SPECIAL NOTICE
65 -- Heart Failure Devices
- Notice Date
- 3/25/2009
- Notice Type
- Special Notice
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of Veterans Affairs, VA National Acquisition Center, Department of Veterans Affairs National Acquisition Center, Department of Veterans Affairs;OA&L / National Acquisition Center;Building 37;1st Avenue, One Block North of Cermak;Hines IL 60141
- ZIP Code
- 60141
- Archive Date
- 5/24/2009
- Point of Contact
- Timothy RichardsContracting Officer<br />
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs is issuing this Request for Information seeking vendors to provide comments on the following draft solicitation. Comments should be addressed to the Department of Veterans Affairs, National Acquisition Center, National Contract Service, Attn: Timothy Richards, Senior Contract Specialist, PO Box 76, Bldg 37 (001AL-A2-3c-PR), 1st Ave, 1 Block North of Cermak, Hines, IL 60141, or by email at timothy.richards@va.gov. Comments are due no later than April 8, 2009, 4:00 pm central time.SECTION B - CONTINUATION OF SF 1449 BLOCKS SCHEDULE OF SUPPLIES The following are the product lines required by this solicitation. A maximum of 3 awards will be made by the Government. Since award is to be made by product line, all items named in Sub-Group A & B must be included in the offeror's product line or the offer will not be evaluated or considered for award and no further consideration will be given to the offer. Also, each offeror is required to offer each manufacturer's complete product lines of all item types listed in Award Group One in order to be considered for award. Note in the Scope of Work Item 4 -- Technology Refresh. Award(s) will be made to the Offeror(s) whose offer best meets the needs of VA patients. (See Evaluation of Offers section) Offerors must supply the below information for the Base Year of the contract. Option year prices will be evaluated using EPA procedures outlined in AS Clause 1515. NOTE: Prices offered must include a cost recovery fee which is currently.50% per Clause AS6001. 19. ITEM NO.20. SCHEDULE OF SUPPLIES/SERVICES 21. ESTIMATED QUANTITY22. UNIT23. UNIT PRICE24. ESTIMATED AMOUNT 1. 1a. 2. 2a. 3. 3a. 3b. 3c. 4. 5. 6.AWARD GROUP ONE Sub Group A CRT-P Cardiac Resynchronization Therapy Device (Pacing only) Model #_____________________ HCPC#____________________ Sub Group B CRT-D Cardiac Resynchronization Therapy Device (with Defibrillation) Model #_____________________ HCPC#___________________ High Voltage Leads (Steroid Eluting, Dual Coil) Dual-Coil integrated bipolar, passive or active fixation. Model#______ HCPC#_____ Dual-Coil "True" Bipolar, passive or active fixation. Model#_____ HCPC#______ Subcutaneous arrays or patches. Model#___ HCPC#_____ Low Voltage steroid-eluting pace-sense leads, passive or active fixation. Model#_____ HCPC#______ Left ventricular (coronary sinus) leads Model#_______ HCPC#_______ Left ventricular (coronary sinus) lead delivery system. Model#_______ HCPC#______ EA EA EA EA EA EA EA EA $________ $________ $________ $________ $________ $________ $_______ $_______ GRAND TOTAL $________ $________ $________ $________ $________ $________ $________ $________ $________ SCOPE OF CONTRACT and STATEMENT OF WORK 1.0 INTRODUCTION Background. The Department of Veterans Affairs (VA) has identified Sub Group A Cardiac Resynchronization Therapy Device with defibrillation (CRT- D), Sub Group B Cardiac Resynchronization Therapy Devices without defibrillation (CRT- P -Pacing only) and related leads as candidate items for consolidated contracting through the Prosthetics Clinical Management Program. The purpose of consolidated contracting is to obtain user uniformity and quality products at lower than current contract and open-market prices. 1.2 Purpose and Objectives. The purpose of this solicitation is to establish supply sources that will provide the contracted items for Prosthetics and Sensory Aids Services at the Department of Veterans Affairs Medical Centers (VAMC). The objectives are to insure availability and consistency of product for nationwide usage and to obtain volume-based, committed use pricing. 1.3 Contract Duration. The base contract period shall be for one year, with four one (1) year options that may be exercised by the Government. 1.4 Contract Effective Date. The effective date of the contract shall be 45 days (or sooner upon mutual agreement) after the date of award. 