Italy - Osteosynthesis appliances

Description

Three-year supply of Neurosurgery devices and prostheses.
Implant for vertebral fracture reduction. Percutaneous intravertebral system in expandable titanium diam. 4.2mrn, 5.Omm and 5.8mm.With exclusively symmetrical unidirectional vertical opening and without the aid of systems that create compression inside the vertebral body. Pre-filled screwed to the introducer and in single sterile package, the cement cannulas in single sterile package, the all-inclusive vertebral access kit in single sterile package. The product must be compoletarnently disposable. High viscosity 375 p/s zirconium oxide PMMA for the system and must include dedicated mixing kit. Dedicated biopsy kit 11 G and 13 G. COMPOSED PLANT: PREPARTIZON KIT+ EXPANSION KIT+ CEMENT+ APPLICATOR+ TROCAR, Non-refillable spinal cord stimulator (SCS) 16-contact spinal cord stimulator with multiple independent current-controlled sources, with percutaneous leads of 8/16 contacts in-line. The implant should allow a choice of 8- and 16-pin percutaneous leads, extension(s), and totally implantable pulse generator controlled via a remote control and programmed via a tablet via Bluetooth. Rechargeable spinal cord stimulator for spinal cord stimulation (5C5) with 16 contacts with multiple independent current-controlled sources, with 8/16 in-line percutaneous leads.The pulse generator, equipped with 2 ports, must be able to independently manage and control the intensity of current delivered by each electrode of the lead, allowing the patient to feel the paresthesia produced by the device consistently (in terms of intensity and localization) over time, regardless of impedance increase/decrease. Also must have the ability to stimulate with different waveforms including tonic mode have the ability to combine different waveforms delivered simultaneously. Compatible with full body MRI and bluetooth connection Intersomatic titanium Trabecular cage with anterior approach, posterior and lateral made by Electron Beam Melting (EBM) technology enriched with kits for the production of bone marrow concentrate and growth factors on bone substitute paste and granule carriers that accelerate the osseointegration process essential for the long-term survival of the implant Vertebral stabilization system having all components made of carbon fiber and polymer matrix with radiolucency characteristics and no artifacts on MRI and CT scan to enable precise and accurate radiation and proton beam therapy planning for cancer patients. Compatibility with proton beam therapy Injectable resorbable bone substitute with iodinated resorbable contrast agent for treatment of bone fractures and for reinforcing synthetic media. Volumes required: 5cc, 8/10cc, 18cc Injectable resorbable bone substitute with iodinated resorbable contrast medium for treatment of bone fractures and for reinforcing means of synthesis. with antibiotic (gentamicin or Vancomycin) for treatment of bone infections or for prophylaxis to protect means of synthesis in patients at risk of infection. Sizes required: 10cc Resorbable bone substitute in patches composed of collagen and tricaicophosphate for Je posterolateraii and intersomatic arthrodesis. Sizes required: 2.5x2.5cmx0.4cm (2.5cc);2.5x5cmx0.4cm(5cc);2.5x10cmx0.4cm(lOcc) Bone substitute in biphasic synthetic granules (calcium phosphate/tricalcium phosphate) in volumes of 5,15,30cc Thoracolumbar stabilization system consisting of:Mono and polyaxial screws, with the possibility of temporarily locking the polyaxiality of the screw, without additional nuts. Cannulated and fenestrated screws diam. prox, major with conn. systems for cementation.Reduction screws. Laminar, peduncular, angled, extended-body and right- and left-offset hooks. Sterile single-use implants, with clamping nut included in package. Titanium and cobalt chrome bars, straight and precurved. Domino bar-bar open and closed; domino conn. different bars. Low-profile telescopic adjustable and articulated cross conn. Cone. lateral and iliac fixation screws. Dedicated disc preparation spreaders and instruments for deformity reduction. Pedicle screw placement system: custom guides for pedicle screw placement made with 3D printing technology. Possibility of reconstructed vertebral anatomical model for each desired level. Three lordosis angles 0°- 5°- 10' and two different plants. Self-distracting tip for easier insertion. Disc preparation tools. Open and minimally invasive use with dedicated instruments, Cages Tlif in peek coated titanium banana. Lordosis angle of at least 5' with four different plants. Self-rotation of the cage during insertion. Implant with self-distracting tip for easier insertion into the interbody space. Titanium-coated peek cages straight oblique placement. Three lordosis angles O"- 5-'10°and three different plants.Cages for Alif stand-alone titanium-coated peek locked with screws of two diam. and various lengths and integrated titanium plates with flat, long, lateral profile. Three lordosis angles 5°40'45° with two plants. Anterior retractor and ancillary instrumentation for discectomy. Cervical peek and peek coated titanium disposable cervical cage from 4rnm to 9mm(+1mm). Two anatomical profiles: flat and convex; lordosis angle 5' and 7°. Anterior cervical plate Cervical interbody cage made of PEEK characterized by anatomical shape of the upper part and equipped with preformed synthetic bone substitute. The cage has a double slit at the anterior edge to allow the subsequent introduction of two "blade" devices that allow the cage to be anchored to both the lower and upper bodies, creating a cage-plate system that provides excellent primary