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. The device was implanted at The Mount Sinai Hospital in New York City by Vivek Reddy.
“This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for US patients experiencing heart rhythm issues,” says the study’s co-investigator Vivek Reddy, director of Electrophysiology Services at The Mount Sinai Hospital and chairman of the Steering Committee of the study. “This new-age, tiny pacemaker may ultimately be safer for patients because it does not have leads or have to be inserted under the skin of a patient’s chest, like a traditional cardiac pacemaker. I believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine and may help revolutionise care for patients with arrhythmias. I look forward to the results of the LEADLESS II clinical trial.”
According to a company release, the Nanostim leadless pacemaker is less than 10% the size of a conventional pacemaker and is the least invasive pacing technology available today. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, improves patient comfort and may reduce complications, including device pocket-related infection and lead failure.
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 are routinely put in place in an attempt to prevent dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles.
The device is supported by the St Jude Medical Merlin Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators.
LEADLESS II clinical trial design
The LEADLESS II pivotal trial is a prospective, non-randomised, multicentre, international clinical research trial 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 from the FDA, and will enrol approximately 670 patients at 50 centres in the USA, Canada and Europe.
LEADLESS clinical trial preliminary results
Initial results from the LEADLESS study, a prospective, single-arm, multicentre study evaluating patients with the Nanostim leadless pacemaker, were presented last year 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.
The Nanostim pacemaker received CE mark approval in 2013 and is available in select European markets. The device is not available for sale in the USA.