1.5 Award by Product Line. Award/s will be made by Award Group, not by line item. All relevant items within Award Group One must be included in the offer/s. As detailed in the solicitation each offeror is required to offer their complete product line of all item types in Award Group One. The intended scope of this contract includes all current and future product line items within the award group. The solicitation details the pricing information required to be submitted for these line items. Prices will be established for each of the product line items. VA recognizes that this market is not static and we need to have access to state-of-the-art technology. Therefore, in addition to the items initially contracted for, the scope of this contract includes all items which become available during the course of the contract which are in the award group. New or modified items within the awarded product line may be added to or deleted from the contract at a later date in accordance with paragraph 4.0 Technology Refresh. 1.6 Multiple Awards. This solicitation will result in the Government awarding up to a maximum of three fixed price contracts with economic price adjustments. 2.0 EXTENT OF OBLIGATION 2.1 Government Participants. The contractor shall provide the products specified in the contract directly to VAMCs throughout the United States and Puerto Rico, per the attached list (Attachment __), at the prices awarded herein and under the terms and conditions set forth in the contract upon receipt of a delivery order/purchase order signed by a person with purchasing authority on behalf of a VAMC. Individual VAMCs shall issue delivery/purchase orders to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. 2.2 Estimated Quantities. See Schedule of Supplies for estimates by line item. There is no expressed or implied guarantee that the estimated quantities will be purchased under this contract. The only guarantee is the minimum guarantee elsewhere in this solicitation. Actual quantities may exceed or be less than those represented. The estimates are for the total procurement, not per contract. 2.3 Report of Sales Successful offerors will be required to provide a quarterly report of sales by line item, no later than 60 calendar days after the end of each calendar quarter ending March, June, September and December. The report shall include, but not be limited to name of VAMC where implantation is performed, date of implantation, description of item sold, model and serial number of the implanted items, price of each item. Reports shall be sent electronically to the contracting officer/contract specialist at Kimberly.Cowan-Tucker2@va.gov and Timothy.Richards@va.gov until the contractor is notified, in writing, of a different point of contact. The quarterly sales reports must be provided to the VA as indicated in clause AS 6001. This procurement is subject to the Privacy Act of 1974 and Public Law 104-191 the Health Insurance Portability & Accountability Act (HIPAA) of 1996. Note: In order to track compliance, VA requires the contractor to submit the quarterly report of sales. At time of award upon request, VA will provide the Contractor, with an electronic copy of a template that can be used for all quarterly report of sales. The Contractor agrees by submitting an offer that they will adhere to the requirement to report sales. 2.4 Contractor Selection by Medical Center. An individual medical center's decision to purchase from either or all three contractors will be based on the physician's familiarity with the manufacturer's products, as well as the manufacturer's ability to provide the level of service required by this solicitation. 3.0 DELIVERY 3.1 Delivery Requirements. The successful contractors shall provide two delivery methods. The Medical Centers will either order in the just-in-time manner indicated below or will use the Consignment Agreement Below. The purpose of the two delivery systems is to meet the needs of hospitals that perform a significant number of procedures and those that perform occasional procedures. After award, each facility that will be using the contract will inform the contractor/s of the chosen method of delivery. 3.2 - Just-in-Time Delivery -- When a device implantation is scheduled, the physician, or his or her designate, will call up a contractor's field representative and inform him or her of the implant date and time (it can be within 2 hours) and the preferred device and leads. At the scheduled time, the representative wills hand-carry the sterilized items, including instrument sets, to the place of implantation. The representative will also have, in his or her possession, a number of "back-up" devices and leads and implant accessories available to the VA physician. 3.2.1 Instrumentation Sets -- Contractor shall provide all accessories (i.e., wrenches, adaptors, connectors, introducer kits for CRT-P and CRT-D implantation, testing cables, sterile sleeves, and LV lead delivery system kits at no additional charge to the government. Based on case scheduling Contractor may be requested to have additional loaner instrumentation sets available for use by VA staff. Contractor will provide the necessary loaner instrument set for the implant procedures at no additional cost to the Government. If an instrument from the set becomes lost or damaged due to Government negligence, the Government will then be responsible to replace the damaged or lost instrument. 