North Macedonia – Medical equipments, pharmaceuticals and personal care products – Medical Consumables for Interventional Procedures – Introducer Sheaths, Guidewires, Catheters and Other Medical Consumables

Opportunity description

Medical Consumables for Interventional Procedures – Introducer Sheaths, Guidewires, Catheters and Other Medical Consumables Introducer (Set) for Femoral Arterial Access consisting of a hydrophilic introducer sheath with a length of 10 cm and a diameter ranging from 4 to 9 Fr, with an anti-kink layer, haemostatic valve, dilator, 45 cm guidewire with a diameter of 0.038", and a compatible 18G metal needle with a length of 7 cm for femoral puncture. Introducer (Set) for Radial Arterial Access consisting of a hydrophilic introducer sheath with a diameter ranging from 4 to 6 Fr, with an anti-kink layer and a length of 10 to 25 cm, dilator, haemostatic valve, plastic guidewire with a length of 45 to 80 cm and a diameter of 0.025", 20G puncture cannula with a length of 32 mm, 2.5 mL syringe. IHydrophilic Guiding (Sheath) Introducer for Peripheral Interventions with a length ranging from 45 to 90 cm, with a choice of straight or curved tip, with an outer diameter ranging from 5 to 8 Fr (inner diameter of at least 2.2 mm for 6Fr), with a steel coil for anti-kink support and an X-ray-visible marker at the tip, an inner PTFE layer and an outer nylon layer, coated with a hydrophilic layer over 5 and 35 cm at the distal end, with a Tuohy-Borst Sidearm or Cross-cut valve, compatible with 0.038" guidewire.syringe. Hydrophilic Guidewire with a hybrid design for peripheral interventions. Constructed with a nitinol core with a tapered tip with a 25 cm polyurethane coating, an X-ray-visible marker, and the remaining section with a PTFE spiral coating with a hydrophilic layer. Tip design with 1 cm flexibility for diameters of 0.014 and 0.018 inches and 5 cm for a diameter of 0.035 inches. Lengths ranging from 180 to 300 cm. Diagnostic Catheters for Access to Cervical Arteries and Cerebral Access with various SIMMONS curves (1, 2, 3), diameter ranging from 4 to 6 Fr, inner diameter for 5 Fr of 0.047 inches, length ranging from 100 cm to 125 cm, with double braided wire support. Compatible with 0.038" guidewires. Coronary Microcatheter with hydrophilic coating, length ranging from 130 cm to 150 cm, distal outer diameter of 1.8 Fr, proximal outer diameter of max. 2.6 Fr, compatible with 0.014-inch guidewire. With a tapered lumen and a gold X-ray-visible marker at the tip. Peripheral Support Catheter with double inner braid and 3 X-ray-visible markers positioned at 4 and 6 cm from the tip for precise measurement of the lesion and positioning of a stent or balloon. Diameters of 2.6 Fr and 4 Fr, compatible with 0.018" and 0.035" guidewires, lengths of 60, 90, 135 and 150 cm. With a straight or 30-degree curved tip. Radial Compression Band for Haemostasis Following Radial Access, with visibility of the puncture site and selective compression of the radial artery, based on inflation using a dual-balloon system, supplied with a 25 mL syringe, adjustable size, and a choice of dimensions. Temporary Transvenous Pacing Electrode for electrical stimulation, bipolar, with a pole-to-pole distance of 10 mm, with balloon and gold-plated pins. Diameter compatible with a 5 Fr introducer and length of 110 cm, with depth markers every 10 cm. The set shall also include an appropriate syringe. Central Venous Pressure Set with a 7 Fr double-lumen polyurethane catheter with a soft atraumatic tip, lumen size 16G/16G, outer diameter of 2.5 mm and length of 20 cm, transparent additional extension with side clamp, flexible steel J-tip guidewire measuring 0.9 mm × 50 cm, kink-resistant, 18G Seldinger introducer needle with a length of 70 mm, radiopaque along its length, integrated movable fixation. Diagnostic Angiographic Catheters (left and right coronary, MP and Pigtail), with a diameter ranging from 4 to 6 Fr, made of polyamide with polyurethane elastomer or similar polymers, with double-braided support, atraumatic tip and lengths of up to 110 cm for some curves. Inner diameter for 