Public procurement notice: Contract Notice
Published: 2023-06-28
Buyer: Mother Theresa University Hospital Centre
Country: AL
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33140000: Medical consumables
Submission deadline: 2023-07-24
Award criteria: Lowest price

Technical requirements: (Expected Value of Contracts, for all lots): 207,998,165 (two hundred seven million nine hundred ninety eight thousand one hundred sixty five) ALL without VAT, converted into Euro according to the exchange rate of 21.06.2023: 1 947 913.14 (one million nine hundred forty seven thousand nine hundred thirteen point fourteen) euros without VAT.
Sum of prices per unit (in total for all lots): 5 499 988.00 (five million four hundred and ninety-nine thousand nine hundred and eighty-eight) ALL without VAT, converted into Euro according to the exchange rate of 21.06.2023: 51 507.66 (fifty one thousand five hundred seven point sixty six) euros without VAT.
1	ICD VR - Single chamber implantable defibrillator with defibrilation lead 7 F, Peelable Percutaneous Lead Introducer and technical support during implantation . ICD VR - Single chamber implantable defibrillator including the following features: - maximum delivered energy at least 35 Joules , algorithms for discrimination of SVTs from VTs algorithm for monitoring lead integrity with patient alert and ability of automatic reprogramming of VF detection parametrs in case of alert, trends for heart variability, daily heart rate and daily activity , 3 arrhythmia detection zones ( VT, fast VT and VF ), programmable Active Can , sound or vibration alarm  in case or battery depletion or any other condition, lead fracture, diagnostic features: episodes, markers and EMG Defibrillation lead, steroid, active fixation, with 2 defibrillation coils , choice of different length, Sheeth introducer peel away  for introducing electrode (including guide wire, syringe, dilator, nedle and introducer) 	pcs	70
2	ICD DR – dual chamber implantable defibrillator with compatible defibrillation lead, compatible atrial lead and 2 sheath ( 9 and 8 sheath ) and technical support during implanatation.(ICD-DR – defribillator kardiak I implantueshem, dydhomesh implantable defibrillator, me sonden ventrikulare dhe atriale kompatibile s idhe me 2 sheath (9 dhe 8 french) si dhe support teknik gjate implantimit) ICD  DR dual chamber implantable defibrillator with compatible defibrillation lead with the charachteristic: Maximum delivered energy for HV therapy not less than 35 J for all shocks, Arrhythmia detection zones ( VT, FVT and VF ), ATP therapy delivered before and during the capacitor charging, Automatic pacing mode switch from AAJ(R)  to  DDD(R) and vice versa or algorithm for RV pacing minimization , Wireless communication with programmer , Programmable active SVC coil and active can for VF shock delivery, SVT discriminator based on far-field morphology , At least 2 algorithms for reducing unnecessary shocks in addition to SVT discriminators , sound or vibration alarm in case or battery depletion or any other condition.	pcs	20
1	Pacemaker VVIR-rate adaptive implantable pulse generator with technology that allows safe MRI imaging for the patient in the magnetic fileds of 1.5 T and 3 T + indipendent programming of frequency adaptability for the zone of normal and for the zone of high physical load  + automatic recognition of the moment of implantation and polarity of the electrode + automatic reprogramming of the stimulation polarity and sensing  polarity + ventricular pacing lead with active or passive fixation. 	pcs	270
2	Pacemaker DDDR- atrio-ventricular rate adaptive impantable pulse generator with technology that allows safe MRI imaging for the patients in the magnetic fields of 1.5 T dhe 3 T+ automatic adjustment of stimulation voltage depending on the maesured pacing threshold + automatic adjustment of sensitivity in both heart chambers + algorithm for extension of AV delay for minimisation of venticular pacing + ("rate drop response" algorithm for recognition and therapy of vasovagal syncope) + independent programming of frequency adaptability for the zone of normal and for the zone of high physical load + trend of electrode impedance + recording of intracadiac electrograms + switching from bipolar to unipolar stimulation in case the pacing impedance is outside the set values + atrial and ventricular pacing leads with active or passive fixation. 	pcs	120
3	Pacemaker VVIR MRI with active leds with antibiotic antibacterial envelope for implantable devices designed to reduce the risk of infection. Single chamber pacemaker with programmable pacing polarity (unipolar and bipolar), amplitude threshold test, lead impedance trend (graph of daily measured lead impedance vs. time), and automatic pacing polarity switch from bipolar to unipolar pacing in case that measured lead impedance is out of programmable range (for example in case of lead fracture), recording and storage of IEGM. Steroide eluting ventricular pacing lead wich 50 % are active fixation and 50 % are with passive fixation. Antibiotic antibacterial envelope for impantable devices designed to reduce the risk of infection. + possibility of full body absorbion + elution of minocycline and rifampicine + possibility of multiple envelope size choice. 	pcs	15