3.3 - Consignment Agreement - A. TITLE: Title for the consigned items shall remain with the contractor until such items are used. B. INVENTORY: Contractor agrees to furnish and maintain an inventory of sterilized implants and related supplies at the VAMC on consignment basis in accordance with the terms and conditions of the contract. Items, as well as all required instruments, and all related supplies, will be placed in the VAMC at no additional expense to the Government upon request by each VAMC. Minimum inventory levels will be proposed by the Contractor and reviewed and accepted by the Government prior to placement at the VAMC. A complete listing of model and/or part numbers will be provided to the Contracting Officer's Technical Representative (COTR) upon delivery of the initial inventory. C. INITIAL INVENTORY: A typical acceptable initial consignment inventory will include 2 each of CRT-P and CRT-D on contract, and 2 or 3 each of pacing (including LV leads) and high voltage defibrillation leads in each standard length. Actual initial inventory will be determined by each individual VAMC. Initial consignment inventory shall be placed in the medical center within ten calendar days after notification that a VAMC will be using the consignment option of the contract. Consignment inventory will be placed in a location designated by the VAMC staff. The VAMC will provide adequate space/shelving for implants, instruments, and supplies. D. INSTRUMENTATION SETS: Contractor shall provide all accessories (i.e., wrenches, adaptors, connectors, introducer kits for CRT-P and CRT-D implantation, testing cables, sterile sleeves, and LV lead delivery system kits at no additional charge to the government. Based on case scheduling Contractor may be requested to have additional loaner instrumentation sets available for use by VA staff. Contractor will provide the necessary loaner instrument set for the implant procedures at no additional cost to the Government. If an instrument from the set becomes lost or damaged due to Government negligence the Government will assume responsibility of replacing the damaged or lost instrument. E. LIABILITY: The Government assumes no liability for any items assigned to the VA Medical Center on a consignment basis until such time as a requirement for the item exists and a purchase (delivery) order is placed against this contract/consignment agreement. An exception to contractor liability is loss or damage of any consignment item by VA. F. REPLACEMENT ITEMS: After each procedure, the VAMC will provide a list of items used and the contractor will provide replacements within 48 hours. Replacements will be shipped/delivered FOB Destination. Contractor will ship products directly to VAMC at no additional charge. The contractor shall re-sterilize and/or replace, at no additional charge, any item(s) that are handled but not implanted. Contractors shall pick-up or have handled items shipped back to the sterilization facility at no expense to the Government. G. INVENTORY MAINTENANCE: All consignment inventories will be coordinated with the COTR. Contractor will remove or replace inventory as necessary. H. EXPIRING INVENTORY: Inventory having less than 90 days sterility/expiration date must be removed and replaced. A list of all products having an expiration date of less than 90 days will be provided to the COTR at the individual VAMC. These services will be completed at no additional cost to the Government. The VA is not liable for devices that are allowed to expire. I. DEFECTIVE ITEMS: Defective implants or instruments, and worn out instruments, will be replaced by Contractor at no charge to the Government, unless the Government has misused or lost the implant or instrument J. INVENTORY: Contractor's personnel will periodically (no less than once per quarter) conduct a physical inventory of the consignment inventory, with copy of inventory furnished to the COTR. Unused items will be returned to the vendor at the end of the term of this contract without reimbursement or other expense to the Government. 4.0 TECHNOLOGY REFRESH A. All implants, instruments, and accessories offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. B. If upgrades of instruments, implants, or supplies become available after award of this contract, the contractor will substitute them for the awarded items per Item C below. C. The contractor will provide to the contracting officer the following information: (1) A list of specific awarded items which shall be updated. (2) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. D. The Contracting Officer will provide the information to the Cardiac Program Office for approval. Upon approval, the contract will be modified to acknowledge the updated items. E.All new products that replace awarded items and released to the market during the term of the contract will be made available to the government at a discount price agreed to base on commercial sales practices disclosure. If pricing for new products is unacceptable, medical centers will continue to use current products on contract and contractor will be required to continue to supply the contracted item. F.All other new products that are added to a vendor's catalog and released to the market during the term of the contract will be made available to the government at a discount price agreed to base on commercial sales practices disclosure. Pricing on new technologies will be negotiated separately. 