stability. The unique cage technology therefore allows for a zero-profile cage-plate, requiring minimally invasive surgical access due to the impactor that allows the blades to be inserted along the same axis as the cervical cage. All components are supplied already sterile, individually packaged in order to leave the user with the maximum bi-articular cervical disc prosthesis, that is, in which the central insert is able to rotate on the upper plate and translate on the lower plate, thus reproducing a rotation-translation movement. The prosthesis requires no modification of the vertebral plates (making keels and/or equalizing the plates), let alone distraction of the plates to be placed in situ. The prosthesis is supplied pre-assembled on a radiolucent PEEK holder in order to allow fast positioning within the interbody space, allowing only the prosthetic implant to be visualized during controls. The prosthesis is also available in the 4.5 mm height, which is particularly suitable for small intersomatic spaces Cage -Cervical Cage The device shall ensure fusion of the cervical spine. It will be made of PAEK and provided with titanium radiological retrievals, and the anatomical shape should result with at least 6° of lordosis. Required measurements 4,5,6,7,mm x 14 mm x 12 mm. Dedicated instrumentation will be given free of charge The system should allow minimally invasive treatment of vertebrate body fractures greatly facilitating their reduction by means of a Nitinol expander capable of allowing a multi-radius space (at least 5 ) within the bodies to be treated thus facilitating the introduction of cement . Access will be both transpeduncular and extrapeduncular with dedicated kits provided , making it possible to treat osteogenic tumors , hemangiomas or simple and complex fractures. The system shall not use expansion balloons and shall be atraumatic.The kit will be complete with PMMA cement and closed-loop battery-powered single-dedicated mixer. Measurements required : 20 and 25 mm. expander complete with dedicated access kit Latest generation ultrasound scanner with integrated spatial localization system of probes.The system thanks to virtual navigator technology synchronizes in real time images from CT, MRI, PET to ultrasound images, increasing does operator confidence in surgical practice, especially when images acquired in pre-operative phase are then susceptible to brain shifting (ex. deliquation, tumor debulking, etc.); in the latter case in fact, the system allows to correct during surgery the MRI, CT images must be provided with Disposable Kit consisting of :transducer sheath, cover and vitutrax Percutaneous dynamic stabilization system of the lumbar spine using uniaxial dynamic head screws, cannulated, self-tapping and coated with hydroxyapatite for a perfect adherence to the bone. Screws diam. 6.5 and 7.5 in lengths from 30 to 55.mm. Bars lengths from 40 to 200 mm. with the possibility of interconnection with other systems for a topping-off fusion application
Clamps and Electrodes for Radio Scalpel System for percutaneous fixation and stabilization of the spine, consisting of bars, screws and locking nuts. Screws should be titanium alloy, cannulated, self-tapping, double-threaded (cortical and spongiosa) with high-stability screwdriver attachment, with diameters from a minimum of 4.5 to a maximum of 8.5 mm, minimum 25 to maximum 100mm long; screws must have percutaneous insertion fins premounted in 2 lengths (for leaner and more corpulent patients), with additional reduction threads at least 15 mm longer than the standard screw thread;sterile fenestrated screws must be available in both single-axial and polyaxial (50* of polyaxiality). Screws must have compatibility with 5.5mm and 6.0mm diameter bars. Bars must be both straight and pre-curved, with a minimum length of 25 to a maximum of 600mm, either titanium alloy or CoCr. Lock nuts must be specially threaded to reduce radial forces that can damage the screw threads. The instrumentation, must allow for rnonlevel and multilevel reduction with a rack and pinion system, there must be several under-bar insertion instruments (one at neutral angulation and one at an accentuated angle at 1101, which fit the kyphosis lordosis of the treated level, to facilitate positioning.lIf necessary, it must be possible to transform the surgery from percutaneous to open using the same screws as the system. The system must be compatible with a retractor that, by pivoting the implanted screws making them uniaxial and taking advantage of a medial blade that can be angulated up to 27' and retraction up to 3cm, allows for easy decompression and cage placement.11 open system must be equipped with transverse connectors, bar-bar connectors, hooks, and extension systems from previous stabilizations without having to remove the existing construct.In the open system, the screws must be fixed screws, polyaxial with polyaxiality greater than SO°, uniplanar (also from reduction), fenestrated both mono and polyaxial, iliac also from reduction. Diameters should range, depending on the type of screws, from 4.0 mm to 10.5 mm (recognizable by color coding) and be a minimum of 25 to a maximum of 100 mm long. Straight bars should have a hexagonal end and a visual indication of lordosis. Ultrasound osteotome with dual 22.5-kHz universal handpiece.Disposable blades and shaver kits of various sizes and shapes. Tips available for minimally invasive access. Suction circuit. Tips must have internal irrigation channel New-generation bone substitutes, not previously on the market, in various types for arthrodesis and treatment of bone fractures.Synthetic bone substitute, ready in syringe for