Greece – Coronary endoprostheses – SUPPLY OF ¨"CORONARY ENDOPROSTHESES¨"

Opportunity description

CORONARY ENDOPROSTHESES Stent made of cobalt-chromium alloy, with exceptionally thin struts (60μm in all diameters) and bioabsorbable polymer over the entire surface (circumferentially), available in lengths up to 48mm, and overexpansion up to 5.6 mm. Sirolimus drug release shall occur in three phases within 48 days, and it shall have a hybrid design (combination of closed and open cells) for excellent flexibility and ease of access to side branches. Everolimus drug-eluting stent made of cobalt-chromium L-605 and coated with 2 durable acrylic-fluoride polymers for left main disease and suitability for placement in vessels of different diameters, with overexpansion capability up to 5.75mm and for long lesions up to 48mm, with strut thickness of 81μm, with the possibility of discontinuing dual antiplatelet therapy at one (1) month. It shall be available in diameters from 2.0mm to 5.0mm and in lengths from 8mm to 48mm. Stent made of platinum-chromium alloy, durable polymer, approved for short-duration (1 month) administration of dual antiplatelet therapy. Stent made of cobalt-chromium alloy, with exceptionally thin struts (up to 65μm), polymer-free and with an entry profile of less than 0.017’’. Stent made of cobalt-chromium alloy, with exceptionally thin struts (up to 60-80μm) and a bioabsorbable polymer that elutes sirolimus, approved for short-duration (1 month) administration of dual antiplatelet therapy. Stent with active elution of the medicinal substance Zotarolimus, made of multilayer metal alloys (outer surface of cobalt-chromium alloy and core of platinum-iridium alloy) in a continuous sinusoidal form. It shall have a coating of durable, biocompatible polymer (BioLinx), a dual biomimetic blend of hydrophilic and hydrophobic polymer for rapid, complete and functional healing of the lesion. The design shall ensure the minimum possible longitudinal deformation without hindering easy access to side branches, with a small thickness of the prosthesis struts ≤81 μm and crossing profile 0.038” and Tip O.D. 0.023”, and a low lesion entry profile, Lesion Entry Profile 0.020”. The catheter body shall be of the hydrophilic-coated hypotube type, and it shall have a dualflex balloon with a dual-layer coating, with the inner layer enhancing flexibility and the outer layer maintaining strength. It shall have overexpansion capability up to 6.0 mm. It shall allow permanent or temporary discontinuation of dual antiplatelet therapy (DAPT) at any time after one month, particularly for patients at high bleeding risk, based on clinical studies. Stent eluting the medicinal substance Sirolimus, incorporated into a biodegradable polymer, on a cobalt-chromium alloy stent platform with a microporous surface and a two-link design between the struts. It shall be coated with low-dose Sirolimus at a ratio of 12.5μg/mm, with biodegradable polylactide-PLA polymer (duration 6-9 months), with 80% of the drug released within 28 days. It shall feature sand blasting technology and thin Cr-Co, L-605 struts, 68-79μm. It shall have an exceptionally low entry profile of 0.016", crossing profile: 0.91mm and a microporous surface (1M pores/cm2) for targeted drug release. It shall have a 2-link design ensuring maximum flexibility and access to side branches. It shall have two platinum-iridium radiopaque markers and 10-year clinical studies on efficacy and safety. Stent made of cobalt-chromium alloy—polyurethane coating, diameters 2.5-5.0mm and lengths 15-26mm, passive coating: proBIO. Stent made of cobalt-chromium alloy, with biodegradable polymer, medicinal substance Sirolimus, overexpansion capability to a diameter of up to 6.25mm and lengths up to 50 mm. It shall have a specially designed gradient coating to ensure polymer integrity, even in the event of system overexpansion. It shall be accompanied by robust clinical evidence and studies and a declaration of uniqueness for 1-month DAPT with CE-mark label, as well as studies confirming 85% endothelialization of the mesh (stent struts) from as early as the first month after its placement in the patient’s vessel, and data on use in complex lesions. Stent with active elution of the medicinal substance Zotarolimus, made of multilayer metal alloys (outer surface of cobalt-chromium alloy and core of platinum-iridium alloy) in a continuous sinusoidal form. It shall have a coating of durable, biocompatible polymer (BioLinx), a dual biomimetic blend of hydrophilic and hydrophobic polymer for rapid, complete and functional healing of the lesion. Its design shall ensure the minimum possible longitudinal deformation without hindering easy access to side branches, with a small thickness of the prosthesis struts ≤81 μm and crossing profile 0.041” and Tip O.D. 0.021”, and a low lesion entry profile, Lesion Entry Profile 0.019”. It shall be capable of expansion up to 5.0mm. It shall allow permanent or temporary discontinuation of dual antiplatelet therapy (DAPT) at any time after one month, particularly for patients at high bleeding risk, based on clinical studies. Everolimus drug-eluting stent made of cobalt-chromium L-605 and coated with 2 durable acrylic-fluoride polymers for left main disease and suitability for placement in vessels of different diameters, with