also delivered through a catheter inserted into the femoral vein. It is then attached to the heart wall and can be repositioned or taken out as needed. An electrode at the end of the device delivers electrical impulses to the heart.
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