application, consisting of bioactive glass spheres in two sizes small and large and a reinsorbable phospholipid carrier (lecithin). Bone substitute - synthetic bone cement, ready in syringe for application, biocompatible, osteoconductive and bioresorbable based on plant raw materials and emulsifiers containing synthetic calcium and phosphate salts finely dispersed in a biocompatible oil phase of short-chain triglycerides and two emulsifiers, polyoxyl 35 castor oil and cetyl phosphate. Synthetic resorbable bone substitute in patches, designed for application on arthrodesis systems to ensure fast and efficient fusion, moldable and in high-strength flexible patch based onI3¬tricalcium phosphate(3-TCP) with added low-density porcine collagen in the moldable version, high-density in the flexible version. Available sizes: Bone substitute made of resorbable biphasic ceramic material designed for filling skull and spine bone defects, composed of 60% calcium phosphate and 40% (3-tricalcium phosphate. The ceramic structure must be totally interconnected with more than 80% porosity, biomimetic resistant and compact. Custom made, sterile and disposable cranioplasty system. The plate shall be bacteriostatic and promote bone growth due to the presence of embedded bioactive glass. Implantation is by titanium screws. The system shall be made of composite material consisting of a laminated structure of bioglass fibers, resin and bioglass particles. The bioglass particles are placed in the space between two layers of interwoven bioglass fibers. The system is designed and 3D printed following the details of the patient's tomodensitometric study Silver thoracolumbar vertebral fixation system with silver ion coating feature reduces the rate and risk of infection, decreases the patient's hospitalization period and avoids bacterial growth (MRSA) with a high level rate (91.6%) (methicillin-resistant staphylococcus aureus 11-in) fully programmable 32-channel intraoperative monitoring system so that no constraint is placed on the surgeon on the choice of myotomes and anatomical districts to be monitored. It must be guaranteed to monitor EMG, SEP, PEM as well as directional detection of nerve roots present in the operating field microsurgery goggles 6.0X, magnification: 6 times, depth of field: 4cm, field of view: 55mm Magnification: 6 X,. 1. magnification of the lens with high quality optical glass, plating multi-layer anti-reflective film, high transmittance, large image of the transparent field of view; 2. long working distance, clear and bright and wide field of view for a variety of fine surgery to provide convenient use; 3. unique upper and lower position to adjust the structure of human design, to meet the individual needs of doctors; 4. adjust the interpupillary distance can be adapted to a variety of face shapes. PRO Structure of surgical headlamp: from the lamp, stand, power box, charger and other components. Long life, no need to replace the bulb, convenient, small size, the lamp is only 30 grams custom pack for neurosurgery as follows: No. 1 Absorbent/waterproof double-lined TNT mother table cover 150x200; No. 4 Absorbent placemats 40x40; No. 2 SMS Reinforced Scrubs size XL; No. 1 T-shaped Lumbosacral Monotelo cm. 260x320x200 cm fenestration 10x30 with etching film covered with absorbent reinforcement equipped with Velcro 150x200 tube fixator equipped with 3 compartment instrument pocket (positioned at one); No. 1 Polyethylene Mayo table bag drape with reinforced area cm 80x150; No. 1 TNT triacoupled drape cm 250x300 with oval hole cm 20x30 equipped with film from No. 2 Suture holder pockets;No. 4 TNT adhesive strips cm 10x50; No. 1 Tri-coupled TNT drape cm 250x300 with oval hole cm 20x30 equipped with incision film and fluid collection pouch Trabeculated titanium spheres of about 4mm diameter, made by electron beam fusion additive technology, used to fill any bone cavity due to the osteoinductive capacity of trabeculated titanium and high mechanical strength. The system can be enriched with bone marrow concentrate taken by means of special trocars and centrifuged in tubes with appropriate separating gel or with growth factors to accelerate the osseointegration process custom-made titanium cranioplasties (Custom made) made by Electron Beam Melting (EBM) technology, which allows obtaining preps with excellent mechano- and osseointegrating properties. Enriched with kits for the production of bone marrow concentrate and growth factors on bone substitute carriers in paste and granules that accelerate the process of osteointegration essential for the long-term survival of the implant.Possibility of making an anatomical site in ABS plastic polymer that can be sterilized in a glove-cycle autoclave. The custom-made garment is derived through an initial design phase, 3D engineering from CT, and later, produced by 3D printing from gade 5 titanium alloy (Ti6Al4V) powders with additive technology (Additive manufactoring). This technology ensures high precision in shape and adherence to contours; excellent biointegrative properties; low weight and thickness of 1 mm; compatibility with CT, MRI,RX; removable pre-cut lines via grooves; 0.3-mm fixation fins configurable in hole placement and size or with perimeter multi-punched edge along the contour of the prosthesis; multi-hole structure for easy suspension to the dura (10 holes per cm2); high mechanical resistance to any kind of stress; porous structure for optimal osseointegration and improved adhesion with the subcutis. In addition, no intraoperative adaptation modification (milling or metal cutting) is required

Opportunity closing date

11 December 2023

Value of contract

£5m-50m