5 Fr of 0.046–0.047 inches. Compatible with 0.038" guidewires. Coronary Balloon Catheters for dilatation and CTO, semi-compliant, hydrophilic-coated, with a low-profile tip of 0.41 mm, with two markers on the balloon and two depth markers on the shaft, diameter ranging from 1.00 mm to 4.00 mm, length ranging from 5 mm to 40 mm, shaft length of 145 cm, proximal diameter of 1.9 Fr. Introducer Sheath 4, 5 & 6 Fr, lengths of 45, 65 and 90 cm (straight and crossover type), compatible with a 0.035" guidewire, reinforced with steel wire and kink-resistant, with a hydrophobic coating on the shaft of the 5 and 6 Fr (distal 30 cm) for easier navigation, dimensions of the inner and outer diameter of the introducer sheath: 4 Fr 1.63/2.08 mm, 5 Fr 1.93/2.44 mm, 6 Fr 2.29/2.79 mm. Drug-Coated Balloon Catheter for coronary interventions with sirolimus, based on a semi-compliant platform for localized coronary drug delivery, using sirolimus (3.0 µg/mm²) with solid lipid nanoparticle (SLN) technology for controlled and targeted drug transfer without permanent implantation; with a rapid-exchange system compatible with a 0.014" guidewire and a 5 Fr guiding catheter, with a usable catheter length of 142 cm; with platinum/iridium radiopaque markers, a PTFE-coated proximal shaft and brachial/femoral shaft markers at 90 cm and 100 cm; diameters ranging from 2.00 to 4.50 mm and lengths ranging from 9 to 30 mm. System for Converting Standard Introducer Sheaths to Sheathless Radial Access, consisting of two dilators compatible with 0.021 and 0.035 guidewires, 6 and 7 Fr, maximum outer diameter of 0.070"–0.078", length of 136 cm, with a 20 cm hydrophilic-coated tip. Includes a cannula needle and a mini hydrophilic nitinol wire. Drug-Coated Peripheral Balloon Catheter for PTA coated with the drug paclitaxel, at a dose of 3.0 μg/mm², on a Butyryl-tri-hexyl citrate (BTHC) carrier, with two platinum-iridium markers, balloon diameter of 2–7 mm and balloon length of 40–120 mm, catheter lengths of 90, 130 and 150 cm. Hydrophilic Balloon Dilatation Catheter constructed from a semi-crystalline polymer, OTW system, catheter lengths of 90, 130 and 170 cm, balloon diameter of 3–12 mm, with different balloon lengths ranging from 20 to 250 mm, compatible with a 0.035" guidewire, with two markers, compatible with 5 Fr, 6 Fr and 7 Fr introducers. Coronary PTCA Dilatation Balloon Catheter for predilatation, with hydrophilic coating. To have an ultra-low tip profile of 0.017 inches and a crossing profile of 0.026 inches. To feature OptiLEAP™ or equivalent balloon material. To have platinum-iridium markers. To be available in Monorail™ and Over-the-Wire configurations. To be available in sizes ranging from 1.2 mm to 5.0 mm and lengths ranging from 8 mm to 40 mm. Balloon Catheter for Aortic Valvuloplasty with a diameter ranging from 16 mm to 25 mm (including 25 mm), lengths ranging from 25–60 mm (different lengths for different diameters); with a low profile, balloons with a diameter of up to 20 mm (including 20 mm) to be compatible with 8 Fr introducers; with a rated burst pressure of minimum 4 atmospheres for all diameters; compatible with a 0.035" guidewire; catheter length of minimum 110 cm. Set for Interventions consisting of a balloon pump with an ergonomic handle, working pressure of 30 atm, pressure control mechanism during dilatation. Then a Y-connector, insertion needle, torque device High-Pressure Resistant Tubing with a minimum pressure resistance of 84 bar (1200 psi), intended for angiography with an injector, with a rotating male/female adapter, made of transparent polyurethane, minimum length of 100 cm. 150 mL Contrast Injection Syringe for Angiomat (the Angiomat available at the clinic is Liebel-Flarsheim) or equivalent, made of transparent polyurethane, high-pressure resistant, with a Luer-Lok connector at the tip for connection to pressure tubing and a rubber plunger. Hydrophilic Introducer Sheath with a superior haemostatic valve to prevent leakage, a dilator locking mechanism for easy retention of the desired position, with an X-ray-visible marker (band) at the tip, the body reinforced