First and Only Leadless Pacemaker

St. Jude Medical Inc., a global medical device company, completed its acquisition of Nanostim Inc., a privately owned developer of miniaturized, leadless pacemakers. 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 U.S. 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 U.S.

The Nanostim leadless pacemaker is less than 10% the size of a conventional pacemaker. The small size of the device 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. 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 may prevent the 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 that is also used to interrogate and program the company's other pacemakers and implantable cardioverter defibrillators (ICDs).

"For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges," says Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. "This revolutionary technology offers my patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets. This is the future of cardiac pacing."

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. Initial results from the LEADLESS study, a prospective, single-arm, multicenter study evaluating patients with the Nanostim leadless pacemaker, were presented earlier this year, and demonstrated overall device performance comparable to conventional pacemakers. Total implant procedure times averaged 28 minutes. Even with miniaturization, the device battery is expected to have an average lifespan of more than 9 years at 100% pacing, or more than 13 years at 50 percent pacing.

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than four million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.

This product is not approved for sale in the United States.

Source: St. Jude Medical