65--Cardiac resynchronization pacemarker internalcardioverter - defibrillator

The Louis Stokes Cleveland Department of Veterans Affairs Medical Center intends to negotiate a sole source procurement with St. Jude Medical to acquire the V-365 RIATA Optim System and associated leads, which are specifically designed to treat patients with heart failure classified as NYHA Class 3. This procurement is based on the unique Wave Form Tuning feature offered by the device, which the government believes is unmatched by other manufacturers, thereby justifying the sole source approach under FAR 13.106 (b). The notice serves to inform other potential suppliers who may have the capability to meet the requirements that they can express their interest and qualifications by the deadline of 4:00 PM on May 2, 2007. Responses received will be considered solely to assess whether to pursue a competitive procurement, but the decision to proceed with a sole source contract remains at the government’s discretion. No formal solicitation will be issued, and all information provided in response to this notice must be submitted at no cost or obligation to the government. Inquiries concerning this matter must be submitted exclusively by email to the designated Contract Specialist Intern, Jonathan Jewel, with no telephone inquiries accepted. The procurement involves a cardiac resynchronization pacemaker internal cardioverter-defibrillator and falls under NAICS code 334510. The requirement emphasizes the need for a device with distinctive technological features to aid in the treatment of a specific subset of heart failure patients, underscoring the specialized nature of this acquisition.