Updated on 15 October 2013
The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker. Photo courtesy: Business Wire
Singapore: US-based St Jude Medical, a global medical device company, has announced the completion of its acquisition of Nanostim, a privately-owned developer of miniaturized, leadless pacemakers, for $123.5 million up front and potentially $65 million more in the future.
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 commercialization initiatives.
Unlike conventional pacemakers that require a more invasive surgery, 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 insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems.
The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received US Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the US.
"The Nanostim leadless pacemaker represents one of the most important advances in the history of pacing technology, and builds on St Jude Medical's strong history of pacing innovation - beginning with the first implantable pacemaker in 1958 through the introduction of quadripolar cardiac resynchronization therapy pacing," said Mr Eric S Fain, president of the St Jude Medical Implantable Electronic Systems Division. "We look forward to welcoming Nanostim employees to St Jude Medical and to continuing our legacy of transforming the treatment of cardiac rhythm disorders with pioneering technology," Mr Fain added.