6515--Velys Spine Robot Brand Name or Equal

DEPARTMENT OF VETERAN AFFAIRS

STATEMENT OF NEED

Velys Robotic System (Brand Name or Equal)

Introduction: The Pittsburgh VA Medical Center (646) located at University Drive C., Pittsburgh, PA 15240, has a brand name or equal requirement for one (1) Robotic Spine System, and components.

Background and Scope of Work: The Pittsburgh VAMC (646) is requesting a brand name or equal requirement for one (1) Velys Spine Robot, along with components. The purpose of this Statement of Need is to outline the necessity for the acquisition of the Velys Robotic Spine System to support the expansion of neurosurgery workloads, specifically for spinal navigation surgeries at our facility. The advanced capabilities of this robotic system will enhance the precision and efficiency of spinal surgeries, ultimately improving patient outcomes.

Pittsburgh Surgical Services currently have four (4) Neuro/Spine Surgeons that have agreed upon the Salient Characteristics for a Robotic Surgical System. This additional system will help with the caseload of 2-4 procedures a week.

Salient Characteristics:

Robotic-assisted Surgical System overall must assist the surgeon in the following:

Be able to Identify anatomical structures and placement of spinal implants for spinal fusion procedures.

Help position and orientate surgical instruments.

To be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode.

Spinal Fusion Implant compatibility:

Must be compatible with the existing DePuy Synthes Spine Systems; CROSSNAV , EXPEDIUM VERSE Spine System, VIPER PRIME System, SYMPHONY OCT System, TriALTIS , ANSPACH EG1 High Speed Electric System already in-use at the Pittsburgh VA Healthcare System.

Imaging Requirements:

Must be image agnostic (able to be utilized with any 3D CT or CBCT intraoperative imaging device on the market) such as the GE 3D C-Arm, O-Arm System, Ziehm 3D CArm system, BrainLab Airo, Siemens C-Artic Move, and Siemens Cios Spin arm.

Single-Use Arrays:

The system must have Single-Use arrays that are opened for each spine procedure.

Active-Robotic Assist Station/Hardware:

The system must have the ability to be a modular system; the Navigation system can act independently of the Robotic Assist station.

Must have the ability to manually manipulate the robotic arm in any direction that the surgeon desires.

The Robotic arm must have a handgrip that has infrared LEDs at its proximal and distal ends; these infrared LEDs must create the Robotic arm array which allows the robotic arm to be tracked by the camera.

The arm must have the ability to actively track patient movement based on the patient reference array; and thereby will also maintain alignment to the target.

Must have the ability to when an external force is placed on the robotic arm or tool holder, the robotic arm will maintain its alignment.

The system must have the ability to be a modular system which the Navigation system can act independently of the Robotic Assist station.

The robotic system must have the ability to activate screw release mode; allowing for to ease the removal of the Screwdriver once the inserted screw tip reaches 20% of the length to tip of planned screw length.

Technology/Software:

System software must assist in planning pedicle screws for spinal fusion procedures.

System software must track the positioning of the arrays in real-time.

Must contain graphical user interface (GUI) with touchscreen technology.

Software must contain a feature known as screw release mode - standout innovation, this feature automatically manages the controlled release of the screwdriver once a pedicle screw reaches its target. By sensing positional relationships and adjusting accordingly, it prevents mechanical shudder and workflow interruptions a direct response to challenges in earlier robotic designs.

The system must have a simplified and user-friendly interface that is designed based on click efficiency. Streamlined icons, thoughtful button placement, and a deliberate color scheme.

Ability to toggle between Robotic Assist mode and Freehand Mode throughout the procedure.

The acquisition and integration of the Velys Robotic Spine Robot System is crucial for the neurosurgery department to keep pace with increasing surgical demands and advancements in spinal surgery technology. This investment will enhance our facility s ability to provide high-quality patient care, improve surgical outcomes, and maintain our position at the forefront of medical innovation.

Delivery Requirement: Deliver all line items specified under Data/Deliverables to:

VAMC Pittsburgh ATTN: Warehouse/BioMed

University Drive C. Room 2A118

Pittsburgh, PA 15240

During normal operating hours, M-F 8:00am 3:30pm

Reports/Deliverables:

Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Pittsburgh (646). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. The Contractor will provide training sessions for any relevant surgical and support staff upon request, coordinate installation with facility POC/COR to minimize disruptions and provide timely and

Warranty:

The Contractor will provide a one (1) year warranty covering equipment.

This one (1) year warranty period will commence upon successful installation and validation of the Velys Robotic Spine System.

Security:

The Contractor will come on-site to Pittsburgh VAMC located at University Drive C. Pittsburgh, PA 15240 to provide installation. The Contractor will not have access to any sensitive data.