North Macedonia - Angiography supplies - Procurement of goods - dispensable material for endovascular procedures on the peripheral vascular system.

The subject of the agreement consists of 41 separate parts -Z-Cell design with radiopaque markers on both ends of the stent - an ergonomic handle for positioning (single-hand stent deployment) - an internal port for rinsing - compatible with 0.035” wire and 6F introducer - stent length: 40-120mm - diameter: 5-8mm - catheter length: 80cm or 125cm; - the system shall be placed on a triaxial catheter for precise placement, with a working length of 130 cm - compatible with 0.035” (0.89 mm) guide wire and introducers with a maximum of 6F for all dimensions - stent diameters of 6mm and 7 mm - stent length: from 40 - 120 mm - the drug dose should not be more than 0.200 µg/mm² - the drug shall be released from the device surface in order to have a local effect on the tissue, and to reach a therapeutic concentration in a period of at least 12 months; - Rx system - compatible with 5F introducer sheath - diameter: 5-10mm - stent length: 16-40 mm - a possibility for reposition during expansion of up to 50%; - the stent diameter shall adapt to the tapered shape of the carotid artery - there shall be a possibility of repositioning the wire up to 50% of the initial placement, allowing precise stent placement - to have a closed design that provides an increased protection for covering the lesion, plaque control, angiographic results and embolic protection during device removal - available in diameters from 5 mm to 9 mm, length from 30 mm to 50 mm - catheter length: 135 cm; - OTW technique - biomimetric - diameter: 4.5-6.5 mm - stent length: 20-200 mm - 6F compatible - catheter length: 120 cm maximum; - compatible with 6F introducer sheath and 0.018” wire - Rx system - diameter: 5-8mm - stent length from 40 to 155 mm; - Straight и tapered configuration - with a so-called closed cell design - RX technique - diameter 6-10mm and length 20-40mm - compatible with 6F guiding introducer; - stainless steel - with a so-called open cell design - radiopaque markers on both ends of the stent and balloon catheter - the stent shall be placed on a balloon catheter with a length of 80-135cm - the stent shall be based on the OTW system, compatible with a guide wire 0.035” - stent diameter: 5-10mm - compatible with 6-7F introducers - stent length: from 12mm or less, to 57 mm or more; -OTW system - struts thickness: 110μm (5-7mm) - with PROBIO coating (amоrphous silicon carbidе) - compatible with a 0.035" guide wire - on a carrier available in lengths of 90,135 and 170cm - stent length: 18 - 78mm - diameter: 5-10mm; - OTW system - equipped with a mechanism for a precise placement of the stent - compatible with a 4F introducer - with amprphous silicon-carbid coating - with markers - compatible with a 0.018“ guide wire - length: 20 mm or less, to 200 mm or more -diameter: 4 mm or less to 7mm or more - struts thickness: 140 μm or less - carrier length: 80cm (+/-10cm) to 130cm (+/-5cm); - with a so-called open cell design - equipped with a single-hand ergonomic system for placement with a triaxial design with a mechanism for accurate stent positioning -OTW technique - compatible with 5F introducer and 0.035" guide wire - catheter length: 80cm-150cm - stent diameter: 5-8mm - stent length: 20-150mm and more; - the integrated balloon catheter shall have radially arranged spikes that create channels to improve vascular compliance, reduce vascular recoil, and enhance drug absorption (for controlled penetration and lesion preparation) - device diameter: 3.0 mm (for vessels 2.5 - 3.5 mm) and 4.0 mm (for vessels 3.5 - 4.5 mm) - effective catheter length of 135 cm and a hydrophilic coating on the distal segment; - a stent made of stainless steel - open cell design - fully encapsulated in a single PTFE layer with controlled porosity of 55 μm - minimum diameter range: from 5 to 10mm - minimum length range: from 16 to 59mm - compatible with 6-7 F introducer and 0.035” guide wire -catheter length: 80 and 120 cm; -OTW technique - catheter length: 50cm-150cm+/-5% - balloon length from 2cm to 12cm, or longer - inflatable balloon with a diameter from 1.5mm to 3mm, or larger - burst pressure:16atm+/-5% - accepts 0.014“ guide wire - compatible with “sheath“ of 3F; - shall be indicated for carotid, coronary, and peripheral interventional procedures - the system shall allow independent movement of the wire and enable longitudinal and rotational movement of the filter - to include an option to fracture the wire and use the remaining portion as the primary guide wire through the catheter based on the RX technique - filter dimension: 3-7mm - wire length: 320/190cm (+/-5cm), compatible with a guide wire with a diameter of 0.014-0.018" and 5F introducer; - compatible with 6F catheter, length 190 cm and 300 cm - MR 0.014 system - profile: 3.2 F (1.1mm) - nitinol filter loop; Consists of: 1. Multifunctional balloon catheter, OTW system 0.014 and 0.018, various lengths 86-93-141-142cm and 2-7mm diameter 2. PTA balloon catheter for support, available in 4F и 6F и 2-7mm diameter Used for antegrade (4F/0.014) and retrograde (6F/0.018) access; -over-the-wire (OTW) -0.035'' compatible - diameter 4.00-7.00mm, in 1 mm increments - length: 40-60-80-120-150mm - compatible with 5-6-7F introducer - catheter length: 80 and 130cm (for all available balloon sizes) - catheter length: 40cm (for balloons of 40, 60, and 80 mm length) - nominal pressure: 8 atm; -ОТW technique - compatible with 0.035’’ wires - balloon diameter: 4.0-8.0mm - length: 20.0mm - 80.0 mm, or longer - compatible with 5-7F introducers - nominal pressure: 10bar+/-5%; - ОТW technique - hydrophilic coating - “dual lumen shaft“ - compatible with 0.035’’ wires - balloon diameter: 3.0-12.0mm - length: 20.0-300.0 mm - compatible with 5-7F introducers - catheter length: 80cm,130cm; - a balloon catheter made of material that provides both trackability and high-pressure within the same balloon - compatible with 5F (1.67 mm) introducers for balloons up to 7 mm, и 6F (2.00 mm) for balloons up to 10 mm - available in balloon lengths from 20mm to 200 mm, diameters from 3mm to 12 mm and catheter length of 75cm and 135 cm; - ablation active zone length: 7cm - catheter working length: 60-100cm - with depth markers - with a 0.025“ guide wire lumen; - with a nitinol guide wire with a platinum tip, with a diameter of 0.018 “and length 40cm+/-5% - introducer with: inner diameter of 2.9F, outer diameter from 4.0 to 5.0F, and length 7 cm ±5% - echogenic needle 21G, length 4 cm (+/-5%) and echogenic tip - “Check-flow“ valve; - catheter of 2.3-2.6F that can be inserted through 4F catheter with length from 65cm to 150cm - accepts guide wire with a diameter from 0.014“ to 0.018“ - platinum and iridium markers - with either a curved or straight tip; - length: 40-135cm - infusion length: 5-50cm - diameter: 4-5F - compatible with 0.035-0.038" guide wire; - with a double inner mesh and 3 radiopaque markers positioned at 4 and 6cm from the tip for precise lesion measurement and stent or balloon positioning - diameter: 4F - compatible with 0.035” wire - length: 150cm (+/-5%) - with straight or 30º curved tip; - OTW system (for OTW technique) - compatible with 0.018“ wire - balloon diameter: from 2-7 mm, or larger - balloon length: from 40-120 mm, or longer - guiding catheters length: 90-150cm - compatible with 4F and 5F; - with lesion entry profile of 0.020" (0.51 mm) - deflation time: 10 seconds - available in diameters from 2 to 8 mm - lengths from 40 to 200 mm and - shaft lengths of 90, 135 и 150 cm; - catheter length of 90, 130 и 170 cm - balloon diameter: 3 -12 mm - with various balloon lengths from 20 to 250mm - with two markers - compatible with 5F, 6F and 7F introducer; - made of Pebax semi-compliant balloon material with hydrophilic coating or equivalent - the tip is tapered, with a lesion entry profile not larger than 0.020” (0.51 mm) - deflation time: maximum 10 seconds - balloon diameter from 2.0 mm to 10.0 mm and length from 10 mm to 220mm - the catheter shall be available with shaft lengths from 90 cm to 150 cm - compatible with 5F introducer - suitable for broad clinical applications, including carotid and post-stent interventions; The set shall contain: - 5 cc vial with adhesive - 5F delivery catheter with a minimum length of 91cm - two laser markers for high echogenic visibility - 7F introducer with a minimum length of 80cm - 5F dilator with a minimum length of 87cm - applicator with an ergonomic pistol-shaped handle, allowing controlled release of 0.10cc adhesive during application - 0.035" guide wire with J-tip - two 3cc syringes; - catheter length: 90,150,200 cm - balloon diameter: 1.5 mm to 6.0 mm - balloon length: 20-240 mm - compatible with 4-6F introducer - with 2 radiopaque markers (20-150mm) and 4 (180-240mm) - NP 12atm; - catheter length: 75,135,200 cm - balloon diameter: 3 to 7.0 mm - balloon length: 20-240 mm - compatible with 5-7F introducer - with 2 radiopaque markers (20-150mm) and 4 (180-240mm) - NP 12atm; - with length up to 110 cm, straight tip - with an outer diameter of 6F - with an inner diameter of at least 2,21mm - PTFE inner lining - with Tuohy-Borst Sidearm valve and dilator with length of 122/102cm - compatible with 0.038” wire; - embolic protection filter with dimensions of 5 and 7.2mm and pores of at least 120 microns - the system includes a collection catheter - the entire system is compatible with 5F introducer or 6F guiding catheter; - RX (rapid exchange) - diameter range from 4.0 to 7.0mm - length from 15 to 40mm - shaft length: 80-135cm - compatible with 6F guiding catheter - RBP 14atm for all sizes; - the system shall provide rotational, frontal, and expandable cutting with blades rotating at approximately 70,000 rotations per minute - to have a minimum of five frontal blades for initial lesion engagement and treatment of stenotic or occluded vessels - to use an “up/down” blade technology to allow flexibility for treating multiple vessel diameters with a single catheter - to include active and continuous mechanical aspiration to remove thrombus and debris, reducing the risk of distal embolization and ensuring optimal debulking - the cutting mechanism shall be differential, selectively removing the diseased, non-elastic tissue from the healthy vascular tissue that needs to remain protected - the catheter shall contain internal lumens for infusion, aspiration, and guide wire navigation, as well as external ports for solution and aspiration - the catheter length shall be 120 cm, 135 cm or 145 cm, depending on configuration - all variants shall be compatible with 7 F introducer and 0.014” guide wire; - two embedded Platinum-iridium markers - compatible with 5-6F introducer - balloon diameter: 2-7mm - balloon length: 40,60,80,120,150mm - catheter length: 85 and 150cm for all available balloon sizes - max guide wire 0.018'' - inflation time of at least 30 secunds - Paclitaxel drug dose: 3.0 μg/mm2; - OTW system - compatible with 0.018'' wire - balloon diameter from 2-7mm - balloon length: 40-150mm - length of the guiding catheters: 135cm - compatible with 5F-7F introducers