5.0 On-Site Personnel Requirement Contractor is required to have qualified personnel on site within 45 minutes of request by the VAMC and during any implant procedure if requested by medical centers. The technical representative will provide advisory assistance to VA physician in implantation of the devices. He or she will provide technical information of the contractor's products, perform standard implant testing of the devices, and provide trouble-shooting suggestions. There must be at least two representatives (one serves as the back-up) within 45 minutes of driving time to an implanting VAMC and one representative within 45 minutes of driving time available to provide clinic follow-up support for each VAMC. At the time of the award, VA will provide the vendor with a list of VAMCs that implant devices and a list of VAMC that provide device clinic follow-up care. Technical support will be available twenty four (24) hours a day for patient follow up, in-service training, and consultation on technical issues. Contractor must return telephone calls for assistance from VAMC within 15 minutes of VAMC's telephone call to the contractor. For emergency procedures, if the awarded contractors cannot supply qualified personnel within 45 minutes, medical centers may order from any supplier. At the beginning of the award period (or two weeks prior to the contract effective date) the vendor must provide: (1) names of the representatives covering each VAMC and (2) number of non-VA hospitals each representative is covering. If the vendor fails to provide the above information or the needed support the contract will be canceled. Upon award, contractor shall inform COTRs of appropriate contacts and provide phone numbers. 6.0 To Support Nationwide Service and Technical Representatives Experience and Availability all Offerors must submit: 1.List of all representatives, indicating which representative will serve which sites. Include locations from where representatives will be dispatched and provisions for back-up when a local representative is not available. 2.Describe and document in detail offeror's ability to service all of VA in 50 States, the District of Columbia, and Puerto Rico. 3.Describe and document offeror's logistics of distribution of product to VA Medical Centers within 48 hours, as well as urgent and emergency delivery. 4.Description and documentation of the general training and education backgrounds of technical representatives, including number of hours of training required and continuing education requirements. This is not a request for education requirements by individual. 5.Provide Quality Assurance Plan for technical representative 7.0 Food and Drug Administration (FDA) and other Regulatory Agencies Recall At the time of the award of the contract resulting from this solicitation, the vendor(s) will not have any outstanding actions from the FDA or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this solicitation. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the vendor from the regulatory agency will meet this requirement. Vendors must include the letters with their proposals. Items involved in a recall cannot be identified items for Award Group One Sub Groups A & B. and cannot be added onto any resultant contract until the recall is resolved. EVALUATION--COMMERCIAL ITEMS (JAN 1999) (a) (Tailored) The Government may award up to three fixed price contracts with economic price adjustments resulting from this solicitation to the responsible offeror(s) whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers and are listed in descending order of importance. The non-price evaluation factors when combined are significantly more important than Price. 1. Technical. For Award Group A the technical evaluation will be based on the top item in each sub group A & B and related leads identified per the Instructions to Offerors. Each item will be scored individually. For each factor, if the factor is present, all of the points are awarded. If the factor is not present, none of the points will be awarded. However, six factors are rated according to maximum delivered energy, charge time at ERI, information management, duration or longevity, Battery Life and LV delivery systems. In weighting these factors the government has determined the clinical relevance of the listed features. The scores for sub group A & B and related leads will be added together. No additional points are going to be given to products that exceed the requirements as defined in the evaluation matrices. When selecting the "top of the line" model to be submitted for evaluation, select those that best meet the needs of VA as defined by the matrices. 