Thulium laser Elyra™

lithotripsyholmiumHo:YAG

Overview
The Elyra™ Thulium Fiber Laser (TFL) System advances urinary stone lithotripsy and soft tissue urologic procedures by offering high procedural efficiency, fine dusting capability and streamlined OR integration. TFL technology provides clinical advantages over traditional Holmium:YAG systems in select indications while supporting typical operating-room power requirements.

Key benefits

• Effective stone dusting — TFL delivers improved stone dusting performance and procedural efficiency in lithotripsy compared with Ho:YAG in reported studies.
• Reduced stone migration — Clinical evidence indicates lower stone migration rates during treatment of urolithiasis with TFL versus Ho:YAG.
• Quieter operation — Air‑cooled design reduces system noise, improving OR environment.
• Standard power compatibility — Operates from standard power outlets, simplifying installation and integration.

Features and design
The Elyra™ TFL System is engineered for clinical workflow and user ergonomics. Notable elements include an intuitive user interface with customizable presets, rapid start-up, optional wireless footswitch where supported, effective hemostasis capability, integrated accessory storage, broad compatibility with BD single‑use Elyra™ Thulium Laser Fibers, and safety features such as anatomical power notifications. The air‑cooled architecture limits operational noise and supports flexible OR placement.

Product configurations and compatibility
Two primary configurations are offered: Elyra™ TFL System and Elyra™ Plus TFL System, both within BD's Stone Management portfolio. The Elyra™ Plus configuration may enable additional functionality in certain markets or configurations. The system accepts a wide range of single‑use Elyra™ Thulium Laser Fibers in multiple core sizes and tip styles.

Available fibers / delivery options

• Single‑use Thulium Laser Fibers — 150 μm (ball tip and standard tip)
• Single‑use Thulium Laser Fibers — 200 μm (ball tip and standard tip)
• Single‑use Thulium Laser Fibers — 272 μm (ball tip and standard tip)
• Single‑use Thulium Laser Fibers — 365 μm (standard tip)
• Single‑use Thulium Laser Fibers — 550 μm (standard tip)
• Single‑use Thulium Laser Fibers — 940 μm (standard tip)

Indications for use
The Elyra™ and Elyra™ Plus TFL Systems (laser, fibers, and accessories) are intended for incision, excision, resection, ablation, coagulation and hemostasis of soft tissue, with or without an endoscope, in urology and for lithotripsy. Specific urology indications include treatment of condylomas, urethral strictures, lesions of external genitalia, bladder neck incisions, ablation and resection of bladder/urethral/ureteral tumors, endoscopic fragmentation of urinary calculi and treatment of distal impacted fragments in the ureters following lithotripsy. Lithotripsy indications include endoscopic fragmentation of calculi of various compositions (including cystine and calcium oxalate) and treatment of distal impacted fragments of steinstrasse when guidewire passage is not possible. The Elyra™ Plus configuration is additionally indicated for vaporization of soft tissue in specified urology procedures including BPH-related resection, enucleation and ablation, and transurethral incision of the prostate where indicated.

Contraindications and cautions

• Not intended for patients for whom endoscopic procedures are contraindicated or for whom general medical condition contraindicates surgical intervention or anesthesia.
• Not for patients with septic peritonitis, septic shock, or for procedures in patients diagnosed with prostate cancer where contraindicated.
• Not intended for resection/excision of large highly vascularized organs or calcified tissue (notably some tumors) or when access is severely limited (e.g., skeletal/renal anomalies, pleural interposition).
• General urology contraindications include acute bleeding propensity, anticoagulation therapy, hemostasis of vessels >2 mm diameter and untreated urinary tract infections.

Important safety information (summary)
Improper use or damaged components may cause severe eye, skin or tissue injury, accidental laser exposure, thermal injury or burns, fire hazards in the OR, or system damage. The device emits Class 4 laser radiation when in use and must be operated only by physicians trained in laser surgery. Start at the lowest effective laser setting, use continuous irrigation to mitigate thermal risk, and verify correct laser safety eyewear for staff and patient. Only set the system to READY when the delivery fiber is at the intended treatment site with at least 8 mm of fiber extending beyond the scope. Inspect fibers for damage and aiming beam circularity prior to use. Laser plume may contain hazardous constituents; use appropriate evacuation and PPE. Laser energy can damage guidewires or baskets; take precautions to avoid secondary tissue injury. See the Elyra™/Elyra™ Plus user manual for full warnings, precautions and instructions.

Clinical references and notes
Selected references on the product page include meta‑analyses and comparative studies of Thulium Fiber Laser versus Holmium:YAG for ureteroscopic lithotripsy, ex vivo soft tissue comparisons, and OR noise assessments that report relative advantages of TFL. Some claims cite preclinical research; specifications and clinical performance are subject to change.

Technical characteristics / specifications

• Product family: Elyra™ Thulium Fiber Laser System (Elyra™ and Elyra™ Plus configurations).
• Intended uses: incision, excision, resection, ablation, coagulation and hemostasis of soft tissue; endoscopic fragmentation of urinary calculi.
• Fiber compatibility: broad range of single‑use Elyra™ Thulium Laser Fibers (multiple core sizes and tip styles as listed above).
• Power requirements: compatible with standard power outlets (no specialty outlet required).
• Cooling: air‑cooled design (reduced operational noise versus some Ho:YAG systems).
• User interface: customizable presets, rapid start-up, optional wireless footswitch depending on configuration.
• Safety features: anatomical power notifications and integrated safety‑focused design elements; device emits Class 4 laser radiation in use.
• Accessories: integrated storage for accessories, cords and footswitch.
• Regulatory / labeling notes: specifications subject to change; refer to Instructions for Use and user manual for full specifications and safety information.