SAM #36C24426Q0759

Procurement of Leksell Vantage MRI-Compatible Stereotactic Frame Components for DBS Procedures

The Corporal Michael J. Crescenz VA Medical Center, under the Department of Veterans Affairs and Network Contracting Office 4, is procuring MRI-compatible stereotactic frame and navigation system components to support Deep Brain Stimulation (DBS) procedures. - Buyer: Department of Veterans Affairs, Network Contracting Office 4, Corporal Michael J. Crescenz VA Medical Center - OEM Highlight: Leksell Vantage system (manufactured by Elekta AB) - Products requested: - 10 distinct Leksell Vantage system components, each with a quantity of 1 - LEKSELL VANTAGE KEY (part number: 1040051) - LEKSELL VANTAGE CROSS-HAIRS (1040025) - LEKSELL VANTAGE HEAD FRAME (1040036) - LEKSELL VANTAGE ARC SYSTEM (1040048) - LEKSELL VANRAGE ARC TRAY (1040045) - VANTAGE STARBURST 3/8" (1040093) - LEKSELL VANRAGE FRAME HOLDER (1040114) - EN/LEKSELL VANRAGE/QRG (1556500) - EN/LVSS ARC SYSTEM/QRG (1569126) - EN-US/LEKSELL VANTAGE SYSTEM/IFU (1572849) - All items must be MRI-compatible and serve as backup units to ensure redundancy and uninterrupted surgical operations - Products must be delivered in original sealed containers and inspected by Biomedical Engineering upon receipt - Delivery required within 90 days of contract award, during normal business hours - Compatibility with existing Leksell stereotactic system is mandatory

Description

Note: Any reference to a brand name product herein is provided solely for descriptive purposes and shall not be construed as an intention by the Department of Veterans Affairs to procure that specific product. This is a reference for size, form, and function, to be compatible with existing systems, and line items for configuration to ensure the system meets all the proper technical requirements required by the medical center. Overall the purpose is to enhance competition and not restrict it.

STATEMENT OF NEED INTRODUCTION: The Corporal Michael J. Crescenz VA Medical Center requires a MRI-compatible stereotactic frame and navigation system specifically to enhance the capabilities for performing Deep Brain Stimulation (DBS) procedures at our facility.

BACKGROUND: Deep Brain Stimulation (DBS) is a recognized treatment for various neurological conditions, including Parkinson s disease, essential tremor, and dystonia. The procedure involves implanting electrodes within certain areas of the brain to produce electrical impulses that regulate abnormal impulses or affect certain cells and chemicals within the brain.

CMC VAMC currently uses the Leksell stereotactic system for precise navigation and targeting during these intricate procedures. While the existing system provides a solid foundation, certain components must always have back-ups to maintain the highest standards of care, improve outcome accuracy, and expand the procedural capabilities in line with modern advancements in DBS.

The procurement and integration of these additional back-up components will have a profound impact on our service- delivery.

OBJECTIVES: The primary objective of this procurement is to procure additional components necessary to have more than one item on hand for the existing Leksell system. All procedures should have more than one of each item which ensures that the surgical procedures can proceed without interruption in case of equipment failure or reprocessing issues. This is critical to maintain patient safety and integrity. Sterilization and cleaning after each use is time-consuming. Having multiple units allows for continuous operations while ensuring that clean and sterile equipment is always ready.

Providing the OR with more than one of the necessary pieces of equipment is a vital practice to ensure preparedness, reliability and efficiency in delivering high-quality surgical care. It addresses the needs for redundancy, specialized requirements, and educational purposes while enhancing patient safety and overall operational effectiveness. Reducing the risk of equipment related delays or failures directly impacts patient safety and quality of care. Ensuring that there are backup units and enough equipment to handle just one case is paramount for maintaining high standards. DELIVERY: Delivery days are Monday through Friday during normal business hours which are defined at 7:30am to 3:00pm. National Holidays are excluded. Any delivery service performed for emergency orders may be delivered other than normal- business working hours and must be approved ahead of scheduled delivery. The Contractor is not required to provide delivery services on the following National Holidays, nor shall the Contractor be paid for these Holidays and any other declared national holiday by the President.

HOLIDAY MONTH New Year s Day January Martin Luther King s Birthday January President s Day February Memorial Day May Juneteenth June Independence Day July Labor Day September Columbus Day October Veterans Day November Thanksgiving Day November Christmas Day December

Contractor shall deliver all equipment to the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104 Delivery must be completed within 90 days of award of contract Deliver materials to job manufacturers original sealed containers with brand name marked thereon or maintain coverings in place and in good repair. PO# mut be clearly marked on the outside of the shipping box for easy identification by the warehouse staff.

INSPECTION: The warehouse shall receive all equipment prior to Biomedical Engineering inspecting the equipment. Disputes shall be resolved by the Contracting Officer.

Additional Links:Philadelphia VA Medical Center

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