2. Price. There will be two levels of price analysis. The first analysis will be a comparative analysis of the prices offered for all items being technically evaluated. The second level will be for all other items included in the offer. For these items, price analysis of the discounts offered to the Government will be based on price reasonableness of prices offered using commercial sales practices information. See Proposal Organization. 3. Quality/Past Performance. The Government shall evaluate the Offeror's reputation for quality and past performance. By quality and past performance the Government means the Offeror's record of conforming to contract requirements and to standards of good workmanship (effort and/or endeavor); the contractor's record of forecasting and controlling costs; the contractor's adherence to contract schedules, including the administrative aspects of performance; the contractor's history of reasonable and cooperative behavior and commitment to customer satisfaction; the contractor's record of integrity and business ethics, and generally, the contractor's business-like concern for the interest of the customer. The Government shall evaluate quality/past performance on the basis of information that may be obtained from the Offeror, or from any other source such as previous commercial and Government contracts (See Attachment A). The Government may also use any relevant information in its possession or in the public domain. In the case of an Offeror without a record of relevant past performance or for whom information on past performance is not available, the Offeror may not be evaluated favorably or unfavorably on past performance (See Clause AS3029). 4. Small Disadvantage Business (SDB) Participation. Evaluation of Small Disadvantaged Business Participation will be a subjective assessment based on the offeror's SDB Participation Targets (expressed as dollars and percentages of the total value of the offer) and the extent to which the SDBs are specifically identified in the offeror's proposal. (b) Options. (Tailored) Option year prices will be evaluated using EPA procedures outlined in AS Clause 1515. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. TECHNICAL EVALUATION FOR CRT-D (WITH DEFIBRILLATION) AND CRT-P (WITHOUT DEFIBRILLATION) 1a. Technical Evaluation for CRT-D Sub Group A. An evaluation of the offered cardiac resynchronization therapy devices with and/or without defibrillation (CRT-D & CRT-P) will be performed by the CRT Technical Evaluation Team. Products will be evaluated by the presence or absence of each factor, weighed according to its clinical importance, listed below in each product line. A vendor having most of the clinically important features will receive an overall favorable technical evaluation.. Evaluation Factor Clinical Importance Weight Ventricular Tachyarrhythmia Detection 3 detection zones for therapy15 SVT discrimination Features A-V ratio SVT discrimination15 A-V timing SVT discrimination15 A-V timing SVT discrimination15 Onset SVT discrimination15 Stability SVT discrimination15 Programmable SVT discrimination in all VT zones15 Rate limit for SVT discrimination15 Mechanism to discriminate rapid VT from VF2 Dedicated VT monitoring zone5 Ventricular Tachyarrhythmia Therapy Maximum delivered energy (< 30 vs. 30-35 vs. > 35J) Maximum delivered energy 30-35 J10 Maximum delivered energy >= 35 J20 Charge time at ERI (< 12 vs. 12-15 vs. > 15 seconds) Charge time at ERI 12-15 sec5 Charge time at ERI < 12 sec20 Programmable shock wave form5 Programmable shock polarity15 Burst, Ramp, and scan ATP20 ATP during charging20 Programmable Biventricular or LV only ATP20 Programmable shock electrode combination15 Bradycardia Management Independent brady and post-shock pacing parameters 10 Pacing mode changes to single chamber in response to atrial tachycardia10 Special criteria to allow pacing mode change in response to atrial flutter2 Pacing mode designed to suppress AF1 Rate smoothing1 Any activity rate response sensor5 Dual sensor2 Automatic adjustment of sensor parameters2 Mechanism to search for native sinus rate below sensor rate2 CRT management Maximum LV pacing configurations (bipolar lead) 6 max10 Programmable Interventricular V-V timing 20 Automated algorithm to optimize V-V timing15 Automated algorithm to optimize AV delay10 Special feature to promote biventricular pacing in response to sensed PVC10 Feature to promote biventricular pacing in AF15 Ability to sense LV events (left ventricular protection period)15 