A leadless pacemaker, approved for use in Europe, has found its way into its first U.S. patient, St. Jude Medical announced Thursday. Dr. Vivek Reddy implanted the Nanostim leadless pacemaker at The Mount Sinai Hospital in New York, starting a pivotal trial for FDA approval.
 |
| St. Jude's Nanostim leadless pacemaker--Courtesy of St. Jude Medical |
When St. Jude ($STJ) bought Nanostim from its namesake company, last October, the tiny device already had a CE mark. News of the U.S. trial commencement follows a little over a week after St. Jude announced the first Nanostim implantation in a U.K. patient--a 77-year-old woman with atrial fibrillation. Ultimately, the U.S. trial aims to enroll about 670 patients at 50 locations in the U.S., Canada and Europe.
As a nonsurgical device, Nanostim is designed to be implanted directly inside the heart via the femoral vein using a steerable catheter, for a less-invasive approach than the typical surgery required to implant a pacemaker. It's about one-tenth the size of cardiac pacemakers on the market today, with a battery expected to last 9 to 13 years, the company says.
Initial results with Nanostim were presented last year, showing device performance comparable with existing pacemakers. Implant procedure times averaged 28 minutes, the company said.
"This new-age, tiny pacemaker may ultimately be safer for patients because it doesn't have leads or have to be inserted under the skin of a patient's chest, like a traditional cardiac pacemaker," Reddy said in a statement.
Medtronic ($MDT) is also working on bringing a wireless pacemaker to market.
- read the St. Jude release
Editor's Corner: The pacemaker inside me: What I learned about the industry as a cardiac patient