Open procedure telematic tender within the Community, pursuant to art. 60 of Legislative Decree 50/2016 and subsequent amendments, for the conclusion of a framework agreement with multiple economic operators pursuant to art. 54, paragraph 4, lett. a) of Legislative Decree 50/2016 for the supply of medical devices for electrostimulation/pacing, extraction of infected lead catheters and electrophysiology divided into 46 lots, needed by the hospital company- Sant'Andrea University in Rome for a period of 3 (three) years.

Entirely subcutaneous implantable defibrillators with its defibrillation lead. Essential characteristics that the device must possess: at least 3 programmable sensing vectors; MRI compatibility; advanced AF diagnostics.

Absorbable antibacterial shell for the prevention of infections by implantation of devices for cardiac electrostimulation. The device must have the following essential characteristics: Local polymer-controlled release of at least two antibiotic molecules.

Long manual extraction cannulas. The device must have the following essential characteristics: Cannula entirely visible during fluoroscopy

Stiletto for lead traction and extension and anchoring accessories.

Rotating dissector for the mechanical removal of cardiac leads for stimulation and defibrillation. The device must have the following essential characteristics: Device consisting of a handpiece and a dissection blade inserted in the distal part of the device

Balloon catheter for temporary occlusion of the superior vena cava, complete with preparatory kit.

Sheaths for excimer laser removal of cardiac leads for stimulation and defibrillation. The winning company will have to make the excimer laser generator available on free loan for use, with the burden of maintenance and any consumables. Laser sheath in a single sterile package. The device must have the following essential characteristics: Different sizes of laser sheaths

Kit for removing electrodes and catheters with or without a free head by transfemoral route. The device must have the following essential characteristics: Ability to grasp intracavitary objects with or without a free head

Quadripolar, hexapular, octopular, decapular diagnostic lead leads for electrophysiological studies, with FIXED curve, in polyurethane, with related connection cables. The device must have the following essential characteristics: Minimum diameter 6 French; Platinum and/or platinum-iridium electrodes

QUADRIPOLAR, HEXAPOLAR, OCTOPOLAR, DECAPULAR ADJUSTABLE diagnostic lead leads, for electrophysiological studies in polyurethane with related connection cables The device must have the following essential features: minimum diameter 7 French, Push-Pull or Rotational piston handpiece.

ADJUSTABLE diagnostic duodecapular lead with relative connection cables. The device must have the following essential characteristics: Minimum diameter 7F, Body in thermoplastic elastomer or polyurethane, Mechanically oriented clutch mechanism, Availability of different types of curves.

SINGLE-CHAMBER leadless pacemaker complete with release kit and introducers. The device must have the following essential characteristics: SSI stimulation mode, SSIR; programmable base stimulation frequency from 40 to 120 bpm; Output ≥ 5 V amplitude output and ≥ 1 ms of lifespan

ADJUSTABLE multipolar lead for mapping the tricuspid ring and right atrium, availability of at least 20 poles and various spacings.The device must have the following characteristics essential: Minimum diameter 7F, body in thermoplastic elastomer or pebax, mechanism with bi-directional or push and pull mechanically oriented clutch.

Circular, multipolar lead for the mapping of pulmonary veins. The device must have the following essential characteristics: Minimum diameter 7F, Variable diameter model, Mechanism bidirectional micrometric mechanical orientation or push and pull

Multipolar lead for high-density mapping, active curve, equipped with at least 16 electrodes, compatible and viewable with an electroanatomical reconstruction system, with related connection cables. The device must have the following essential characteristics: Mechanical, micrometric, push and pull mechanism, or rocker

Electrocatheters for endocardial ablation, adjustable radiofrequency tip 4mm, 8 mm, pebax body with relative connection cables. It requires radio frequency generator and plates necessary for the use of the hectrocatheter. The device must have the following essential characteristics: Ergonomic handpiece with adjustment and locking mechanism, possibility of different types of curves, thermistor or thermocouple system.

Radiofrequency endocardial ablation leads with 8 mm tip with advanced capabilities to recognize intracavitary signals with related connection cables. It is required on free loan for use, radio frequency generator and plates necessary for the use of the hectrocatheter. The device must have the following essential characteristics: Ergonomic handpiece with micrometric bidirectional adjustment mechanism with automatic lock, Possibility of different configurations of the distal part with various lengths and different types of curves, Availability of 3 120° mini-electrodes integrated on the tip for pacing and EGM reading, Pebax body

Radiofrequency irrigated scaler lead, active curve, with the presence of a magnetic sensor at the tip, compatible with electroanatomical reconstruction systems. The company must provide, on free loan for use, the radio frequency generator, plates necessary for the use of the hectrocatheter and peristaltic pump. The device must have the following essential characteristics: Push and pull type micrometric handpiece, or rocker type, Possibility of different curves, Body of the lead in polyurethane or pebax

Scaler lead with contact or force sensor, radio frequency with cooled tip of 3.5 mm or 4 mm or 4.5 mm, multiple holes, compatible with electromagnetic reconstruction system and related cables of connection. The company must provide the radio frequency generator, peristaltic pump and plates necessary for the use of the lead free of charge. The device must have the following essential characteristics: Micrometric push and pull handpiece, or rocker type, Possibility of different curves.

Focal cryoablation leads, quadripolar, with 4 and 8 mm tip. The company will have to provide a cryoablation system on loan for use. The device must have the following essential characteristics: Availability of different bending radii

Balloon adjustable catheters for cryoablation of pulmonary veins, including connection cables, deflectible introducer and circular catheter for mapping pulmonary veins. The company will have to provide a cryoablation system on loan for use

Intracardiac ultrasound probe that can be integrated with a non-fluoroscopic mapping system. The company will have to provide an ultrasound machine on loan for use. The device must have the following essential characteristics: Maximum diameter 10 F, Display of endocardial structures in high resolution, Working frequency between 3 and 10 MHz, Possibility of connection of the probe to an electro-anatomical mapping system.

