North Macedonia – Medical equipments, pharmaceuticals and personal care products – Medical devices and medical consumables for interventional cardiology – stents and distal embolic protection.

Medical devices and medical consumables for interventional cardiology – stents and distal embolic protection.

Lots Lot 1 — Medical devices and medical consumables for interventional cardiology – stents and distal embolic protection. Lot 2 — Coronary stent with a sinusoidal configuration and a permanent polymer coating containing a cytostatic agent from the “-limus” family (DES), with a platinum-iridium core for enhanced radiopacity, an outer cobalt-chromium layer, and platinum-iridium markers; minimum stent diameter range 2.25–4.0 mm and minimum length range 8–38 mm. Lot 3 — Coronary stent with a permanent polymer coating containing a cytostatic agent from the LIMUS family (DES), with a platinum-iridium core for enhanced radiopacity, an outer cobalt-chromium layer, and platinum-iridium markers; minimum stent diameter range 2.0–5.00 mm, with overexpansion capability up to 6.00 mm (for 4.5–5.0 mm diameters), and a minimum length range of 8–38 mm. Lot 4 — Coronary stent designed for the treatment of large-lumen blood vessels, with high radial and axial strength, made of platinum-chromium alloy, abluminally coated with a bioresorbable PLGA polymer and the cytostatic agent everolimus (DES), with a dual-layer balloon system, a diameter range of 3.5–5 mm, and a length range of 8–32 mm. The stent can be further expanded up to a maximum diameter of 6 mm. Lot 5 — Coronary stent made of platinum-chromium alloy, with a thin stent strut profile ≤81 μm, a non-linear link design with an open-cell configuration, abluminally coated with a bioresorbable PLGA polymer and the cytostatic agent everolimus (DES), with a dual-layer balloon system, a diameter range of 2.25–5 mm, and a length range of 8–48 mm, compatible with a 5F guiding catheter for all sizes. Lot 6 — Self-expanding cobalt-chromium stent for carotid arteries, compatible with a 0.014" guidewire and a 5F introducer sheath, with a straight and tapered closed-cell design, a diameter range of 6–10 mm, and a length range of 30–50 mm. Lot 7 — Coronary stent made of cobalt-chromium alloy, with an open-cell design and a biodegradable polymer coating, coated with the immunosuppressive drug sirolimus, with a stent strut thickness of 60 µm, featuring PROBIO coating (amorphous silicon carbide), a diameter range of 2.25–4 mm, and a length range of 9–40 mm. Lot 8 — Peripheral balloon-expandable stent, made of cobalt-chromium, with an OTW (over-the-wire) system, compatible with a 6F introducer sheath, with a strut thickness of 110 µm (for stents with diameters of 5–7 mm), featuring PROBIO coating, with 2 markers, on a 90, 135, and 170 cm delivery catheter, with a stent length range of 18–78 mm and a diameter range of 5–10 mm. Lot 9 — Coronary stent made of cobalt-chromium alloy, with a non-linear multi-link cell design, coated with a permanent polymer and the cytostatic agent everolimus (DES), with a diameter range of 2–4 mm and a length range of 8 mm to at least 38 mm, compatible with a 5F guiding catheter for all sizes. Lot 10 — Coronary stent made of cobalt-chromium alloy, with a multi-link, non-linear link stent design, intended for large-diameter coronary arteries, coated with a permanent polymer and the cytostatic agent everolimus (DES), with a low stent crossing profile of ≤0.039" (for a 3 mm stent diameter), a diameter range of 2.25–4 mm, and a length range of 8–38 mm, with expansion capability up to 5.5 mm for 3.5: Coronary stent made of cobalt-chromium alloy, with a multi-link, non-linear link stent design, intended for large-diameter coronary arteries, coated with a permanent polymer and the cytostatic agent everolimus (DES), with a low stent crossing profile of ≤0.039" (for a 3 mm stent diameter), a diameter range of 2.25–4 mm, and a length range of 8–38 mm, with expansion capability up to 5.5 mm for 3.5 and 4.0 mm diameters without shortening, compatible with a 5F guiding catheter for all sizes. Lot 11 — Peripheral nitinol stent system, self-expanding, with a woven mesh design, flexible and kink-resistant, intended for interventions in the femoral and popliteal arteries, with a diameter range of 4.5–7.5 mm and a stent length range of 20–200 mm, compatible with a 6F introducer sheath. Lot 12 — Self-expanding carotid stent system made of nitinol alloy, with a closed-cell design, an RX system, with a straight or tapered diameter ranging from 6.0 to 10.0 mm and lengths ranging from 20 to 40 mm, compatible with a 6F guiding introducer