6515--CORI Robotic Surgical System Brand name or Equal to

DEPARTMENT OF VETERAN AFFAIRS

STATEMENT OF NEED

Smith and Nephew CORI Surgical Robot and Software

Introduction: The Pittsburgh VA Medical Center (646) located at University Drive C., Pittsburgh, PA 15240, has a new brand name or equal to, requirement for two (2) Smith and Nephew CORI Surgical Robot System, and Instruments.

Background and Scope of Work: We are requesting brand name or equal purchase of the Smith and Nephew CORI Surgical Robot System, and Instruments for the Operating Room at VA Pittsburgh Healthcare System (VAPHS). This system is upgraded technology to complement conventional procedures by robotic-assisted computer-aided technology.

The CORI System is an image-agnostic registration and real-time gap assessment designed to help optimize alignment and balancing. A more efficient system that features an ergonomic handpiece with burr designs delivering twice the cutting volume (29% faster resection). The Advanced Tracking System offers a 458% faster refresh rate, and enhanced workflow requires fewer steps saving time in the Operating Room. This system is designed to be portable with a small OR footprint, using Real Intelligence software to offer broad capabilities and an expanding range of joint reconstruction indications.

Any equal to surgical robot for knee and hip, must be compatible with FDA approved implants, and be technically acceptable in size, form, and function.

Total and partial knee surgery:

Designed to achieve accuracy in bone resection and alignment.

Revision knee surgery:

The first system indicated for robotic-assisted revision knee surgery in the US.

Image-free smart mapping eliminates potential for image distortion caused by in-situ components, with 3D joint models registering anatomy and bony defects after implant extraction.

Total hip surgery (software only):

RI.HIP Navigation allows surgeons to assess pelvic tilt, providing a predicted view of the post-operative anteroposterior (AP) X-ray in surgery and digital measurement of leg length/offset changes.

Pittsburgh s Surgical Services currently has four (4) Orthopedic Surgeons that will be using the CORI Robot for total knee, and total hip procedures. An additional two (2) Orthopedic Surgeons will be joining Pittsburgh s Surgical Services, and plan on training/using the CORI Robot. The CORI Surgical System was agreed upon by the current surgeons for standardization of one platform for compatibility with the Smith & Nephew implants used in Pittsburgh. This robotic-assisted system has better results in lower revision rates, patient discharge times, improved implant positioning, reduced blood loss, and total surgical time than conventional UKA (Unicompartmental Knee Arthroplasty) and TKA (Total Knee Arthroplasty).

Characteristics of the CORI Surgical System:

CORI is the only system on the market that offers true integration of robotics into a hand-held solution.

CORI is FDA-cleared for an image-free workflow; this means it is not dependent on any pre-operative image. The image is acquired intra-operatively by utilizing smart mapping technology to be quick, simple, and highly accurate.

The CORI System is indicated for every Smith & Nephew knee implant, which Pittsburgh s Surgical Service stock.

The CORI Planning Software is simple and can be utilized by either a touch screen or tablet, therefore no outside support is required to operate the system.

CORI is the size of a light box that typically sits on a surgical endoscopy/video tower. CORI s small footprint allows for a very simple and easy room-to-room transition.

CORI is equipped with Atracsys camera that has 458% faster refresh rate than the NDI camera (current industry standard for medical robots). This allows for the lowest latency rate on the market and increases accuracy and efficiency.

Service and Software Subscription:

Smith & Nephew s Service and Subscriptions are included for the first twelve (12) months with the purchase of equipment.

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.