with a coil, minimum diameter range from 12 to 26 Fr, and working lengths of 28 cm and 64 cm. Guidewire for Below-the-Knee Peripheral Interventions, with a hybrid design, steel core and nitinol tip, suitable for shaping, with hydrophilic coating on the polymer, with at least 3 cm visible, tip weight ranging from 2.8 to 3.5 g, diameter of 0.014 inches and length ranging from 190 to 300 cm. Guidewire for Coronary Interventions made of nitinol alloy, intended for routine interventions, with a diameter of 0.014 inches, length ranging from 190 to 300 cm, flexible tip with a weight ranging from 0.6 to 0.8 g, with a 3 cm X-ray-visible coil section, with a ribbon-style tip for shaping, tip coil, and a predefined straight or curved tip shape. The guidewire may have a hydrophilic or hydrophobic coating at the tip. Guidewire for Coronary Interventions made of steel alloy, with a "Durasteel" core, hydrophilic, with a 20–30 cm polymer sleeve from the tip, for highly tortuous arteries, with a diameter of 0.014", length ranging from 190 to 300 cm, with different degrees of tip support (LS, MS, Extra Support), with a full polymer coating and different tip weights ranging from 0.8 to 1.2 g. Tip style – core-to-tip – from the core to the tip, in one continuous piece, for better control, with 3 cm X-ray visibility at the tip. GGuidewire for Coronary Interventions made of stainless steel (stainless steel core), for extra support during interventions. Hybrid-coated, with an uncoated distal segment of 3 cm. To have a tip weight of 0.9 g, with a diameter of 0.014 inches (0.36 mm), length of 182 to 300 cm and a radiopaque segment of 3 cm. To be available with a straight or J-shaped tip. 0.014" Coronary Hydrophilic Workhorse Guidewire, with high flexibility for stabilisation of the guiding catheter for device delivery, constructed using SION TECC technology with a composite core and hybrid coating (2.5 cm silicone + 39.5 cm hydrophilic), flexible, atraumatic tip of 0.5 g, 3 cm radiopaque, coil length of 8.5 cm, with excellent tip response and support, length of 190–300 cm, with a straight or curved J-shaped configuration. 0.014" Coronary Guidewire with high penetration force for crossing complex lesions with severe calcification and hard fibrotic tissue, stainless steel core, tip weight of 9 g/12 g, 20 cm radiopaque tip, hydrophilic with an "uncoated ball" tip of 0.009", coil length of 20 cm, length of 190–300 cm, with a straight or curved J-shaped configuration. Balloon Catheters for Peripheral Arterial and Carotid Dilatation, RX (rapid-exchange), compatible with a 0.014" guidewire, diameter ranging from 4.0 to 7.0 mm, lengths ranging from 15 to 40 mm. Shaft length ranging from 80 to 135 cm. Material characteristics enabling rapid inflation and deflation and the ability for rapid removal from the dilatation site. Compatible with a 6 Fr guiding catheter.configuration. Percutaneous Closure System using a suture to close the punctured artery or vein following completion of procedures using large-diameter access, up to 21 Fr for arterial and 24 Fr for venous vessels. Compatible with and recommended for transfemoral haemostasis following TAVI and related procedures. Guiding Catheters for Coronary Interventions (minimum diameter range of 5 Fr, 6 Fr, 7 Fr, 8 Fr), left and right, various curves, radiopacity and a radiopaque marker (band) immediately below the tip, atraumatic tip, large inner lumen of at least 0.071" for 6 Fr, compatible with the kissing technique using two balloons, minimum catheter length of 90 cm (with the possibility of manufacturing additional curves as required). Compatible with 0.038" guidewires. Hydrophilic Catheter for Thromboaspiration in Coronary Arteries, based on a vacuum principle, 6 Fr, length up to 140 cm, compatible with a 0.014" guidewire, reinforcing steel stylet, short and soft angled tip, 1 radiopaque marker immediately adjacent to the tip and 2 radiopaque markers for positioning, supplied with two vacuum syringes and a filter basket; the catheter is also indicated for subselective administration of diagnostic or therapeutic agents into blood vessels with or