CUSA® Clarity Ultrasonic Tissue Ablation System for Perioperative Medicine

Amendment 0001

The purpose of this amendment is to:

1. Correct the entity name of the intended source from Buffalo Supply Inc. to Integra LifeSciences Corp. Princeton, NJ 08540.

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to Integra LifeSciences Inc. Princeton, NJ 08540 to procure the CUSA® Clarity Ultrasonic Tissue Ablation System. The CUSA® Clarity, will support all Neurosurgeons when performing Craniotomy surgery involving glioma and more specifically tumor resection where preservation of passing vessels for achieving better resection is key.   This instrument will be used by the Department of Perioperative Medicine (DPM) which is dedicated solely to supporting clinical and surgical research. DPM is currently comprised of 11 OR suites, a 15 bed PACU and Pre-Op unit for inpatient and outpatients. The CUSA® Clarity allows for better tissue handling for intraparenchymal brain lesions as well as for integration with the Stealth S8 System.  Integration is key and allows for a better surgical outcome. 

Integra LifeSciences is the registered trademark holder and exclusive equipment manufacturer of the CUSA® Clarity and Buffalo Supply Inc. is the sole distributor of the CUSA® Clarity only through the government purchasing vehicle ECAT. The CUSA® Clarity is the only system on the market that can offer the following features:

 • Tough Tissue Tips: Fast and Safe for De-bulking-through fibrous tissue without sharp cutting edges and thorough waves of ultrasonic energy

• Precision and Power Handpieces-Handpiece uses high-frequency vibration to localize effect and reducing collateral damage and has a thermal diffusor

• Secure Suction-maintains continuous tissue-tip contact for efficient debulking enabled through strong aspiration

• Adaptive Power-Adjusts power for tough tissue and offers additional control around critical structures

• Consistent FragmentationStorz technology has been utilized in DPM since 2004 and has provided the best option for the needs of the Surgeons serving the clinical center patients.

This acquisition is being conducted using policies unique to FAR Part 13.5 Test Program for Certain Commercial Items and specifically FAR 13.501(a) Special Documentation Requirements, Sole source (including brand name) acquisitions where acquisitions conducted under Simplified Acquisition procedures are exempt from the requirements of FAR 6, but still require a justification using the format of FAR 6.303-2.

 Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.