sheath. Lot 13 — Distal embolic protection system for carotid artery stenting, featuring technology for independent deployment of a 0.014" guidewire, three levels of wire support, and subsequent deployment of an embolic protection filter with diameters of 5 and 7.2 mm and pore size of at least 120 µm; the system includes a retrieval catheter and is fully compatible with a 6F introducer sheath or a 7F guiding cathe: Distal embolic protection system for carotid artery stenting, featuring technology for independent deployment of a 0.014" guidewire, three levels of wire support, and subsequent deployment of an embolic protection filter with diameters of 5 and 7.2 mm and pore size of at least 120 µm; the system includes a retrieval catheter and is fully compatible with a 6F introducer sheath or a 7F guiding catheter. Lot 14 — Coronary CoCr DES stent designed for long, complex, and bifurcation lesions, coated with a bioresorbable polymer containing a cytostatic agent from the “LIMUS” family, selectively applied to the abluminal surface at 3.9 μg/mm, with an open-cell design, a diameter range of 2.0–4.5 mm, and a length range of 9–50 mm. Lot 15 — Self-expanding carotid stent made of nitinol alloy, with a flexible, dual-layer micromesh closed-cell design for protection against embolization, with repositioning capability during deployment up to 50%, compatible with a 5F introducer sheath and an RX system, with a stent diameter range of 5–10 mm and a stent length range of 16–40 mm. Lot 16 — Peripheral stent-graft system, balloon-expandable, indicated for interventions in the renal and/or iliac arteries, consisting of a stainless-steel stent with an open-cell design, fully encapsulated in a single PTFE layer with a controlled pore size of 55 µm, with a diameter range of 5–10 mm and a length range of 16–59 mm, compatible with a 6–7F introducer sheath and a 0.035" guidewire, with cathet: Peripheral stent-graft system, balloon-expandable, indicated for interventions in the renal and/or iliac arteries, consisting of a stainless-steel stent with an open-cell design, fully encapsulated in a single PTFE layer with a controlled pore size of 55 µm, with a diameter range of 5–10 mm and a length range of 16–59 mm, compatible with a 6–7F introducer sheath and a 0.035" guidewire, with catheter lengths of 80 and 120 cm. Lot 17 — Coronary stent-graft system, balloon-expandable, made of cobalt-chromium alloy, intended for the management of complications during interventions, with a maximum profile of 1.25 mm, compatible with a 5F catheter for diameters of 2.5–4.0 mm and a 6F catheter for diameters of 4.5 and 5.0 mm, with lengths ranging from 15 to 26 mm. Lot 18 — Peripheral stent-graft system with high radial strength, indicated for implantation in the iliac and renal arteries for the treatment of aneurysms, acute perforations, acute ruptures, and fistulas. Made of a cobalt-chromium (CoCr) stent covered with a 203 μm ePTFE layer. Balloon-expandable, with a 5F shaft, compatible with a 0.035" guidewire, with diameters ranging from 5–10 mm, lengths ranging fr: Peripheral stent-graft system with high radial strength, indicated for implantation in the iliac and renal arteries for the treatment of aneurysms, acute perforations, acute ruptures, and fistulas. Made of a cobalt-chromium (CoCr) stent covered with a 203 μm ePTFE layer. Balloon-expandable, with a 5F shaft, compatible with a 0.035" guidewire, with diameters ranging from 5–10 mm, lengths ranging from 18–58 mm, and catheter lengths of 75 cm and 120 cm. Lot 19 — Balloon-expandable covered peripheral stent with a dual ePTFE layer, inner and outer. Made of CoCr alloy, with an open-cell design, featuring three radiopaque markers at each end of the stent and two markers on the balloon. Diameter range: 5–10 mm; length range: 17–57 mm; compatible with a 0.035" guidewire. Catheter lengths: 80 and 140 cm. Lot 20 — Self-expanding carotid stent made of nitinol, featuring technology designed to prevent plaque prolapse through the stent for permanent embolic protection, with a dual-layer design and an open-cell configuration, with a diameter range of 6–10 mm and a length range of 20–60 mm (for selected diameters). Lot 21 — Coronary bioadaptor – coronary scaffold composed of three CoCr sinusoidal arrays, coated with a drug and a bioresorbable polymer, designed to unlock the scaffold six months after implantation; diameter range: 2.25–4.0 mm; length range: 14–38 mm. Lot 22 — Coronary stent system (DES) with everolimus, featuring an ultrathin 50 µm cobalt-chromium L605 platform, coated with a biodegradable and biocompatible polymer that delivers everolimus (LIMUS