Ausschreibungen

Totally implantable device to detect and treat ventricular tachycardia (VT) and ventricular fibrillation (VF) automatically. The device must: 1. Detect VT and VF. 2. Discriminate VT/VF from supra-ventricular tachycardias using a variety of techniques. 3. Deliver appropriate therapy: antitachycardia pacing, low energy cardioversion, high energy defibrillation. 4. Deliver bradycardia back-up pacing. The device must be fully programmable non-invasively in all its essential parameters. The lead connectors should be compatible with international standards: IS-1 and DF-1 leads. The device must be implantable in a subcutaneous pre-pectoral pocket. Preference will be given to devices that are: 1. Small and light. 2. Equipped with more extensive criteria and proven algorithms to discriminate supra-ventricular from ventricular tachyarrhythmias. 3. Equipped with user-friendly programmers. 4. Capable of storing electrograms and a full range of diagnostics. 5. Capable of minimising ventricular pacing in the presence of a satisfactory intrinsic rhythm. Longevity, diagnostics and extra features will be taken into consideration when awarding the tender. Quote must include: 1. Cardioverter-defibrillator box. 2. A variety of defibrillator / pacing electrodes and all accessories. 3. External programmers (if not already available to the Health Department). 4. Full product specialist support, including the presence of a specialist during the actual implantation procedure. Three separate prices must be given: A. ICD with ventricular pacing/sensing only; B. ICD with atrial and ventricular pacing/sensing; C. ICD with atrial and multi-site ventricular pacing/sensing. The tenderer is to supply the following information about each of the products offered and compile it as per the following chart: 1. Volume of device cm3. 2. Weight of device g. 3. Dimensions of device (length x breadth x thickness) mm. 4. Maximum delivered energy J. 5. Charge time to maximum delivered energy (at beginning of life with formed capacitors) s. 6. Total EGM storage capacity min. 7. Longevity at 100 % pacing (2.5 V, 0.4 ms, 60 bpm, 500 W); 12 months shelf-life; quarterly shocks y. 8. Longevity reduction due to EGM pre-storage on for the life of the device y. 9. Presence of atrial fibrillation pacing suppression algorithm yes/no. 10. Presence of algorithm to reduce unnecessary ventricular pacing yes/no. Regarding the SVT differentiation algorithm in dual-chamber or CRT devices, the tenderer is to supply the following additional information as per the following chart: Name of differentiation algorithm: Sensitivity: %. Specificity: %. Positive predictive value: %. Data in above two tables is to be backed by scientific studies which must be provided. The tenderer should also supply dummy devices of identical physical size and weight (unless similar units have already been implanted previously). The Health Department reserves the right to choose to purchase the device that best fits our specifications, taking into consideration the particular clinical needs of the individual patient into which the implant will be performed. The validity of the offer should be for 12 months. Purchase will be made whenever the clinical need arises. Delivery time should be no longer than 72 hours from confirmation of order If better products have been developed from the time the tender is adjudicated to the time the device is actually needed, the Health Department reserves the right to purchase the better product.

CT 2210/2010.

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Ausschreibungen zum Thema Pacemaker