Pacing output in RV automatically adjusts based on pacing threshold Beat-to-beat capture verification (V lead)5 Periodic threshold test with automatic safety margin (V lead)2 Pacing output in LV automatically adjusts based on pacing threshold Beat-to-beat capture verification (V lead)5 Periodic threshold test with automatic safety margin (V lead)2 Pacing output in atrium automatically adjusts based on pacing threshold Beat-to-beat capture verification (A lead)5 Periodic threshold test with automatic safety margin (A lead)2 Atrial sensitivity automatically adjusts2 Follow-up and Programmer Programmable guided follow-up testing5 Simultaneous ECG, electrogram, and marker channel display15 No permanent programming changes needed for lead testing10 Choice of pulse width or amplitude threshold test5 ECG strips of threshold tests showing output levels automatically saved for review5 Automatic P and R wave measurement10 Temporary programming available5 Patient specific longevity estimate10 T wave shock VF induction15 Second VF induction method10 Programmed Electrical Stimulation10 Programmable atrial EGM configuration2 Programmable ventricular EGM configuration10 Automatic patient alert for ERI20 Automatic patient alert for lead failure20 Programable alert setting for lead performance 20 Programable alert setting for lead performance 2 Automatic patient alert for VF therapy off15 Automatically adjusting capacitor reform interval5 Programmable capacitor reform interval5 Patient triggered EGM2 Painless high voltage lead impedance20 Remote monitoring capability (cannot score < 0 points for this section) Full disclosure upload (remote monitoring)50 Less than full disclosure upload (remote monitoring)10 Remote monitoring requires real-time participation of VA call center-20 Wireless remote monitoring (scheduled by VA ICD center)10 Wireless sentinel alerts (daily remote monitoring)10 Neither patient nor physician cannot initiate unscheduled remote download-15 Information Management Atrial plus ventricular EGM (dual configuration) storage20 Atrial and ventricular electrogram storage during detection, therapy and after therapy (dual chamber)10 Atrial and ventricular electrogram storage during detection and after therapy only (dual chamber)5 Pre onset EGM storage without reduction in longevity5 Ventricular (and atrial) interval plots of ICD therapy episodes20 Atrial high rate or mode switch episode storage with electrograms10 Atrial high rate or mode switch episode trending (dates, duration, etc..)5 Non-sustained episode storage with electrograms2 Total electrogram storage time (W-X-Y-Z points from shortest to longest)0 Total electrogram storage time (W-X-Y-Z points from shortest to longest)5 Total electrogram storage time (W-X-Y-Z points from shortest to longest)10 Total electrogram storage time (W-X-Y-Z points from shortest to longest)20 Long term pacing and shock lead impedance trending5 Long term P/R wave amplitude trending5 Non physiologic high rate episode counter10 Ventricular sensed events (lack of biventricular pacing)15 Long-term heart rate trending2 Long-term CHF (volume/impedance status) trending10 Physical Specs RF / wireless interrogation20 DDI volume < 36 cc20 Longevity (higher point value for fixed vs. autocapture awarded)200 DDD(R) Longevity - RV & RA 2.5V (500 ohms), LV 3.5V @ 0.4ms (1000 ohms), 100% pacing, 70 PPM, quarterly shocks DDD(R) Battery life greater than or equal to 3 but less than 4 years10 DDD(R) Battery life greater than or equal to 4 but less than 5 years50 DDD(R) Battery life greater than or equal to 5 but less than 6 years100 DDD(R) Battery life greater than or equal to 6 years150 DDD(R) Battery life autocapture ON, 100% pacing, threshold 1 mV RA & RV, 2V in LV, (impedance and shocks as above) DDD(R) Battery life greater than or equal to 3 but less than 4 years10 DDD(R) Battery life greater than or equal to 4 but less than 5 years50 DDD(R) Battery life greater than or equal to 5 but less than 6 years100 DDD(R) Battery life greater than or equal to 6 years150 LV Delivery Systems Coronary sinus cannulation tools Outer guiding catheters Left-sided delivery tools15 Right-sided delivery tools20 Number of catheter shapes / options for CS cannulation5 Breakaway homeostasis valves with a 3 way stopcock15 Atraumatic / flexible tips20 Peel-away & slittable system10 Visibility under fluoro15 Non-deflectable inner guiding catheters for CS cannulation Telescoping compatibility with outerguiding catheters10 Multiple tip shapes20 Visibility under fluoro15 Atraumatic / flexible tips20 Deflectable tools for CS cannulation10 Telescoping compatibility with outer guiding catheters5 Visibility under fluoro5 Electrogram guided tools10 CS balloon Venography catheter available10 Catheter length markers5 Visible under fluoro10 Guide wires Visible under fluoroscopy10 Guide wire torquing tool2 Stylets Visible under fluoroscopy2 Multiple