4	Pacemaker DDDR MRI with corresponding active leads with Antibiotic antibacterial envelope for implantable devices designed to reduce the risk of infection. Dual chamber pacemaker rate responsible with: automatic active capture control in atrium and ventricle depending on measured pacing threshold, programmable pacing polarity (unipolar and bipolar), amplitude threshold test, lead impedance trend (graph of daily measured lead impedance vs. time including bipolar lead storage of intracardiac electrograms,EGM storage. Atrial and ventricular Steroid eluting pacing lead with active fixation. Antibiotic antibacterial envelope for implantable devices designed to reduce the risk of infection. + possibility of full body absorption +elution of minocycline and rifampicin + possibility of multile envelope size choice. 	pcs	5
5	Sheeth-introducer peel way for introducing permanent pacemaker electrode (including guide wire, syringe, dilator, needle and introducer) 8 F. 	pcs	450
8	Disposable large aligator clip style extension with safe connect used for temporary pacing procedures/resterilized. 	pcs	10
11	Lumenless lead for stimulation of HIS bundle + electrode body diameter 4.1 Fr. + multiple lengths + technology that allows safe MRI imaging for the patient in the magnetic fields of 1.5 T and 3 T. 	pcs	8
12	Catheter for HIS bundle electrode placement and fixation with fixed curved. Possibility to select different curves and catheter lengths. 	pcs	8
1	Biventricular pacemaker  (CRT-P) Compund of: 1- CRT Device; 2- Active Atrial Lead; 3- active Ventricular Lead; 4- CS Lead unipolar/bipolar; 5- CS cannulation catheter set; 6- Venogram Balloon catheter for coronary sinus; 7- Introducer 3pcs; 8- technical support and PROCTOR during implantation.CRT-P device including the following features: 1-Separate programming of pacing parameters (amplitude, pulse width) for LV and RV, at least 4 or 5 different programmable vectors for LV lead pacing , Programmable interventricular stimulation interval, Automatic lead polarity switch from bipolar to unipolar in case of lead impedance out of preset range, Possibility of parallel printing of diagnostic trends such as AT/AF daily burden, percentage of pacing, Algorithm for supression atrial fibrillation by atrial pacing in sinus rhythm, Pulmonary congestion detection and monitoring, 2-Steroid eluting atrial  pacing lead with active fixation, 3-Steroid eluting ventrikular pacing lead with active fixation, 4-Bipolar steroid eluting lead for left ventricle stimulation through coronary sinus. Implantation over the wire, possibilty of choice of different distal end curves 5-Catheter for LV introduction into coronary sinus, possibilty of choice of different distal end curves.6- Accesory set for LV introduction into coronary sinus which consists of : guidewire, slitter tool, syringe and torque,7-Balloon catheter for coronary sinus venogram with possibility of introduction over-the-wire, 8- 3 Sheeth-introducer peel away for introducing electrode (including guide wire, syringe, dilator, needle and  introducer), 2 size 7-8 F, one size 9 F. 	Pcs	50
2	Biventricular defribilator(CRT– D) with corresponding leads ( compatible right Ventricular Lead,  Atrial Lead , left Ventricular Lead , Coronary sinus cannulation set , Balloon catheter for CS ), and technical support during implantation and proctor.   -  CRT-D device including the following features:Arrhythmia detection in 3 zones ( VT, FVT and VF ), ATP therapy delivered before and during the capacitor charging , Independent programming of LV and RV pacing parameters, Independent dual zone rate response programming for normal workload and high physical exercise or is single slop, Minimum 3 pacing vectors in LV, Algorithm for ensuring CRT during ventricular sense events or algorithm  synchronies LV pacing with RV intrinsic, Programmability of at least 2 different RV sensing vectors for VT/VF detection, Patient sound alarm or vibration in case of battery depletion and lead dysfunction, SVT discriminator based on far-field morphology, sound or vibration alarm in case of battery depletion or any other condition Biventricular defribilator( CRT – D ) with corresponding leads ( compatible right Ventricular Lead,  Atrial Lead , left Ventricular Lead , Coronary sinus cannulation set , Balloon catheter for CS ), and technical support during implantation and proctor.   -  CRT-D device including the following features:Arrhythmia detection in 3 zones ( VT, FVT and VF ), ATP therapy delivered before and during the capacitor charging , Independent programming of LV and RV pacing parameters, Independent dual zone rate response programming for normal workload and high physical exercise or is single slop, Minimum 3 pacing vectors in LV, Algorithm for ensuring CRT during ventricular sense events or algorithm  synchronies LV pacing with RV intrinsic, Programmability of at least 2 different RV sensing vectors for VT/VF detection, Patient sound alarm or vibration in case of battery depletion and lead dysfunction, SVT discriminator based on far-field morphology, sound or vibration alarm in case of battery depletion or any other condition. 	pcs	20
VVIR - FULL BODY MRI 1.5T pacemaker, storage of intracardiac electrograms, with automatic switching to the rest (sleep) parameters based on the patient activity, with programmable  pacing polarity (unipolar and bipolar), impedance trend (graph of daily measured lead impedance vs. time),  and  automatic pacing polarity switch from bipolar to unipolar pacing  in case that measured lead impedance is out of programmable range including bipolar lead, longevity of more than 14 years with 60 stimulations in minute at 2.5V 100% stimulation 0,4ms pulse width.Compatible pacing lead with active or passive fixation with minimum introducer of 7F.Sheeth-introducer peel away for introducing permanent pacemaker electrode (including guide wire, syringe, dilator, needle and  introducer)of standard size from minimum 7 F. 	pcs	145