The CVAC Aspiration System is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
Contraindications for the CVAC Aspiration System are the same as those specific to ureteroscopy. Diagnostic or therapeutic ureteroscopy is contraindicated in patients with untreated urinary tract infection. Patients with coagulation disorders, severe cardiopulmonary insufficiency, or uncontrolled diabetes should be managed appropriately.
Calyxo, Inc. does not promote or encourage the use of its devices outside their approved labeling.
As with any medical treatment, there are some risks involved with the use of the CVAC Aspiration System. Complications include but may not be limited to perforation, puncture, bleeding, and/or hematuria, damage to ureter or kidney, discomfort, pain, inflammation, infection, fever, ureteral avulsion, and additional intervention required. Some complications may require intervention and may lead to a serious outcome. Decisions about patient care depend on the physician’s professional judgment after considering all available information.
Individual results will vary. Case photos, videos, and physician descriptions are not representative of all clinical outcomes.
Caution: U.S. Federal law restricts this device to use on the order of a physician. For complete product information, including indications, contraindications, warnings, precautions, and adverse events, see product instructions for use at: www.calyxoinc.com/IFU
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