SPECIAL NOTICE
66 -- VAMC Providence -Pressure Volume Loop System
- Notice Date
- 9/1/2021 10:20:25 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24121C0064
- Archive Date
- 10/01/2021
- Point of Contact
- Deborah L Reardon, deborah.reardon@va.gov, Phone: 410-691-1140
- E-Mail Address
-
deborah.reardon@va.gov
(deborah.reardon@va.gov)
- Awardee
- null
- Description
- SOW Pressure Volume Loop System Statement of Work Veterans Health Affairs, Network Contracting Office 1, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide INCA Pressure-Volume Loop System to measure cardiac volumes as described below and will not interrupt the continuum of care. This requirement is defined by an existing unit currently in use at the Providence VAMC. ALL RESPONSES TO THIS INTENT TO SOLE SOURCE ARE DUE 9/8/2021 2:00 PM EST 1. Title of Project: Pressure Volume Loop System for Cardiology PVAMC 2. Scope of Work: We are requesting the purchase of the Pressure Volume Loop System for our Cardiology and Structural Heart Program. 3. Background: The Pressure Volume Loop System is designed to optimize management of complex and high-risk patients; to help determine the aggressiveness of therapy with afterload reduction and/or diuretic therapy. The Pressure Volume Loop System analyses a single pressure volume loop generated by plotting pressure and volume signals against each other in real time, with one loop representing a complete cardiac cycle. Pressure volume loop analysis system is FDA approved technology which consists of a console, the Inca, with a computer that includes the software for analysis of the patient s information. The hardware of the device includes a disposable pressure-volume ( conductance ) catheter that will be placed in the left ventricle. This catheter, when connected to the computer can provide multiple detailed and accurate information of the baseline characteristics of the patient s condition, such as the stroke volume, cardiac output, stroke work, bioenergetics of the ventricle, systolic and diastolic function of the ventricle, etc. The information obtained by this catheter can be tremendously helpful for the clinician as to what the next steps of the treatment options would be to improve the clinical outcomes of the patients. The pressure-volume loop analysis system would fit seamlessly into our workflow and help to optimize management of complex and high-risk patients. While there are many applications to the use of this device, several areas that would be immediately helpful are in the assessment of paravalvular aortic regurgitation and post-deployment stroke volume. These are important characteristics since they are both associated with poor long-term outcomes. Lastly, some patients continue to have heart failure symptoms after a successful TAVR procedure. In such patients, understanding the compliance and elastance of the ventricle has significantly improved by using the Inca catheter. This information can help to determine the aggressiveness of therapy with afterload reduction and/or diuretic therapy. 4. Data/Deliverables: Product Number Product Description Quantity 4100079 7Fr Disposable PV Loop Catheter with 0.025 lumen and 12 electrodes, with 10mm electrode spacing 10 3001880 Integrated, standalone system for the acquisition, display and analysis of clinical intra-ventricular pressure and volume loops. Includes the INCA hardware, a touchscreen medical PC and the ConductNT analysis software 1 4100189 Pro Cart for complete INCA system 1 9900012 Three (3) consecutive days of Clinical Applications Specialist (CAS) onsite installation & training/in-service + 20 hours of focused CAS remote support time (additional training, system/case support, data review, troubleshooting. Etc.) 1 5. Scheduling and Hours of Work: Deliver all items specified under item #4 Data/Deliverables to Jordan Anderson CE. Preferred Delivery Date: August 27, 2021 (or sooner) 6. Staff Education: Three (3) consecutive days of Clinical Applications Specialist (CAS) onsite installation & training/in-service + 20 hours of focused CAS remote support time (additional training, system/case support, data review, troubleshooting. Etc.) This training will be scheduled by section manager. 7. Evaluation/Selection Factor: 1. Technical Capability: units must meet all technical requirements listed in SOW/Salient Characteristics list 2. Past Performance: clinical support, customer service/responsiveness, reliability
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c86d264ef8ab4a50b4989232756551c5/view)
- Record
- SN06119007-F 20210903/210901230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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