without occlusion. Coronary Balloon Catheters for Dilatation, semi-compliant, with a low-profile tip of 0.41 mm or 0.016" for all diameters, for crossing stenoses, hydrophilic coating, compatible with a 5 Fr guiding catheter, platinum-iridium markers, RX compatible with a 0.014-inch guidewire. Minimum diameter range from 1.5 mm to 4 mm (in 0.25 mm increments for the diameter range of 2–4 mm); minimum balloon length range from 6 mm to 30 mm; all diameters to be available in all lengths from 6 mm to 20 mm; minimum catheter length of 142 cm. Balloon Catheter for Valvuloplasty, non-compliant, special design with a narrowed mid-section for precise positioning before and during inflation, platinum-iridium markers, diameter ranging from 10 mm to 30 mm and minimum length range of 30 to 60 mm. .035-inch Guidewire for TAVI Procedures (with a formed distal loop of at least 30 mm in diameter). The wire with a total length of at least 260 cm, designed for stable, atraumatic positioning of the wire in the left ventricle during the TAVI procedure. Wire stiffness greater than that of an Amplatz Ultra Stiff guidewire. Guiding Catheter Extension, "rapid exchange", compatible with 6 Fr guiding catheters, constructed of nylon with mesh support, hydrophilic coating, total length of 145 cm, reinforcing steel stylet and 25 cm tube with an inner diameter of 0.057 inches, with radiopaque markers at the ends of the tube, soft atraumatic tip. Steel Guidewire for establishing initial access and for placement of catheters, with standard support stiffness, atraumatic flexible tip with a wire-coil design, with a J-shaped or Rosen and Bentson tip configuration, diameter ranging from 0.032 to 0.038 inches and length ranging from 180 cm to at least 260 cm, with a steel core and PTFE coating. Stainless Steel Guidewire for TAVI Procedures, with pre-formed "Extra Small Curve", "Small Curve" and "Large Curve" configurations. Diameter of 0.035 inches (0.889 mm) and total length of 275 cm. Intended for the introduction and placement of interventional devices in the cardiac chambers, including transcatheter aortic valve devices. To have a stainless steel core and stainless steel spring coil with LUBRIGREEN™ PTFE or equivalent coating. Distal end of 16 cm for the "Extra Small" and "Small Curve" configurations, and 18 cm for the "Large Curve" configuration. To have a tapered core diameter of 0.027", 0.013" and 0.007".PTFE coating. Coronary Balloon Catheters – NC (Non-Compliant) for post-dilatation of large coronary arteries with hard, calcified lesions and occlusions and for post-dilatation within the LM stent. Compatible with a 0.014-inch guidewire. Diameter ranging up to 5.5 and 6 mm, and lengths ranging from 6 to 30 mm. RX and OTW guidewire configurations, with a low crossing profile of 0.017 inches or 0.43 mm. Peripheral Drug-Coated Balloon Catheter, coated with the drug paclitaxel, for de novo or restenotic lesions, "OTW technique"; 0.035" compatible; minimum diameter range of 4.00–12.00 mm, in 1 mm increments (up to 10 mm); lengths of 40, 60, 80, 120, 150, 200 and 250 mm; compatible with 5, 6, 7 and 9 Fr introducers; catheter lengths of 80 and 130 cm for all available balloon sizes; catheter length of 40 cm for balloons with lengths of 40, 60 and 80 mm; nominal pressure of 8 atm. OTW Balloon Catheter made of nylon/Pebax material, semi-compliant, catheter lengths of 80, 140 and 200 cm, coated with a silicone layer, 2 radiopaque markers, tip profile of 0.036", tapered atraumatic design for the most challenging lesions, crossing profile of 0.057"–0.083", compatible with 5–6 Fr introducer, 0.035" guidewire, nominal pressure of 6–7 atm, RBP of 13–16 atm. Dimensions: diameter of 3–12 mm, length of 20–200 mm. Guidewire for Coronary Interventions made of steel alloy, with a flexible tip for interventions, with a diameter of 0.014 inches, stainless steel core, with 1:1 tip response for standard procedures, tortuous anatomies and subtotal occlusions, manufactured using ACT ONE technology consisting of two sections: a 1.5 cm silicone coating and an 18.5 cm hydrophilic coating with an exceptionally atraumatic