Basic SOW Rosa Robot 2026_redact Posting ver.doc

SOW Zimmer Biomet Rosa Robot 1.

Introduction and Overview

The Neuro Surgeons requested a Rosa Robot in 2021. It was received in July of 2021. It is now time to procure a preventative maintenance agreement for the Rosa. The initial primary indication for robotic assistance was for the placement of intracranial depth electrodes that are routinely used to localized seizure activity in patients with drug resistant epilepsy. Neurosurgical robots can provide highly accurate stereotactic localization of target structures for placement of these electrodes. This experience first started in Europe, but by 2019, the majority of academic institutions specializing in the surgical treatment of epilepsy have now adopted robotic assistance for placement of these electrodes. Since that initial experience, the indication for the use of a robot has expanded to other procedures that require accurate localization in the human brain. These include stereotactic biopsies for diagnostic purposes, endoscopic intra-ventricular approaches for lesions that are present in the lateral or third ventricle, placement of intracranial deep brain stimulation electrodes, and endoscopic trans-sphenoidal approaches for tumors present in the seller region. It is imperative that a preventative maintenance agreement is in place to prevent the Rosa from breaking down during surgery.

1.1 Background

The Surgical Neurology Branch provides standard and novel treatments for patients with neurosurgical disorders at the NIH Clinical Center. To remain current with cutting edge treatments that have emerged as the standard of care, it would be important to have available at the Clinical Center a neurosurgical robot that can improve and facilitate treatment of patients with neurosurgical disorders. The ROSA neurosurgical robot manufactured by Zimmer Biomet is the leading and most commonly used neurosurgical robot across medical centers in the United States. Robotic assistance of neurosurgical procedures has become standard care across the majority of academic medical centers around the United States. The ROSA neurosurgical robot has been developed to assist with surgical navigation and localization for a variety of indications.

1.2

Scope of Work

NIH Operating Room is requesting the purchase of the PMA for the Rosa Robot, so neurosurgery can continue to provide Clinical Center patients with image-guided surgery that is the standard-of-care in modern neurosurgery. The Surgical Neurology Branch has expanded the number of procedures offered annually for patients with drug resistant epilepsy over the past several years. In addition, the Branch continues to offer routine surgical care for patients with brain tumors and other lesions of the central nervous system. Robotic assistance for accurate navigation and localization can additionally be used for many other indications, including those that are not specific to neurosurgery, such as surgical procedures performed in the head and neck by ENT. This request also includes 12 cases of support in the Operating Room for surgical cases.

1.3 Objectives

The proposed vendor, Zimmer Biomet is the only manufacturer/supplier worldwide to offer this latest advance in navigational technologies that can perform the preventative maintenance on their equipment, making them the Sole Source. No other reasonable alternative source exists that meets the agency requirements because the ROSA neurosurgical robot is recognized as the leader in the neurosurgical robot field, being the most commonly used robot for neurosurgery cases and having more studies documenting its accuracy and patient safety record than robots from other manufacturers.