St Jude Medical has announced the first enrolments in its European LEADLESS pacemaker observational study, designed to build additional evidence to support the safety profile of the Nanostim leadless pacemaker in patients indicated for ventricular single chamber pacing.
The European post-approval trial will provide long-term data about the Nanostim leadless pacemaker and will seek to demonstrate additional information about the long-term performance of the device. The trial will enrol approximately 1,000 patients at 100 centres in Europe.
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.
Implanted via the femoral vein with a steerable catheter, the Nanostim leadless pacemaker was designed to be fully retrievable so that it can be readily repositioned during the implanting procedure and later retrieved if necessary during procedures such as standard battery replacements.
The Nanostim leadless pacemaker is less than 10% the size of a conventional pacemaker. Its small size and lack of a surgical pocket, coupled with exclusion of a lead, improves patient comfort and can reduce complications, including device pocket-related infection and lead failure.
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.
The St Jude Medical Merlin Programmer is also used to interrogate and programme the company's other pacemakers and implantable cardioverter defibrillators; it supports the Nanostim leadless pacemaker.
St Jude Medical chief medical officer and global clinical affairs vice-president Dr Mark Carlson said: "We are delighted to see this groundbreaking technology enable physicians to improve the lives of patients worldwide."
St Jude Medical obtained CE Mark for the Nanostim pacemaker in 2013 and post-approval implants have occurred in the UK, Germany, Italy, Czech Republic, France, Spain, and the Netherlands.
Initial results from the LEADLESS study were presented last year and demonstrated overall device performance comparable with conventional pacemakers. Total implant procedure times averaged 28 minutes.
In February, St Jude Medical announced the first US implant in the LEADLESS II pivotal trial, designed to assess the Nanostim leadless pacemaker for US Food and Drug Administration (FDA) approval.
Conducted under an investigational device exemption (IDE) from the FDA, the LEADLESS II pivotal trial will enrol approximately 670 patients at up to 60 centres across the globe with up to 50 sites in the US.
Image: St Jude Medical's Nanostim leadless pacemaker is less than 10% the size of a conventional pacemaker. Photo: courtesy of Business Wire/St Jude Medical, Inc.