tip, length of 190 to 300 cm, tip load of 0.5 g, 3 cm radiopaque tip, straight and J-shaped configurations. "Cutting Balloon" for severely calcified coronary lesions that cannot be dilated with conventional balloons: • Monorail or Over-the-Wire platform • Diameter ranging from 2.0 to 4.0 mm and lengths ranging from 6–15 mm • To be compatible with a guiding catheter with a maximum inner diameter of <0.058" for sizes 2.0–3.25 mm, or a guiding catheter with a maximum inner diameter of <0.068" for sizes 3.5–4.0 mm • Compatible with a 0.014" guidewire • Crossing profile <0.038" • Tip entry profile into the lesion <0.018" Guidewire for Complex Coronary Interventions for crossing long, complex lesions and chronic total occlusions using the microchannel technique. Constructed with a steel alloy core, with a one-piece core wire design and coating, with a tapered tip of 0.014"/0.010" (0.36 mm/0.23 mm), hydrophilic polymer-coated tip of 16 cm, radiopaque and tip load of 0.6–1 g, length ranging from 190 cm to 300 cm. Peripheral Microsurgical Balloon-Dilatation Catheter designed for percutaneous transluminal angioplasty of obstructive lesions, with non-compliant balloon material for dilatation and secure fixation of the atherotomes, tapered tip with a laser-formed design for facilitated entry and crossing of the lesion, as well as atherotomes, i.e. microsurgical blades for precise incisions; balloon length of 2 cm, diameters of 5–8 mm, compatible with a 0.018" guidewire, usable lengths of 50 cm, 90 cm and 135 cm, available as an Over-the-Wire (OTW) balloon catheter. Balloon Catheter for Peripheral Arteries, "OTW technique", hydrophilic coating; dual-lumen shaft; compatible with 0.035" guidewires; minimum balloon diameter range of 3–12 mm; minimum length range of 20–300 mm; compatible with 5–7 Fr introducers; catheter lengths of 80, 130 and 150 cm. Balloon Catheters for Below-the-Knee Peripheral Artery Procedures, with a low "crossing profile" for treatment of long, diffuse and distal lesions below the ankle and in the foot, OTW technique, compatible with 0.014" guidewires; minimum balloon diameter range of 1.5–4.0 mm; minimum balloon length range of 20.0–210.0 mm, "tapered" balloon with a diameter reduction of 0.5 mm from the proximal to the distal end of the balloon over a length of 210 mm for following the anatomy of the blood vessel; catheter lengths of 120 cm and 150 cm for all available balloon diameters and lengths; compatible with 4 Fr introducer for all available sizes; nominal pressure of 7 atm. Guidewire for Peripheral Interventions, for chronic ischemia below the knee, with a hybrid design, hydrophilic coating on the polymer, steel core and nitinol tip with lengths of 10 and 25 cm, straight or angled at 30°, suitable for shaping, with at least 2.5 cm radiopaque tip, tip weight ranging from 4 to 6 g, diameter of 0.014 inches and length ranging from 210 to 300 cm.7 atm. Peripheral PTA Balloon Catheter with a Paclitaxel coating (2 μg/mm²) on a 0.018" platform, designed for optimal drug transfer and minimised distal particle loss, with a lesion entry profile of 0.020" (0.51 mm), deflation time of 10 seconds, available in diameters ranging from 4 to 7 mm, lengths ranging from 40 to 200 mm and shaft lengths of 90, 135, 150 and 200 cm, suitable for treatment of high-risk lesions such as calcified stenoses, diabetes and total occlusions. 0.014" Coronary Guidewire for highly tortuous anatomies, subtotal occlusions and high-grade stenotic lesions, steel core with "rope coil" and 1:1 tip response, length of 190–300 cm, hydrophilic-coated, covered with a polymer sleeve over the core (20 cm), reinforced with a new hydrophilic Slip Coat coating over a length of 40 cm, with a tip load of 0.8 g, 3 cm radiopaque tip, with a straight or curved J-shaped configuration Hydrophilic Balloon Catheter for Peripheral Arteries, "OTW" design, catheter length of 200 cm, balloon diameter ranging from 3–7.0 mm, balloon length ranging from 20–240 mm, compatible with a 0.035" guidewire, with 2 radiopaque markers (20–150 mm) and 4 radiopaque markers (180–240 mm), NP 12 atm, compatible with 5–7 Fr