Belgium – Medical equipments – Purchase, installation and commissioning of a laser including the purchase of reusable fibers for the urology department

Opportunity description

The urology department wishes to acquire a single laser platform enabling the management of all urological indications currently performed at Sankt Nikolaus-Hospital (SNH), including: • laser prostate enucleation; • ureteroscopy for the treatment of urinary stones; • cystolithotripsy. Given the diversity of the clinical indications covered, the contracting authority has defined a set of minimum functional requirements directly related to the quality and safety of the care provided to patients. Following the market analysis and the trials conducted within the urology department, it appears that only the Quanta Cyber Ho Magneto™ system distributed by Tobrix BV simultaneously meets all the characteristics considered indispensable. The end users identified the following functionalities as essential in particular: • a double-pulse technology reducing stone retropulsion and facilitating enucleation; • an extended-pulse technology enabling the treatment of stones at a distance with minimal retropulsion; • a long-pulse technology improving coagulation performance. These functionalities correspond to the exclusive technologies: • Virtual Basket™; • Vapor Tunnel™; • Bubble Blast™; integrated into the Cyber Ho Magneto™. The contracting authority has not identified any other system simultaneously combining these different functionalities within a single Holmium laser platform. The users considered the ability to achieve pulse durations of up to 2.000 µs indispensable in order to obtain: • finer stone fragmentation; • a significant reduction in retropulsion; • improved coagulation capabilities. This characteristic is an essential element for ensuring the desired versatility between stone surgery and prostate surgery. The Cyber Ho Magneto™ allows peak power to be adjusted from 500 W to 10.000 W. This range enables: • dusting with low retropulsion; • fragmentation of large or very hard stones; • popcorning; • HoLEP; • complex percutaneous procedures. The system allows the pulse duration to be adjusted across seven levels covering a range between 50 µs and 2.000 µs. This customization capability is a clinical prerequisite enabling the parameters to be precisely adapted to the indications encountered. The Quanta Cyber Ho Magneto™ system allows the use of reusable laser fibers compatible with all the device’s operating modes. This characteristic offers several advantages: • reduction in the quantity of medical waste; • reduction in the cost of consumables; • simplification of logistics management. The reusable fibers offered also have a particularly competitive unit cost. Reduction in supplementary consumables Thanks to the significant reduction in retropulsion and the quality of dusting achieved by Magneto™ mode, procedures potentially require fewer auxiliary devices such as: • extraction baskets; • fragment retrieval accessories. This reduction helps lower the overall cost of procedures. SNH currently has a fleet of urological and gynecological endoscopy equipment largely composed of Karl Storz equipment. Replacing this fleet with equipment from another manufacturer would entail: • compatibility risks with existing optics; • compatibility risks with the irrigation and resection systems already in service; • the gradual acquisition of additional adapters and accessories; • indirect training and maintenance costs. The offer combining the Quanta Cyber Ho Magneto™ laser and RZ Medizintechnik instruments distributed by Tobrix BV instead makes it possible: • to maintain compatibility with the existing Karl Storz equipment; • to ensure uniformity of the instrument fleet; • to reduce the total cost of ownership over the equipment’s service life; • to continue gradually renewing the fleet according to the strategy defined by the department. The trials conducted within the urology department confirmed: • the system’s excellent effectiveness in treating urinary stones; • its performance in prostate surgery; • its hemostatic quality; • its versatility for the various targeted clinical indications. The users also noted an additional organizational advantage related to the significantly lower noise level of the ventilation system, improving working conditions in the operating room during prolonged procedures. In view of: • the clinical requirements defined by the end users; • the need to have a single platform covering all the urological indications concerned; • the exclusive technologies integrated into the Cyber Ho Magneto™; • the observed absence of competing equipment simultaneously combining all the required functional characteristics; • the requirements for compatibility with the existing instrument fleet; • the environmental and medico-economic considerations related to the use of reusable fibers; Following its market analysis and the demonstrations conducted, the contracting authority has not identified any other system capable of simultaneously satisfying all the functional, clinical, economic, and compatibility requirements set out above. In these circumstances, the conditions for the exception based on the absence of competition for technical reasons appear to be met, as no reasonable substitute or equivalent alternative solution was identified during the preliminary market analysis. Laser for the urology department Procedure: neg-wo-call. Review the original TED notice for the complete requirement, lots, amendments and attachments.