An Indian-origin doctor performed the first procedure in the United States in which a miniature-sized, leadless cardiac pacemaker was implanted inside a patient's heart without the need for a surgery.
The leads-free pacemaker is implanted by a cardiac electrophysiologist directly inside the heart during a catheter-guided procedure through the groin via the femoral vein.
The device, resembling a small, metal silver tube, is only a few centimeters in length, making it less than ten percent the size of a traditional pacemaker.
The Nanostim device, made by St. Jude Medical, is being tested for safety and efficacy in an international, multicenter clinical trial called LEADLESS II, which is planning to enroll 670 patients at 50 centers across the U.S., Canada, and Europe.
Vivek Reddy, MD, the study's co-investigator who is Director of Electrophysiology Services at The Mount Sinai Hospital and Chairman of the Steering Committee of the study, said that this clinical research trial will be testing the latest innovative, non-surgical pacemaker option for patients experiencing a slowed heart beat.
He said that 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.