introducers. Coronary Guidewire, stiff wire 0.014", hydrophobic, intended to provide maximum stiffness and support for delivery of interventional devices in extremely challenging anatomies, tip load of 0.7 g, 4 cm radiopaque tip, coil length of 4 cm, hydrophobic silicone coating, length of 180–300 cm, with a straight or J-shaped curved configuration.introducers. Guidewire for Peripheral Interventions, for extra support, diameter of 0.035 inches, steel core, tip style – core-to-tip – from the core to the tip, cover type – bare coils, hydrophobic coating, atraumatic tip suitable for shaping, 5 cm radiopaque tip, lengths of 145, 190 and 300 cm. Hydrophilic and Flexible Guiding (Sheath) Introducer for peripheral interventions, with a support coil for kink resistance and a radiopaque marker at the tip, with an inner PTFE layer. Length ranging from 45–110 cm, with an outer diameter of 4–12 Fr, with an inner diameter of 1.5–4.1 mm, with four tip configurations (straight, multipurpose, renal, double and cobra). To have a Tuohy-Borst Sidearm or Check-Flo valve, with the possibility of use for carotid and infrapopliteal procedures. Includes two dilators, 0.018" and 0.035"/0.038". Diagnostic Angiographic Catheters (left and right coronary, MP, Pigtail and others), with a diameter ranging from 4 to 6 Fr and lengths of 125 cm. Made of polyamide with polyurethane elastomer or similar polymers, atraumatic tip. Compatible with 0.038" guidewires. 1:1 torque control. Coronary Dual-Lumen Microcatheter with hydrophilic coating, length ranging up to 150 cm, with a distal outer diameter of 2.5/3.3 Fr and proximal diameter of 3.2 Fr. Guiding Catheters for Coronary Interventions with a hydrophilic layer, diameter ranging from 5 to 8 Fr, lengths of up to 125 cm, inner diameter of 0.071" for 6 Fr compatibility, as well as for 5 Fr in 6 Fr technique, atraumatic tip, with a polyamide shaft. Braided Coronary Microcatheter with hydrophilic coating, 75–95 cm, distal flexible section of 15 cm, length ranging from 130 cm to 150 cm, distal outer diameter of 1.8 Fr, maximum proximal outer diameter of 2.5 Fr, compatible with a 0.014-inch guidewire, with a tapered lumen and a gold radiopaque marker at the tip. Microcatheter for CTO, for an antegrade approach (135 cm) and retrograde approach (length 150 cm), catheter outer diameter: proximal 2.8 Fr, distal 2.6 Fr, with a tapered soft tip of 1.3 Fr. The tapered tip visible along its entire length under fluoroscopy. Catheter inner diameter: proximal 0.018", distal 0.015". Microcatheter with lengths of 135 cm and 150 cm; outer diameter of the catheter body: distal section 2.1 Fr (0.71 mm); proximal section up to 2.9 Fr (0.95 mm); outer diameter of the tip 1.3 Fr (0.44 mm); inner diameter of the catheter body 0.48 mm (0.019"); inner diameter of the catheter tip 0.38 mm (0.015"); hydrophilic coating length of 70 cm for the 135 cm microcatheter and 85 cm for the 150 cm microcatheter; reinforced catheter body with SHINKA-Shaft technology with 14 braided wires. Coronary Balloon Catheters for pre-dilatation and CTO lesions, semi-compliant, RX catheter, made of Nylon or equivalent, with hydrophilic coating and P-TECH Hypotube design, compatible with a 0.014" guidewire, 5 Fr guiding catheter, proximal shaft diameter of 1.9 Fr, distal shaft diameter of 2.36 Fr with two markers, diameter ranging from 0.85 mm to 4.00 mm, length ranging from 5 mm to 30 mm, tip profile <0.0165". NON-COMPLIANT Balloon Catheters with a low profile, for focal and long lesions, for in-stent dilatation and post-dilatation, with two markers, minimum length range of 6 mm–27 mm, and minimum diameter range of 2.0 mm–5.0 mm (with intermediate diameter sizes in 0.25 mm increments); maximum tip profile of 0.015". Paclitaxel Drug-Coated Coronary Balloon Catheter with a Paclitaxel coating ≥ 3.5 μg/mm on a biocompatible urea carrier, enabling rapid drug release within 30–60 s, platinum-iridium markers, minimum balloon diameter of 2–4 mm and minimum balloon length of 10–30 mm, catheter length of minimum 142 cm; minimum 1 clinical study published in a journal with IF ≥ 1.5. Coronary Balloon Catheters NC (Non-Compliant), RX, intended for pre-dilatation of hard, calcified, fibrotic lesions and in-stent restenosis of stents, preparation of ostial lesions, with a 3-wire system (2 integrated 0.008" nitinol wires in the balloon for rigid, resistant lesions), compatible with a 0.014" guidewire, balloon diameter of 1.75 to 4.0 mm, balloon lengths of 10, 15 and 20 mm, proximal shaft of 2.1 Fr, distal shaft of 2.7 Fr, with 2 radiopaque markers, crossing profile of 0.0334"/0.86 mm, NP 12 atm, RBP 20 atm, compatible with 5–6 Fr introducer, catheter length of 139 cm. Stiff, Extra-Stiff and Ultra-Stiff Support Guidewire made of stainless steel and PTFE-coated, with a length ranging from 145 to 300 cm, taper length of 7 to 13.5 cm, floppy tip of 1–6.5 cm, with straight and curved tips of 3 and 7.5 mm. Super-Stiff Guidewire, 0.035" and 0.038", made of stainless steel with PTFE coating. Atraumatic soft tip, 3 cm distal tip, for contralateral access. Tip options: straight, J-tip. Available sizes: 75 cm, 145 cm, 180 cm, 260 cm. Guidewire for Coronary Interventions made of "Durasteel" stainless steel, with full polymer, hydrophilic coating, diameter of 0.014", with excellent torque response with a smooth transition, length ranging from 190 cm to 300 cm, 3 cm radiopaque tip, straight and J-tip, tip style – core-to-tip – from the core to the tip, tip load of 1.5–4.1 g. Guidewire for Coronary Interventions constructed with a one-piece stainless steel core and innovative compound-taper design, providing 1:1 torque response, trackability and pushability through the most complex anatomy. The guidewire shall feature Micro-EMT Technology or equivalent, combining high penetration force, tactile feedback, flexibility and control for intraluminal crossing of complex lesions. With a tip diameter of 0.20 mm (0.008"), tip load of 3.0 gf, radiopaque tip length of 3.5 cm, covered with a spring coil, penetration force of minimum 90 gf/mm² and hydrophilic coating, the guidewire shall be suitable for crossing fibrocalcific lesions. Length ranging from 190 to 300 cm. Guidewire for Coronary Interventions constructed with a one-piece stainless steel core and innovative compound-taper design, providing 1:1 torque response, trackability and pushability through the most complex anatomy. The guidewire shall feature Micro-EMT Technology or equivalent, combining high penetration force, tactile feedback, flexibility and control, and shall be suitable for intraluminal crossing of complex lesions. With a tip diameter of 0.20 mm (0.008"), tip load of 6.0 gf, radiopaque tip length of 3.5 cm, covered with a spring coil, penetration force of minimum 180 gf/mm² and hydrophilic coating, with a length ranging from 190 to 300 cm. 0.014" Coronary Guidewire, hydrophilic, stainless steel core, straight and "pre-shape" core made of "rope coil" with 1:1 tip response, for use in tortuous anatomies and subtotal occlusions. SLIP-COAT hydrophilic coating of 52 cm, length ranging from 190 cm to 300 cm, tip load of 0.3 g, 3 cm radiopaque tip. Guidewire for Coronary Blood Vessels, 0.014", for crossing CTO, hydrophilic, with a length ranging from 200 to 300 cm, with a hybrid design (40 cm polymer sleeve with hydrophilic coating – SLIP COAT 50 cm), coil (spring) length of 11 cm, with a steel core and tip suitable for shaping, pre-shaped tip, with a tip load of 3.0 g and 3 cm radiopaque tip. Coronary Guidewire for Chronic Total Occlusions, "tapered tip" 0.011–0.012"/0.014", hydrophilic, made of stainless steel with micro-cone tip, 1 mm platinum pre-shape, tip load 2.0–6.0 g, one-piece core wire design (One-piece Core Wire), Xtrand coil, covered with a polymer Slip Coat coating over the core for 40 cm, lengths of 190, 235 and 300 cm, 15 cm radiopaque tip. Nitinol Guidewire, hydrophilic, for placement of catheters through peripheral arteries with standard or stiff support (stiff type), tapered tip with straight, angled or curved 1.5 mm, 2.0 mm and 3 mm J-style configurations. Coated with fluoroscopically visible polyurethane with tungsten and a hydrophilic layer along the entire length. Diameter ranging from 0.018 to 0.035 inches and