overexpansion capability up to 5.5mm, with strut thickness of 81μm, with the possibility of discontinuing dual antiplatelet therapy at one (1) month. It shall be available in diameters from 2.0mm to 4.0mm and in lengths from 8mm to 38mm. Polymer-free Amphilimus-eluting stent. It shall be made of cobalt-chromium alloy, with variable strut thickness depending on the diameter, and shall have a bio-inducer coating and reservoir technology circumferentially around the struts, as well as a CE mark indication for discontinuation of dual antiplatelet therapy at one month. Coronary vascular scaffold fully bioabsorbable within 24-36 months, with no permanent metal framework remaining, with controlled local release of Sirolimus, made of Poly-L-lactide (PLLA), with a drug density of 1.25 μg/mm² and controlled release kinetics, and a Rapid Exchange (Rx) delivery system, with strut thickness of 100μm, providing adequate initial radial strength and good deliverability and navigability in complex coronary lesions, with cell geometry ensuring a balance between radial strength and flexibility, allowing access to side branches, while also bearing integrated platinum radiopaque markers at the ends for precise imaging guidance during implantation. Stent made of cobalt-chromium alloy with biocompatible, fully degradable polymer (PLLA), eluting the medicinal substance Sirolimus at a concentration of 1.25 μg/mm², with anti-restenotic action. 70% of the medicinal substance shall be released into the lesion within 30 days, and complete release of the drug into the surrounding arterial tissue shall be completed within 120 days. The endoprosthesis shall have a 6-cell design for diameters of 2.25–2.50 mm, an 8-cell design for diameters of 2.75–3.50 mm and a 10-cell design for diameters of 4.00–4.50 mm to ensure uniform distribution during expansion against the vessel walls. The endoprosthesis struts shall have a thickness of 71 μm, thus ensuring both a low profile for easy passage through tortuous anatomies/lesions and the required radial force. Cr-Co alloy stent manufactured using combined DES+DCB technology. It shall have a coating of bioabsorbable PLLA/PLGA polymer and Sirolimus and shall be loaded onto a coated balloon with Sirolimus likewise encapsulated in PLLA/PLGA polymer. It shall provide targeted release, fully covering the entire surface of the vessel stenosis with the drug. Stent eluting the medicinal substance Sirolimus, polymer-free, with dual-drug technology (Sirolimus & Probucol) on a cobalt-chromium alloy stent platform with a microporous surface and open-cell design. It shall be coated with low-dose Sirolimus at a ratio of 2.6 μg/mm2, without polymer but using probucol, which, due to its high lipophilicity, facilitates the controlled release of the drug Sirolimus. It shall have thin Cr-Co, L-605 struts, 68-79μm. It shall have a low entry profile of 0.039mm and a microporous surface (1M pores/cm2) for targeted drug release. The dual-drug technology shall be coated with shellac resin on the outer side of the stent (abluminal), enabling optimal endothelialization of the vessel and reducing the risk of thrombosis. It shall have two platinum-iridium radiopaque markers. It shall be supported by 10-year clinical studies on efficacy and safety. Stent made of platinum-chromium alloy, covered with a bioabsorbable polymer and eluting the medicinal substance Everolimus. Suitable for left main arteries and large-diameter vessels. Designed with a combination of a low dose of medicinal substance (1μg/mm2) and a poly(lactic-co-glycolic) acid (PLGA) polymer that covers solely and exclusively the outer side of the endoprosthesis struts, with a layer of only 4μm, minimizing inflammatory reactions and contributing to its faster absorption. It shall have exceptionally thin 0.0029” struts so that it is exceptionally flexible and, in combination with polymer absorption, promotes its rapid endothelialization. It shall be preloaded onto a 2-layer Pebax balloon of differing compliance, providing flexibility and low compliance. The lumen of the delivery catheter shall have rigidity proximally and flexibility in the distal section, and it shall have a proximal nitinol tube section bearing micro-cuts for increased pushability and accessibility in challenging anatomies. It shall have overexpansion capability up to 6 mm. It shall be suitable for short-duration dual antiplatelet therapy (DAPT), with the possibility of discontinuing it after the first month in patients at high bleeding risk, as shown in the current literature. Sirolimus-eluting cobalt-chromium stent with a fully bioabsorbable coating circumferentially around the struts and a differentiated number of joints depending on length for excellent apposition to the vessel. It shall have an exceptionally low entry profile ≤0.41 mm and main body profile ≤0.97 mm, strut thickness ≤60 μm in all diameters and cell area ≤19 mm² for optimal access to and protection of side branches, with availability in lengths up to 48 mm. It shall have an improved system for retaining the stent on the balloon for safe passage and placement in complex and calcified lesions. It shall have an open-cell design for optimal access to side branches, and improved pushability and navigability in tortuous vessels and complex anatomies. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.