stiffness options5 Finishing wire available2 LEADS LV lead Number of different LV lead curvatures/shapes for stability7 Number of LV leads with soft tips7 Points subtracted for each LV lead with an LV tip size above 5 Fr -5 Different options for fixation/stabilization within veins15 Lead deliverability via stylet10 Lead deliverability via guide wire5 Lead deliverability via guide wire and stylet10 Stylet-driven steerability10 Lead deliverability via guide wire and stylet High voltage ventricular lead (steroid eluting, dual coil) Active fixation (V lead)20 Passive fixation (V lead)2 Single coil option only (negative points for each affected lead above)-10 lead not steroid eluting (negative points for each affected lead type above)-10 Mechanism to prevent adhesions (positive points for each affected lead above)5 Points subtracted for each sheath French size above 9 required for lead and guide wire-10 Atrial lead Active fixation A lead20 Points subtracted for each sheath French size above 7 required for lead and guide wire-10 A lead not steroid eluting (negative points)-10 1b. Technical Evaluation for CRT-P Sub Group B Bradycardia Management Pacing mode changes to single chamber in response to atrial tachycardia10 Special criteria to allow pacing mode change in response to atrial flutter2 Pacing mode designed to suppress AF1 Rate smoothing1 Any activity rate response sensor5 Dual sensor2 Automatic adjustment of sensor parameters2 Mechanism to search for native sinus rate below sensor rate2 CRT management Maximum LV pacing configurations (bipolar lead) 6 max10 Programmable Interventricular V-V timing 20 Automated algorithm to optimize V-V timing15 Automated algorithm to optimize AV delay10 Special feature to promote biventricular pacing in response to sensed PVC10 Feature to promote biventricular pacing in AF15 Ability to sense LV events (left ventricular protection period)15 Pacing output in RV automatically adjusts based on pacing threshold Beat-to-beat capture verification (V lead)5 Periodic threshold test with automatic safety margin (V lead)2 Pacing output in LV automatically adjusts based on pacing threshold Beat-to-beat capture verification (V lead)5 Periodic threshold test with automatic safety margin (V lead)2 Pacing output in atrium automatically adjusts based on pacing threshold Beat-to-beat capture verification (A lead)5 Periodic threshold test with automatic safety margin (A lead)2 Atrial sensitivity automatically adjusts2 Follow-up and Programmer Programmable guided follow-up testing5 Simultaneous ECG, electrogram, and marker channel display15 No permanent programming changes needed for lead testing10 Choice of pulse width or amplitude threshold test5 ECG strips of threshold tests showing output levels automatically saved for review5 Automatic P and R wave measurement10 Temporary programming available5 Patient specific longevity estimate10 Programmable atrial EGM configuration2 Programmable ventricular EGM configuration10 Automatic patient alert for ERI20 Automatic patient alert for lead failure20 Programable alert setting for lead performance 20 Programable alert setting for lead performance 2 Patient triggered EGM2 Remote monitoring capability (cannot score < 0 points for this section) Full disclosure upload (remote monitoring)50 Less than full disclosure upload (remote monitoring)10 Remote monitoring requires real-time participation of VA call center-20 Wireless remote monitoring (scheduled by VA ICD center)10 Wireless sentinel alerts (daily remote monitoring)10 Neither patient nor physician cannot initiate unscheduled remote download-15 Information Management Atrial plus ventricular EGM (dual configuration) storage20 Pre onset EGM storage without reduction in longevity5 Atrial high rate or mode switch episode storage with electrograms10 Atrial high rate or mode switch episode trending (dates, duration, etc..)5 Non-sustained episode storage with electrograms2 Total electrogram storage time (W-X-Y-Z points from shortest to longest)0 Total electrogram storage time (W-X-Y-Z points from shortest to longest)5 Total electrogram storage time (W-X-Y-Z points from shortest to longest)10 Total electrogram storage time (W-X-Y-Z points from shortest to longest)20 Ventricular sensed events (lack of biventricular pacing)15 Long-term heart rate trending2 Long-term CHF (volume/impedance status) trending10 Physical Specs RF / wireless interrogation20 Longevity (higher point value for fixed vs. autocapture awarded)200 DDD(R) Longevity - RV & RA 2.5V (500 ohms), LV 3.5V @ 0.4ms (1000 ohms), 100% pacing, 70 PPM, quarterly shocks DDD(R) Battery life greater than or equal to 5 but less than 6 years10 DDD(R) Battery life greater than or equal to 6 but less than 7 years50 DDD(R) Battery life greater than or equal to 7 but less than 8 years100 DDD(R) Battery life greater than or equal to 8 years150
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