length ranging from 80 to 400 or 450 cm. 0.035" Guidewire intended for peripheral endovascular interventions. To have an atraumatic hydrophilic tapered tip of 5 cm for reliable and safe manipulation, as well as a superelastic nitinol core to improve performance in complex anatomy. Straight and angled tips shall be available. Optimised for enhanced visualisation, with a tungsten-filled tip for improved fluoroscopic visibility, as well as movement markers on the wire for easier tracking. Working length shall be available from 260 cm to 500 cm. Paclitaxel Drug-Coated Coronary Balloon Catheter, designed for the treatment of in-stent restenosis and de novo or small-vessel disease in the coronary arteries. To feature TransPax™ or equivalent technology providing an optimal drug dose of 2.0 μg/mm². Available in sizes ranging from 2.00 to 4.00 mm and lengths ranging from 12 to 40 mm. Markers shall be made of platinum-iridium and positioned at the outer edges. Super-High-Pressure Balloon Dilatation Catheter specially designed for non-dilatable calcified interventions or fibrotic lesions. RBP 35 atm. Ultra-High-Pressure Balloon Dilatation Pump, with a pressure range of up to 55 atm. Vascular Closure System with collagen and a resorbable suture, supplied as a set with an introducer and a 70 cm guidewire, sizes ranging from 6 to 8 Fr, for transfemoral haemostasis Balloon Catheter for Valvuloplasty with a minimum diameter range of 2 mm to 30 mm, minimum length range of 10–100 mm; low-profile, balloons with diameters up to 22 mm (including 22 mm) shall be compatible with 8 Fr introducers; platinum-iridium markers; compatible with a 0.035" guidewire; catheter length up to 100 cm. 0.035" Extra-Stiff Guidewire, for complex diagnostic and interventional procedures involving large endovascular devices, providing maximum support and precise tip visualisation. Made of stainless steel with PTFE coating, with a flexible atraumatic tip of 4–15 cm, straight and J-shaped curved 3 mm, with a total length of 90–300 cm, taper length of 8–15 cm, floppy tip length of 3–7 cm. Specially Designed Snare-Shaped Wire for removal of foreign bodies from blood vessels; with a maximum diameter ranging from 2.0–35 mm; supplied as a set with an appropriate torque device, catheter and introducer/sheath. Peripheral Platinum Coils with an irregular helical shape, with diameters of 0.018" and 0.035", coated with a hydrogel polymer. Delivery wire length of 150 cm ±5%. With a detachable detachment system. Diameters ranging from 2 mm to 20 mm, lengths ranging from 2 cm to 40 cm. Hydrophilic Microcatheter for Coils with a tungsten coil for visibility, PTFE inner layer for easy delivery of particles. RO tip with two PtIr markers. Pressure resistance up to 900 psi. Supplied as a set with 0.018" and 0.021" wires with a marker for localisation. 2.0F–2.8F, 110–150 cm. Available curves: 70° and Double Angled. 7F Guiding Catheter, with an inner lumen of 0.081", proximal stainless steel section for stability and support, kink-resistant, 16 cm distal soft section for distal tracking, hydrophilic coating, 10 transitions for easier tracking and navigation. Available in straight and MP configurations, with lengths of 95, 105 and 115 cm, enabling rapid primary access when used with the selected 5F catheter (1.73 mm BER, H1 and SIM tips), as well as a radiopaque dilator, length 120–130 cm, compatible with a 0.038" guidewire. Semi-Compliant Coronary Balloon Catheter, special balloon with 4 lines of 200-micron elements, for pre- and post-dilatation with focused force for hard, calcified lesions, preparation of lesions for drug-coated balloons. Balloon diameter of 2.5–4.0 mm, balloon lengths of 8, 12 and 16 mm, compatible with a 0.014" guidewire, tip entry profile of 0.017", usable length of 138 cm, compatible with a 5F guiding catheter. Microcatheter for Coronary Interventions with enhanced guidewire control through tortuous lesions and chronic total occlusions, hydrophilic, angled, compatible with a 5F guiding catheter and 0.014" guidewire, with a usable length of up to 150 cm. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.