Clinical Evidence

Superior Stone Clearance, Supported by Level 1 Evidence

ASPIRE Study: Multi-center, Prospective, Randomized Controlled Trial

KEY FINDINGS

SURE was statistically superior to standard URS in efficacy, achieving high mean stone clearance of 97% and consistently low residual stone volume.
CVAC System maintained its efficacy independent of the baseline stone burden, while the efficacy of standard URS decreased with increasing baseline stone burden.
No difference in safety between the two groups.

Seeing Is Believing

Without CVAC System:

Residual kidney stone fragments remain after laser lithotripsy.

With CVAC System:

Irrigation and aspiration are used to vacuum residual fragments during and after laser lithotripsy, enabling complete stone clearance.

Additional Publications

Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study

Stern, K et al, 2023, Journal of Endourology

KEY FINDINGS

CVAC is a safe and effective procedure for large stone burdens and may be used for high-risk patients.
It drastically reduces stone volume regardless of baseline stone burden.
It can decrease the need for secondary procedures.
CVAC should be considered to avoid the morbidity from repeat ureteroscopy or PCNL.

Initial Safety and Feasibility of Steerable Ureteroscopic Renal Evacuation: A Novel Approach for the Treatment of Urolithiasis

Sur, R et al, 2022, Journal of Endourology

KEY FINDINGS

This initial study suggests SURE is safe, feasible, and may be more effective in stone removal postlaser lithotripsy compared to basketing.
SURE removed a significantly greater stone volume and significantly greater proportion of total stone volume at day 1 when compared with basket extraction.
The higher proportion of stone volume removed led to a 100% SFR as measured by CT at 30 days for SURE vs 75% for Basket.

MAC00074.B