Implantable electroimpulse devices, systems for cardiac resynchronization, and implantable ECG recorders - SZM - divided into individual parts in accordance with the determining biomedical-technical parameters. A detailed description of the subject of the contract, including the developed technical specifications, is part of the competitive documents B.2 Description of the subject of the contract.
LOT-0001
Part 1 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
Implantable devices (pacemakers, ICDs, extravascular ICDs, CRT systems with complete accessories, including electrodes) for electroimpulse therapy of heart rhythm disorders and heart failure with the ability to stimulate with maximum amplitude impulses of 8 V; compatible with whole-body 1.5T and 3T MRI diagnostics throughout the device's lifetime with the implanted electroimpulse generator, with the possibility of continuous impedance monitoring of intrathoracic fluid retention; with home telemonitoring, complete with accessories and incisional coverage. Possibly devices compatible with Bluetooth/BlueSync wireless technology with programming via a tablet application.
Medical device name - Estimated quantity
Single-chamber pacemaker - 80 units
Dual-chamber pacemaker - 200 units
Resynchronization pacemaker - 120 units
Wireless pacemaker with accessories - 30 units
Single-chamber defibrillator - 110 units
Dual-chamber defibrillator - 40 units
Resynchronization defibrillator - 155 units
Extravascular defibrillator - 4 units
Left chamber introducer with accessories - 500 units
Defibrillation electrode with accessories - 160 units
Stimulation electrode with accessories - 700 units
Extravascular electrode with accessories - 4 units
Home Monitoring system - 100 units
Antibacterial envelope - 35 units
Percutaneous introducer with hemostatic valve - 200 units
Intracardiac and intravascular catheter loop - 10 units
Introducer for physiological chamber stimulation - 100 units
LOT-0002
Part 2 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
a) Implantable devices (pacemakers, ICDs, and CRT systems with complete accessories, including electrodes), for electroimpulse therapy of heart rhythm disorders and heart failure with continuous (beat-to-beat) automatic optimization of the ventricular stimulation threshold; with optimizable defibrillation waveform shape for the treatment of malignant tachyarrhythmias; with advanced capabilities for programming ICD sensing; advanced multipoint stimulation of the left chamber; automatic adaptive algorithms for CRT; systems for stimulating the heart's conduction system; compatible with MRI examination with an external NMR mode activator and with the option of home telemonitoring through a classical home monitor or via a smartphone with iOS or Android operating systems for specific defibrillators.
Medical device name - Estimated quantity
Single-chamber pacemaker - 75 units
Dual-chamber pacemaker - 230 units
Biventricular pacemaker - 80 units
Single-chamber defibrillator - 150 units
Dual-chamber defibrillator - 45 units
Resynchronization defibrillator - 155 units
Defibrillation electrode with accessories - 220 units
Stimulation electrode with accessories - 600 units
Home Monitoring system - 20 units
Catheter for introducing the electrode for stimulating the heart's conduction system - 180 units
Wireless stimulation system for transcatheter implantation - 20 units
b) Implantable ECG monitor weighing up to 3.2 grams for continuous ECG monitoring of patients, with the possibility of automatic detection, quantification, and memory recording of arrhythmias; with a capacity of at least 55 minutes of episodes recorded by the patient, with the possibility of programming priority of episodes, with the possibility of immediate sending of ECG recordings to remote monitoring networks via a smartphone operating under iOS or Android systems.
Medical device name - Estimated quantity
Implantable ECG recording device - 65 units
LOT-0003
Part 3 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
a) Implantable devices (pacemakers, ICDs, and CRT systems) with complete accessories including electrodes) for electroimpulse therapy of heart rhythm disorders and heart failure with a dual sensor based on an accelerometer and minute ventilation; with respiratory monitoring capabilities and detection of apneic phases; automatic algorithms to minimize ventricular stimulation; systems for stimulating the heart's conduction system; with the ability to choose an electroimpulse generator with a prolonged lifespan; with a high-capacity ICD battery (1.9 Ah) and the ability to use a reduced version of ICD (up to 1 cm thick); compatible with MRI examinations; with the possibility of home telemonitoring.
Medical device name - Estimated quantity
Single-chamber pacemaker - 35 units
Dual-chamber pacemaker - 110 units
Resynchronization pacemaker - 25 units
Single-chamber defibrillator - 120 units
Dual-chamber defibrillator - 30 units
Resynchronization defibrillator - 65 units
Defibrillation electrode with accessories - 100 units
Stimulation electrode with accessories - 160 units
Left chamber introducer with accessories - 50 units
Catheter for introducing the electrode for stimulating the heart's conduction system - 50 units
Home Monitoring system - 30 units
b) Subcutaneous implantable defibrillators (S-ICD with complete accessories) for electroimpulse therapy of heart rhythm disorders without the need for an endocardial electrode system, compatible with MRI examinations and capable of home telemonitoring.
