Executive Summary
The Nanostim Leadless Pacemaker System is a medical device designed to provide pacing therapy for patients with bradycardia.
The system consists of a leadless pacemaker, a delivery catheter, a programmer, and a retrieval catheter system.
Overview of the Nanostim Leadless Pacemaker
The device is intended to be implanted in the right ventricle and can be retrieved if necessary.
The system has undergone a pivotal study to evaluate its safety and effectiveness.
The study results are presented in this manual, including the primary effectiveness and safety endpoints.
A post-approval study and training program are also proposed to further evaluate the device’s performance and to educate physicians on its use.
Manual:
Download: St. Jude Medical Nanostim Leadless Pacemaker System User Manual
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