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This notice of intent is not a request for competitive proposals. However, all proposals received prior to the closing date of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Deliveries should be sent via email or package Delivery Services. NO COLLECT CALLS OR FACSIMILE TRANSMISSIONS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL TO THE POINT OF CONTACT LISTED IN THIS NOTICE INTENT SYNOPSIS
This procurement is for Vitaldyne products for use in Clinical Study:Feasibility of Inducing Intra-arterial Thrombosis for Vessel Occlusion via Radiofrequency-Enhanced Embolization . Radiology & Imaging Sciences intends to procure custom designed scientific equipement and supplies to be used in a Clinical Study. A purchase order for supplies will be processed for the required products.
1.0 INTRODUCTION/OVERVIEW
The Center for Interventional Oncology requires the procurement of electrically conductive catheters, and conductive basket devices in the ongoing research to prevent infections caused by indwelling intravenous catheter.
1.1 BACKGROUND
Patients who are chronically ill, undergoing long term treatments with intravenous medications require placement of catheters into large main blood vessels. Despite scrupulous care, these catheters often become infected and patients require re-hospitalization, more medications and sometimes a new indwelling catheter must be placed. The morbidity and cost associated with "line infections" is enormous. The cost of to the patient is unmeasurable. The fiscal cost of the estimated 15 million catheter related infections exceeds 300billion a year.
The Center for Interventional Oncology major research initiative is to perform preclinical research trials in proof of concept protocols of "electrically conductive vascular access devices and catheters" to determine if they will inhibit bacterial attachment and subsequent systemic infection.
1.2 SCOPE
The Center for Interventional Oncology expects to complete research related to catheter caused system infections that will be shared to the medical community in peer reviewed journal, at conferences and be the basis for clinical trials.
1.3 OBJECTIVES
Goal: Trial conductive catheters and conductive baskets to prevent indwelling catheter infections
Objectives: Procure for preclinical trials, #20 Conductive catheters and baskets
Result: Preclinical trials
2.0 REQUIREMENTS
2.1 TASKS
Specification/performance
• The contractor should have experience designing and fabricating custom vascular interventional medical devices (conductive catheters and conductive baskets) to the exact specifications of the Center for Interventional Oncology.
• The incumbent will be uniquely skilled in maintaining the electrical and signal integrity of materials.
• The contractor should have the material science and electrical and mechanical engineering expertise to create custom molds that enable catheter assembly.
• The contractor should also have the skill and expertise, to create these devices with biocompatible materials and epoxies that are also sterilize-able.
2.2 DELIVERABLES
• #20- Conductive catheters Less than 10 amps, 16 cm in length, battery source custom fabricated electrodes embedded in the polymer of the catheter in order to conduct electricity via the catheter.
• #20 NITINOL basket formed legs and delivery wire conductive basket devices
2.3 SCHEDULE
Performance will be at the contractor's facility. Request manufacturing upon receipt of PO, as these are likely to be custom made, receipt expectations are up to 6 months after PO is received. Upon delivery the products will meet expectation up until 1 year of receipt.
This procurement is to be processed using Simplified Acquisition Procedures-Commercial Item Acquisition in conjunction with FAR Part 12 Commercial Item Acquisition of Commercial Items. The NAICS code/Size is 339112/500 employees. There is no solicitation package available. For any questions regarding this announcement, please contact Contract Specialist Gail Akinbinu at the National Institutes of Health, Clinical Center, Office of Purchasing and Contracts,10 Center Drive , Room 1C541, Bethesda, MD 20892, or via email to [email protected].