St.Jude’s Nanostim Leadless Pacemaker European Post-Approval Study Starts

St. Jude Medical, Inc. has started enrolling patients in its LEADLESS Pacemaker Observational Study evaluating the Nanostim™ leadless pacing technology. The study is designed to build additional evidence to support the safety profile of the device in patients indicated for ventricular single chamber pacing.

Background

Nanostim is designed to be implanted directly into the heart via a non-surgical procedure. The device is designed to be placed without the visible surgical pocket, scar and leads required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device is designed to be fully retrievable so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology on the market today. It received CE Mark approval in 2013, since when implants have occurred in the UK, Germany, Italy, Czech Republic, France, Spain, and the Netherlands.

The LEADLESS Pacemaker Observational Study is a prospective, multi-center, post-market clinical  It will provide long-term data about the Nanostim leadless pacemaker and will provide additional information about the long-term performance of the device. St. Jude says the trial is the largest to study leadless pacemakers, and will enroll approximately 1,000 patients in approximately 100 centers in Europe.

Investigator comments

“This large, European study was uniquely designed to help assess the health benefits associated with the Nanostim leadless pacemaker,” said Dr. Johannes Sperzel, principal investigator (PI) in the study and head of the electrophysiology department at the Kerckhoff Klinik in Bad Nauheim, Germany. “We look forward to adding to the already strong clinical evidence supporting the benefits to patients receiving this revolutionary technology.”

Company comments

“Nanostim pacemaker technology is one example of St. Jude Medical’s commitment to helping physicians improve health outcomes across the globe,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Our European clinical trial aims to further demonstrate how the Nanostim pacemaker improves patient outcomes and implant procedure efficiency through its minimally-invasive design. We are delighted to see this groundbreaking technology enable physicians to improve the lives of patients worldwide.”

Source: St. Jude Medical, Inc., Business Wire

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