St Jude Medical has announced the first US implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim leadless pacemaker for US Food and Drug Administration (FDA) approval.
Dr Vivek Reddy of Mount Sinai Hospital in New York City implanted Nanostim leadless pacemaker, the world’s first retrievable, non-surgical pacemaker, representing an important milestone in bringing transformational pacing technology to the US patients.
The LEADLESS II pivotal study, a prospective, non-randomised, multi-centre, international clinical research trial is designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device.
It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centres in the US, Canada and Europe.
Unlike conventional pacemakers that require a more invasive surgery, the Nanostim leadless pacemaker is the first miniaturised device that removes the need for leads, offering decreased invasive and less complicated procedures for physicians and patients.
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 the device can be readily repositioned during the implant procedure and later retrieved if necessary such as at the time of normal battery replacement.
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 the exclusion of a lead, improves patient comfort and can reduce complications, including device pocket-related infection and lead failure.
According to the company, eliminating 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 by allowing most to continue living active, uninhibited lifestyles.
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 vice-president of global clinical affairs Dr Mark D Carlson said: "Despite this evolution, pacing technology has, until now, required surgery in addition to leads that connect the pacemaker to the heart."
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.
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 CE Marked Nanostim leadless pacemaker is now available in select European markets but is not available for sale in the US.
Image: Nanostim leadless pacemaker. Photo: courtesy of Business Wire / St Jude Medical, Inc.