Mountain View, CA - October 31, 2014 - El Camino Hospital is the first facility in South Bay area to implant the Nanostim™ leadless pacemaker, the world’s first retrievable, non-surgical pacing technology, as part of the LEADLESS II Clinical Trial. Developed for patients with bradycardia – a heart rate that is too slow – the Nanostim device is designed to be placed directly in a patient’s heart without the visible lump, scar and insulated wires (called leads) required for conventional pacemakers.
Dr. Bing Liem and Dr. Fred St. Goar implanted the newest St. Jude Medical device in the first clinical trial patient at El Camino Hospital in late September 2014. The implant took place as part of the LEADLESS II pivotal trial, a prospective, non-randomized, multi-center, international clinical study designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device in the U.S. The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is less invasive than pacing technology available today. The study is expected to enroll approximately 670 patients at 50 centers.
"We are pleased to be involved in this research study to evaluate this potential new technology," said Dr. Liem.
Implanted via the femoral vein with a steerable catheter, the Nanostim leadless pacemaker offers physicians a less-invasive approach compared to traditional pacemaker procedures. The miniaturized device is designed to be fully retrievable so that it can be readily repositioned during the implant procedure and later retrieved if necessary.
"Leadless pacing technology is revolutionary. El Camino Hospital is pleased to be one of the first in the South Bay area to implement this therapy modality" said Tomi Ryba, President & CEO at El Camino Hospital.
Cardiac pacemakers monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.
The Nanostim leadless pacemaker received CE Mark approval in 2013 and is now available in select European markets. The device is not available for sale in the U.S.
For more additional information on Nanostim pacemaker technology, visit sjm.com/leadlesspacing.