Boston Scientific accounts are for healthcare professionals only.
Thuvera™ Laser System
IFU #MD2600F-001956 Rev. D
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
Only licensed professionals who have reviewed and understood this User Manual should use this device. Physicians must use their own clinical judgment and professionalism in determining all aspects of treatment, technique, proper power settings, interval, duration, etc.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
INTENDED USE AND INDICATIONS
The Thuvera Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy.
Urology:
- Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- Laser Resection of the Prostate (LRP)
- Laser Enucleation of the Prostate (LEP)
- Laser Ablation of the Prostate (LAP)
- Transurethral Incision of the Prostate (TUIP)
- Bladder neck incisions (BNI)
- Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
Lithotripsy and Percutaneous Urinary Lithotripsy:
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate deihydrate stones
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
CONTRAINDICATIONS
The use of the laser system consistent with the indication for use in this IFU are at the discretion of the physician except in cases where the following conditions are specifically contraindicated:
- Inability to receive endoscopic or laparoscopic treatment
- Intolerance to anesthesia
- Resection or excision of large, highly vascularized organs
- Carcinoma of the prostate
- Septic peritonitis
- Intestinal obstruction
- Septic shock
- Patients under the age of 18 years old
WARNINGS
Doctor, patient, assistant and all others inside or entering the operating room must wear appropriate laser protection eyewear for the 1940nm wavelength, OD (3) or greater whenever the laser is in user. Prior to use, inspect eyewear for pitting and/or cracking. Do not use if damaged.
POTENTIAL ADVERSE EVENTS
The following are possible risks of laser treatment. Please refer to Operation section of the IFU [Thuvera System IFU], the Thuvera Surgical Fiber IFU, and appropriate medical literature for additional details.
- Mild mucosal injury
- Transient urinary incontinence
- Urinary tract infection
- Post-operative bleeding
- Transient urethral stricture
- Fever
- Clot retention
- Bladder neck sclerosis