by
Lauren Dubinsky, Senior Reporter | March 02, 2015
From the March 2015 issue of HealthCare Business News magazine
However, that is only based on a few years of data. The valves usually last between 10 to 20 years, so it will take at least a decade for the question regarding outcomes to be answered. St. Jude Medical’s Nanostim is expected to be the next, hot technology once it receives FDA approval. It is placed directly inside the heart and requires no leads or surgical pocket.
Nanostim is less than a tenth the size of conventional pacemakers and resembles an AAA battery. It consists of a pulse generator that includes a battery and steroid-eluting electrode that transmits pulses to the heart when it detects an issue with the heart’s rhythm.
“There has been a longstanding recognition in our field that the weakest link in a pacemaker has been, for decades, the lead itself,” says Dr. Daniel Cantillon, a cardiologist at Cleveland Clinic. Over four million people worldwide have an implanted pacemaker or other cardiac rhythm management device and more than 700,000 additional patients will receive one every year. Pacemaker complications don’t occur often but when they do, they’re usually caused by the surgical pocket or the leads — about 1 percent of patients have a pocket that becomes infected and about 3 percent have leads that move out of place.
Cleveland Clinic is currently involved in the LEADLESS II trial, required by the FDA, evaluating the effectiveness and safety of Nanostim. The researchers are recruiting appropriate candidates and will have about 670 patients in the U.S. and Canada enrolled. The hospital performed its first implant last February. Cantillon said that traditional pacemakers take him about an hour to implant, but the leadless pacemaker only takes him about 13 minutes.
“[Procedures] that are less invasive and mobilize our patients quicker after surgery are things that benefit both patients and hospital systems,” says Cantillon.
NYP/Weill Cornell Medical Center is also involved in the LEADLESS II trial. Singh said that he believes it’s a fantastic technology when used in the right population — elderly patients and patients with tricuspid valve disease.
For young patients who will require multiple pacemakers throughout their lifetimes, there are still questions regarding how many pacemakers can be put in. For that population, the conventional pacemakers will still be the standard of care.
Duke University Hospital also has experience with Nanostim, but is also involved in a trial investigating Medtronic’s leadless pacemaker called the Micra Transcatheter Pacing System. “We are really enthusiastic about the possibility that it could help reduce the chances of infection from device implantation,” says Dr. Brett D. Atwater, a cardiologist at Duke University Hospital.
