St Jude Medical announces acquisition of Nanostim and CE mark of first leadless pacemaker


On 14 October, St Jude Medical announced the completion of its acquisition of Nanostim, a privately-owned developer of miniaturised, leadless pacemakers. The Nanostim leadless pacemaker, which recently received the CE mark approval, is less than 10% the size of a conventional pacemaker and it is designed to be implanted directly into the heart via a minimally invasive procedure avoiding the need of surgical pockets and leads.

The acquisition adds the world’s first and only leadless pacemaker to the St Jude Medical product portfolio and culminates a two-year partnership between the two companies during which St Jude Medical invested in and collaborated with Nanostim throughout its product development and commercialisation initiatives.

The Nanostim leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and leads that have historically been recognised as the most vulnerable component of pacing systems. According to a company release, the elimination of the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology.

“For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges,” said Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. “This revolutionary technology offers my patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets. This is the future of cardiac pacing.”

The Nanostim leadless pacemaker was designed to be fully retrievable so that the device can be readily repositioned during the implant procedure and later retrieved if necessary, such as at the time of normal battery replacement. Initial results from the LEADLESS study, a prospective, single-arm, multicentre study evaluating patients with the Nanostim leadless pacemaker,
were presented earlier this year at Heart Rhythm and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes. Even with miniaturisation, the device battery is expected to have an average lifespan of more than nine years at 100% pacing, or more than 13 years at 50% pacing.

Nanostim recently received FDA conditional approval for its investigational device exemption application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the USA.