Medical device name - Estimated quantity
Subcutaneous defibrillator - 25 units
Electrode for subcutaneous defibrillator - 25 units
Set for introducing subcutaneous electrode - 25 units
LOT-0004
Part 4 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
Implantable devices (pacemakers, ICDs, CRT systems) with complete accessories including electrodes for electroimpulse therapy of heart rhythm disorders and heart failure with the possibility of minimizing right chamber stimulation (without the need for prolonged AV interval) and maximizing the preservation of physiological AV conduction even in the occurrence of intermittent AV blocks of all degrees; automatic detection of MRI during MRI examination; with specific algorithms for treating slow ventricular tachycardias (allowing discrimination, therapy, but also stimulation in the slow VT zone); with the possibility of respiratory monitoring with detection of apneic episodes; with the possibility of using a myocardial contractility sensor for automatic CRT optimization; compatible with MRI examinations; with the possibility of home telemonitoring for all ICD and CRT systems, as well as selected pacemaker models.
Medical device name - Estimated quantity
Single-chamber pacemaker - 40 units
Dual-chamber pacemaker - 100 units
Single-chamber defibrillator - 20 units
Dual-chamber defibrillator - 10 units
Biventricular defibrillator - 20 units
Stimulation electrode with accessories - 5 units
Stimulation electrode for left chamber stimulation - 5 units
Atrial stimulation electrode with contractility sensor - 10 units
System for home telemonitoring - 20 units
Defibrillation electrode - 10 units
LOT-0005
Part 5 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
a) Implantable devices (pacemakers, ICDs, and CRT systems) with complete accessories including electrodes for electroimpulse therapy of heart rhythm disorders; with the ability to sense atrial activity by ventricular electrode for detecting atrial arrhythmias and stimulation during AV blocks; with a sensor capable of responding to emotional stress; with algorithms for minimizing ventricular stimulation; 4 systems for stimulating the heart's conduction system; compatible for MRI examination with automatic detection of MRI environment; with the possibility of home telemonitoring.
Medical device name - Estimated quantity
Single-chamber pacemaker - 80 units
Dual-chamber pacemaker - 220 units
Resynchronization pacemaker - 120 units
Single-chamber defibrillator - 180 units
Dual-chamber defibrillator - 35 units
Resynchronization defibrillator - 140 units
Defibrillation electrode with accessories - 300 units
Stimulation electrode with accessories - 1300 units
Home Monitoring system - 50 units
b) Implantable programmable and non-invasive interrogatable recording devices with long service life (over 5 years) for continuous 3-vector ECG monitoring with the possibility of automatic detection, quantification, and memory recording of arrhythmias and telemetry interrogation based on data transmission over the GMS network with automatic message sending every 24 hours without patient’s active participation; compatible for MRI examination in magnetic fields of 1.5 and 3 T.
Medical device name - Estimated quantity
Implantable ECG recording device - 50 units
Accessories for the recorder - 50 units
LOT-0006
Part 6 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
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 undiagnosable brady- and tachyarrhythmic disorders with the possibility of automatic detection, quantification, and memory recording of arrhythmias, with compatibility for whole-body 1.5T and 3T MRI examination throughout the device's lifetime, and with the option of home monitoring and a patient activator, lifespan min. 3 years. Devices compatible with Bluetooth/BlueSync wireless technology and with programming via a tablet application. Filtering episodes sent via home monitoring using artificial intelligence.
Medical device name - Estimated quantity
Implantable ECG recording device - 110 units
b) Implantable devices (pacemakers with complete accessories including electrodes) for electroimpulse therapy of heart rhythm disorders with a special focus on the prevention of vasovagal syncopes and prevention of paroxysmal atrial tachycardias, with the ability to stimulate with maximum amplitude impulses of 7.5 V, compatible with whole-body 1.5T and 3T MRI diagnostics throughout the device's lifetime, without limitation of scanning area and with the function of automatically turning off the MRI mode after 24 hours.
Medical device name - Estimated quantity
Single-chamber pacemaker - 20 units
Dual-chamber pacemaker - 20 units
Stimulation electrode for permanent atrial stimulation - 20 units
Stimulation electrode for permanent ventricular stimulation - 20 units
LOT-0007
Part 7 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
Materials and accessories for extracting stimulating and defibrillating electrodes from the heart and vessels with a special emphasis on mechanical extraction systems.
Medical device name - Estimated quantity
Standard extraction guide - 1100 units
Lockable and unlockable guide - 100 units
Mechanical extraction introducer - 50 units
Rotating mechanical extraction introducer - 120 units
Other accessories for extraction - 10 units
Loops and extraction loops - 10 units
LOT-0008
Part 8 - Implantable Electroimpulse Devices, Systems for Cardiac Resynchronization and Implantable ECG Recorders - SZM.
Special medical materials and accessories for extracting stimulating and defibrillating electrodes from the heart and vessels with a special emphasis on laser extraction systems.
Medical device name - Estimated quantity
Safety set for mechanical or laser-assisted extraction of permanent endocavitary stimulating or defibrillating electrodes - 5 units
Extraction set for laser or guided rotation-assisted extraction of permanent endocavitary stimulating/defibrillating electrodes - 5 units
Occlusive balloon catheter - 5 units