Physicians at St. Bartholomew’s Hospital in London placed the Nanostim pacemaker into a 77-year-old female patient to treat atrial fibrillation. The device is designed to be implanted in a less-invasive procedure via the femoral vein without the leads that accompany a traditional pacemaker, the company says. At less than one-tenth the size of a normal pacemaker, the inch-and-a-half-long tube fits inside the heart and contains a battery designed to last about 9 years.
Minnesota’s St. Jude bought privately funded Nanostim in October last year for $123.5 million, after helping the company develop the technology and navigate the regulatory approval process. Before the purchase, Nanostim had already secured a CE mark for the device, eventually giving St. Jude a leg up on rivals Medtronic ($MDT) and Boston Scientific ($BSX), which are both trying to get their own leadless pacemakers on the market.
No wireless version is approved in the U.S., but the FDA recently granted an investigational device exemption, which St. Jude said could allow the launch of a pivotal trial.
The arrival of the wireless pacemaker is expected to jump-start sales in that part of the market, which have become stagnant due in part to complications like infection and lead failure, associated with standard pacemakers.
For St. Jude, the acquisition of Nanostim marked one effort to turn the company around after sales sagged more than a year ago. In that time, the company has shown solid growth as it reported last week net sales for the year of $5.5 billion and an 8% jump in net earnings.
“The first postapproval implant in the U.K. is an important step for this revolutionary technology platform and a proud addition to St. Jude Medical’s strong history in pacing innovation,” Paul Turner, St. Jude’s U.K. vice president, said in a statement. “By providing a smaller, leadless pacing technology, physicians will now be able to offer patients a device that upholds the accuracy of conventional pacemaker technology via a minimally invasive procedure.”