Medical device firm St. Jude Medical has revealed the primary results of the Leadless II study, which demonstrated the positive benefits of the Nanostim leadless pacemaker in patients requiring single-chamber ventricular pacemaker.
According to the firm, the study also showed the longer-term retrievability and significant projected battery longevity of the Nanostim.
In October 2013, the company obtained CE mark approval for the Nanostim leadless pacemaker, which has been developed to be implanted minimally invasively through the femoral vein.
Nanostim is implanted with the with the smallest available leadless technology delivery system that includes the delivery system catheter and an 18 F introducer.
New York’s The Mount Sinai Hospital electrophysiology director and study’s principal investigator Dr Vivek Reddy said: "The Leadless II study results are advancing our understanding of leadless pacing technology and highlighting a number of benefits for physicians seeking a minimally invasive, leadless option for patients in need of permanent, single chamber pacing therapy."
The company has enrolled 526 patients at 56 centers in the trial across the US, Canada and Australia.
The trial reached both endpoints for primary effectiveness, including appropriate pacing and sensing, as well as safety
Leadless II study also showed that retrieval of the implanted Nanostim leadless pacemaker was successful in maximum number of patients requiring retrieval without any associated complications and the longevity is estimated to be 9.8 years at 100% pacing.
St. Jude Medical chief medical officer Dr Mark Carlson said: "The Nanostim leadless pacemaker allows for a procedure without the need for a surgical pocket or the leads required by traditional pacemakers."
Image: Nanostim leadless pacemaker. Photo: courtesy of St. Jude Medical, Inc.