Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM - division into individual parts in accordance with the decisive biomedical - technical parameters. A detailed description of the subject of the order, including prepared technical specifications, is part of the competitive documents B.2 Description of the subject of the order.

LOT-0001
1 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
Implantable devices (pacemakers, ICDs, and extravascular ICDs, CRT systems with complete accessories including electrodes) for electro-impulse therapy of arrhythmias and heart failure with stimulation pulse maximum amplitude of 8 V; with compatibility for whole-body 1.5T and 3T MRI diagnostics throughout the service life of the device with an implanted electro-impulse generator, with the option of continuous impedance monitoring of intrathoracic fluid retention; with the possibility of home telemonitoring, with accessories and incision coverage. Possibly devices compatible with Bluetooth/BlueSync wireless technology with programming via tablet application.

Medical device name - Estimated quantity
Single-chamber pacemaker - 80 pcs
Dual-chamber pacemaker - 200 pcs
Resynchronization pacemaker - 120 pcs
Leadless pacemaker with accessories - 30 pcs
Single-chamber defibrillator - 110 pcs
Dual-chamber defibrillator - 40 pcs
Resynchronization defibrillator - 155 pcs
Extravascular defibrillator - 4 pcs
Left ventricular lead with accessories - 500 pcs
Defibrillation electrode with accessories - 160 pcs
Stimulation electrode with accessories - 700 pcs
Extravascular electrode with accessories - 4 pcs
Home monitoring system - 100 pcs
Antibacterial envelope - 35 pcs
Percutaneous introducer with hemostatic valve - 200 pcs
Intracardiac and intravascular catheter loop - 10 pcs
Introducer for physiological chamber stimulation - 100 pcs

LOT-0002
2 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
a) Implantable devices (pacemakers, ICDs, and CRT systems with complete accessories including electrodes), for electro-impulse therapy of arrhythmias and heart failure with continuous (beat-to-beat) automatic optimization of the ventricular stimulation threshold; with optimizable shape of defibrillation wave for the treatment of malignant tachyarrhythmias; with advanced programming options for ICD sensing; advanced multipoint stimulation of LV; automatic adaptive algorithms for CRT; systems for stimulating the heart's conduction system; with MRI examination compatibility with an external MRI activator and home telemonitoring potential through a standard home monitor or via smartphone with iOS or Android operating systems for specific defibrillators.

Medical device name - Estimated quantity
Single-chamber pacemaker - 75 pcs
Dual-chamber pacemaker - 230 pcs
Biventricular pacemaker - 80 pcs
Single-chamber defibrillator - 150 pcs
Dual-chamber defibrillator - 45 pcs
Resynchronization defibrillator - 155 pcs
Defibrillation electrode with accessories - 220 pcs
Stimulation electrode with accessories - 600 pcs
Home monitoring system - 20 pcs
Electrode catheter for heart conduction system stimulation - 180 pcs
Wireless stimulation system for transcatheter implantation - 20 pcs

b) Implantable ECG monitor weighing up to 3.2 grams for continuous ECG monitoring of patients, with automatic detection, quantification, and memory recording of arrhythmias; with a capacity of episodes recorded by the patient of at least 55 minutes, with the possibility of programming episode priority, and with the option of immediately sending ECG records to remote monitoring networks via smartphones operating on iOS or Android.

Medical device name - Estimated quantity
Implantable ECG recording device - 65 pcs

LOT-0003
3 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
a) Implantable devices (pacemakers, ICDs, and CRT systems) with complete accessories including electrodes for electro-impulse therapy of arrhythmias and heart failure with dual sensor based on accelerometer and minute ventilation; with the capability of monitoring respiration with detection of apneic phases; automatic algorithms to minimize ventricular stimulation; systems for stimulating the heart's conduction system; with the option to choose an electro-impulse generator with an extended lifespan; with a high-capacity ICD battery (1.9 Ah) and the capability of using a reduced version of the ICD (with a thickness of up to 1cm); with MRI examination compatibility; with options for home telemonitoring.

Medical device name - Estimated quantity
Single-chamber pacemaker - 35 pcs
Dual-chamber pacemaker - 110 pcs
Resynchronization pacemaker - 25 pcs
Single-chamber defibrillator - 120 pcs
Dual-chamber defibrillator - 30 pcs
Resynchronization defibrillator - 65 pcs
Defibrillation electrode with accessories - 100 pcs
Stimulation electrode with accessories - 160 pcs
Left ventricular introducer with accessories - 50 pcs
Electrode catheter for heart conduction system stimulation - 50 pcs
Home monitoring system - 30 pcs

b) Subcutaneous implantable defibrillators (S-ICD with complete accessories) for electro-impulse therapy of arrhythmias without the need for endocardial electrode system, with MRI examination compatibility and home telemonitoring capability.

