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. Possible complications include, but may not be limited to perforation, puncture, bleeding, and/or hematuria, damage to ureter or kidney, discomfort, pain, inflammation, infection, and/or fever and ureteral avulsion. Decisions about patient care depend on the physician’s professional judgment after considering all available information.
Case photos, videos, and physician descriptions are not representative of all clinical outcomes and individual results will vary.
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 IFU at www.calyxoinc.com/IFU
Clinical References
- Sur RL et al., J Endourol. 2022 Sep;36(9):1161-1167. Initial Safety and Feasibility of Steerable Ureteroscopic Renal Evacuation: A Novel Approach for the Treatment of Urolithiasis. https://pubmed.ncbi.nlm.nih.gov/35331002/
- Stern KL et al., J Endourol. 2023 Aug 28;37(11):1179–83. Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study. https://pubmed.ncbi.nlm.nih.gov/37639362/
- Chi T et al., J Endourol. Sep 2023, Vol 37, Supplement 1. Steerable Ureteroscopic Renal Evaluation Achieves Higher Stone Clearance and Lower Residual Stone Volume Compared to Ureteroscopy with Basketing. https://www.liebertpub.com/doi/10.1089/end.2023.36001.abstracts
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