family) for controlled drug release, with a hybrid cell design, equipped with platinum-iridium radiopaque markers, a rapid-exchange delivery system compatible with a 0.014" guidewire and a 5F guiding catheter,: Coronary stent system (DES) with everolimus, featuring an ultrathin 50 µm cobalt-chromium L605 platform, coated with a biodegradable and biocompatible polymer that delivers everolimus (LIMUS family) for controlled drug release, with a hybrid cell design, equipped with platinum-iridium radiopaque markers, a rapid-exchange delivery system compatible with a 0.014" guidewire and a 5F guiding catheter, with diameters ranging from 2.00–4.50 mm and lengths ranging from 8–48 mm. Lot 23 — Dedicated bifurcation stent system for side branches, with sirolimus (DES) on a 65 µm cobalt-chromium L605 platform, featuring a biodegradable polymer coating (PLGA + PLLA) for controlled drug release (~30 days), with a main-branch anchoring segment with markers for positioning at the carina and ostium (4 platinum-iridium markers), a rapid-exchange delivery system with a step balloon, compatible w: Dedicated bifurcation stent system for side branches, with sirolimus (DES) on a 65 µm cobalt-chromium L605 platform, featuring a biodegradable polymer coating (PLGA + PLLA) for controlled drug release (~30 days), with a main-branch anchoring segment with markers for positioning at the carina and ostium (4 platinum-iridium markers), a rapid-exchange delivery system with a step balloon, compatible with a 0.014" guidewire and a 5F guiding catheter, available in diameter combinations ranging from 2.50–2.50 mm to 4.00–3.50 mm and lengths ranging from 16–29 mm. Lot 24 — Tapered stent system for the treatment of long, diffuse lesions using a single stent. Stent material: cobalt-chromium L605 alloy or equivalent; stent strut thickness: 65 µm; drug (active substance): sirolimus; polymer: biodegradable and biocompatible; delivery system: Rapid Exchange (RX) system; drug dose: 1.25 µg/mm². Diameter combinations: 2.75–2.25 mm, 3.00–2.50 mm, 3.50–2.75 mm, and 3.50–3.00: Tapered stent system for the treatment of long, diffuse lesions using a single stent. Stent material: cobalt-chromium L605 alloy or equivalent; stent strut thickness: 65 µm; drug (active substance): sirolimus; polymer: biodegradable and biocompatible; delivery system: Rapid Exchange (RX) system; drug dose: 1.25 µg/mm². Diameter combinations: 2.75–2.25 mm, 3.00–2.50 mm, 3.50–2.75 mm, and 3.50–3.00 mm; length range: 30–60 mm. Lot 25 — Cobalt-chromium alloy coronary stent, multi-link, featuring a Peak-to-Valley stent design for the treatment of tapered (conically narrowed) coronary lesions with small and large diameters, coated with a permanent polymer and the cytostatic drug everolimus (DES), with a strut thickness of 81 µm, a diameter range of 2 to 5 mm, and lengths ranging from 8 to 48 mm, with the capability of expansion up: Cobalt-chromium alloy coronary stent, multi-link, featuring a Peak-to-Valley stent design for the treatment of tapered (conically narrowed) coronary lesions with small and large diameters, coated with a permanent polymer and the cytostatic drug everolimus (DES), with a strut thickness of 81 µm, a diameter range of 2 to 5 mm, and lengths ranging from 8 to 48 mm, with the capability of expansion up to 5.75 mm for diameters of 3.5–5.0 mm and expansion up to 3.75 mm for diameters of 2.0–3.25 mm without shortening. Lot 26 — Peripheral CoCr stent for BTK calcified arteries, coated with sirolimus at 1.4 μg/mm² and a fluoroacrylate trilayer coating, with drug release over 2 months (75% during the first month), open-cell design with alternating links, strut thickness of 75–85 µm, high radial strength, shortening of <3%, pre-mounted on an Rx semi-compliant balloon with a 142 cm catheter, hydrophilic coating, tip profile o: Peripheral CoCr stent for BTK calcified arteries, coated with sirolimus at 1.4 μg/mm² and a fluoroacrylate trilayer coating, with drug release over 2 months (75% during the first month), open-cell design with alternating links, strut thickness of 75–85 µm, high radial strength, shortening of <3%, pre-mounted on an Rx semi-compliant balloon with a 142 cm catheter, hydrophilic coating, tip profile of 0.016", crossing profile of 0.043"–0.051", compatible with a 0.014" guidewire and a 5F guiding catheter. Dimensions: diameter 2.0–4.5 mm; length 9–39 mm.

Buyer: PHI UNIVERSITY CLINIC FOR CARDIOLOGY AND CARDIOVASCULAR SURGERY NATIONAL CENTER FOR CARDIOVASCULAR DISEASES

Buyer country: MKD

Procedure: open

CPV code: 33000000

Full notice, tender documents and how to bid are on the official TED page (link above).