Medical device name - Estimated quantity
Subcutaneous defibrillator - 25 pcs
Electrode for subcutaneous defibrillator - 25 pcs
Set for introducing subcutaneous electrode - 25 pcs

LOT-0004
4 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
Implantable devices (pacemakers, ICDs, CRT systems) with complete accessories including electrodes for electro-impulse therapy of arrhythmias and heart failure with the capability of minimizing right chamber stimulation (without the need to prolong AV time) and maximizing the preservation of physiological AV conduction even with the occurrence of intermittent AV blocks of all degrees; automatic detection of MRI during MRI examinations; with specific algorithms for the treatment of slow ventricular tachycardias (allowing discrimination, therapy, but also stimulation in slow VT zone); with the possibility of monitoring respiration with detection of apneic episodes; with the capability of using myocardial contractility sensor for automatic optimization of CRT; with MRI examination compatibility; with home telemonitoring options for all ICD and CRT systems, as well as selected models of pacemakers.

Medical device name - Estimated quantity
Single-chamber pacemaker - 40 pcs
Dual-chamber pacemaker - 100 pcs
Single-chamber defibrillator - 20 pcs
Dual-chamber defibrillator - 10 pcs
Biventricular defibrillator - 20 pcs
Stimulation electrode with accessories - 5 pcs
Stimulation electrode for left chamber stimulation - 5 pcs
Atrial stimulation electrode with contractility sensor - 10 pcs
Home telemonitoring system - 20 pcs
Defibrillation electrode - 10 pcs

LOT-0005
5 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
a) Implantable devices (pacemakers, ICDs, and CRT systems) with complete accessories including electrodes for electro-impulse therapy of arrhythmias; with the capability of sensing atrial activity via ventricular electrode to detect atrial arrhythmias and stimulation in AV blocks; with a sensor capable of responding to emotional stress; with algorithms to minimize ventricular stimulation; with systems for stimulating the heart's conduction system; with MRI examination compatibility with automatic detection of MRI environment; with home telemonitoring options.

Medical device name - Estimated quantity
Single-chamber pacemaker - 80 pcs
Dual-chamber pacemaker - 220 pcs
Resynchronization pacemaker - 120 pcs
Single-chamber defibrillator - 180 pcs
Dual-chamber defibrillator - 35 pcs
Resynchronization defibrillator - 140 pcs
Defibrillation electrode with accessories - 300 pcs
Stimulation electrode with accessories - 1300 pcs
Home Monitoring system - 50 pcs

b) Implantable programmable and non-invasive interrogatable recording devices with long durability (over 5 years) for continuous 3-vector ECG monitoring with the capability of automatic detection, quantification, and memory recording of arrhythmias and telemetric interrogation based on data transmission over a GMS network with automatic reporting every 24 hours without active patient participation; compatibility for MRI examination in magnetic fields of 1.5 and 3 T.

Medical device name - Estimated quantity
Implantable ECG recording device - 50 pcs
Recorder accessories - 50 pcs

LOT-0006
6 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
a) Implantable programmable and mini-invasive interrogatable (max volume up to 1.4 cm3) recording devices for continuous ECG monitoring of patients suspected of otherwise undiagnosed brady- and tachyarrhythmic disorders with the capability of automatic detection, quantification, and memory recording of arrhythmias, with compatibility for whole-body 1.5T and 3T MRI examinations throughout the device's service life and the option for home monitoring and patient activator, with a lifespan of at least 3 years. Devices compatible with Bluetooth/BlueSync wireless technology and programmed through a tablet application. Filtering episodes sent via home monitoring using artificial intelligence.

Medical device name - Estimated quantity
Implantable ECG recording device - 110 pcs

b) Implantable devices (pacemakers with complete accessories including electrodes) for electro-impulse therapy of arrhythmias with special regard to the prevention of vasovagal syncope and prevention of paroxysmal atrial tachycardias, with the ability to stimulate impulses with a maximum amplitude of 7.5 V, with compatibility for whole-body 1.5T and 3T MRI diagnostics throughout the device's lifetime, without limiting the scanning area and with the function of automatically disabling MRI mode after 24 hours.

Medical device name - Estimated quantity
Single-chamber pacemaker - 20 pcs
Dual-chamber pacemaker - 20 pcs
Stimulation electrode for permanent atrial stimulation - 20 pcs
Stimulation electrode for permanent ventricular stimulation - 20 pcs

LOT-0007
7 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
Materials and accessories for extracting pacing and defibrillation electrodes from the heart and vessels with special emphasis on mechanical extraction systems.

Medical device name - Estimated quantity
Guide wire standard for extraction - 1100 pcs
Lockable and unlockable guide wire - 100 pcs
Mechanical extraction introducer - 50 pcs
Rotating mechanical extraction introducer - 120 pcs
Other accessories for extraction - 10 pcs
Loos and extraction loops - 10 pcs

LOT-0008
8 part - Implantable Electro-Impulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SHM.
Special medical materials and accessories for extracting pacing and defibrillation electrodes from the heart and vessels with special emphasis on laser extraction systems.

Medical device name - Estimated quantity
Set for mechanical or laser-assisted extraction of permanent endocavitary pacing or defibrillation electrodes - 5 pcs
Set for laser or controlled rotation-assisted extraction of permanent endocavitary pacing / defibrillation electrodes - 5 pcs
Occlusive balloon catheter - 5 pcs