Leadless pacemaker with the possibility of atrial sensing complete with release kits and introducers. The device must have the following essential characteristics: SSI stimulation mode, SSIR, DDI, DDIR; programmable stimulation base frequency from 40 to 120 bpm; Output ≥ 5 V amplitude output and ≥ 1 ms duration

Transeptal puncture kit: introducer and needle. The device must have the following essential characteristics: minimum diameter 8F, minimum needle length 71 cm

Steerable introducers for the positioning of lead catheters for transeptal access to the vascular system. The device must have the following essential characteristics: Maximum diameter 11F, Availability of different types of curves, Complete with dilator, valve.

Transeptal puncture needles compatible with a steerable introducer for transeptal ablation. The device must have the following essential characteristics: Minimum length 71 cm, stainless steel needle

J-Tip Transeptal Puncture Guidewire The device must have the following essential characteristics: Diameter 0.014", Length 135cm

High density mapping lead with contact technology and magnetic sensor compatible with the electromagnetic mapping system of heart chambers. It is required to supply the mapping system for the use of the diagnostic catheter and related connection cables. The device must have the following essential characteristics: Mapping lead with minimum number of 20 poles, Max 8.5 F catheter body, Magnetic sensor for system compatibility of mapping.

Bipolar leads for temporary stimulation

External reference patch system to be applied to the patient for compatibility with the electromagnetic mapping and ablation system. It is required to supply the mapping system for the use of patches and related connection systems. The device must have the following essential characteristics: Compatibility of the patch system and electromagnetic field with high density diagnostic catheter

External reference patch system to be applied to the patient, integrated with an electromagnetic mapping system. The supply of the mapping system for the use of the Patch and related connection systems is required

External reference patch system to be applied to the patient, integrated with an electromagnetic mapping system, preferably without the need to use dedicated catheters. The supply of the mapping system for the use of Patches and related connection systems is required

Esophageal lead for esophageal temperature monitoring. Temperature control device and supplied connection cables are required. The device must have the following essential features: Availability of at least 7 sensors for temperature monitoring on the catheter

Injectable, implantable cardiac monitoring devices, complete with remote monitoring. The device must have the following essential characteristics: injectable device, MRI compatibility, presence of programmable recording modes dedicated to the management of arrhythmias; inclusive of remote monitoring system

Non-invasive arrhythmia mapping system consisting of a jacket complete with a work station for data processing. The successful bidder must provide, on free loan, a work station for the processing of data acquired by the device. The device must have the following essential characteristics: Patient wearable vest equipped with electrodes for the reconstruction of electroanatomical maps, TAC image integration system

Peel-away introducers. The device must have the following essential characteristics: Complete kit with 10 ml syringe, needle for central vascular access, guide >0.34 inch for introduction according to the Seldinger technique

External defibrillation plates. The device must have the following essential characteristics: Supplied with external, radiolucent connection cables

Biotome for endomyocardial biopsies. The device must have the following essential characteristics: Presence of dedicated introducers, for femoral access length at least 100 cm - for jugular access length at least 45 cm.

Complete pericadiocentesis kit for pericardial suction/drainage. The device must have the following essential characteristics: Complete Pericardial Aspiration/Drainage Kit

Sterile procedure kit for operating table for interventional cardiology procedures. The device must have the following essential characteristics: 200x230 mother towel with super-absorbent inner layer and waterproof outer layer, Two sterile surgical gowns, packed XL with waterproof protection in TNT and superabsorbent outer layer and waterproof interior welded to the gown with double seams and edged flaps; back of the shirt with wallet closure, Cover for PMK implant and interventional cardiology procedures (260x350) in TNT with high absorbency outer layer with superabsorbent TNT reinforcement and presence of 4 holes with transparent protective film correspondence of the inguinal region and the infraclavicular parasternal region bilaterally, 4 bowls available in various diameters and colors, 5 syringes plus needles, scalpel, 2 sterile headsets for instrument covers available in various sizes 40 sterile gauze available in various sizes, 4 sponges for patient's skin disinfection.

High-resolution intracardiac ultrasound probe. The company will have to provide an ultrasound machine on loan for use. The device must have the following essential characteristics: Maximum diameter 10 F, Display of endocardial structures in high resolution, Working frequency between 3 and 10 MHz,

Wearable defibrillator (express rental requirement for no months per year)

Implantable cardiac device for the treatment of patients with chronic heart failure, based on the delivery of cardiac contractility modulation therapy. The device must have the following essential characteristics: Biphasic pulse delivery (CCM therapy) during the absolute cardiac refractory period, cardiac device with rechargeable battery from external (dedicated charger); possibility of implantation in patients with atrial tachyarrhythmias

Implantable cardiac device for the treatment of patients with chronic heart failure, based on the delivery of cardiac contractility modulation therapy WITH THERAPY AVAILABILITY ANTI-ARRHYTHMIC, for the prevention of sudden death. The device must have the following essential characteristics: Biphasic pulse delivery (CCM therapy) during the absolute cardiac refractory period, cardiac device with rechargeable battery from external (dedicated charger); Device capable of delivering anti-tachycardic therapies

Permanent electrostimulation system in kit for His Bundle Pacing. The device must possess the following essential characteristics: System of leads and introducers for selective stimulation of the His beam

Sterile cables for measuring electrical parameters during the implantation of pacemakers or defibrillators. The device must have the following essential characteristics: Pin connection or alternatively equipped with a PSA adapter