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CVAC Aspiration System achieves 96% stone clearance in small renal stone evacuation studyNew kidney stone removal system shows high clearance rate in small study

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Key Takeaway
Consider early data showing high stone clearance but a 46% stone-free rate with the CVAC system in a small, uncontrolled study.

This prospective, single-arm study evaluated the safety and effectiveness of the second-generation CVAC Aspiration System for steerable ureteroscopic renal evacuation in 30 subjects with renal stones. Of the enrolled subjects, 26 had evaluable noncontrast CT (NCCT) data at postoperative day 30. The mean baseline stone volume was 703.6 mm³, and mean stone density was 1203 HU.

The primary outcomes were stone clearance, residual stone volume (RSV), and stone-free rate (SFR). The mean stone clearance was 96.2%, and the average RSV was 14.1 mm³. The SFR, defined as zero residual fragments, was 46.4%. The study reported that stone clearance remained high and RSV remained low even with increasing baseline stone volume.

Regarding safety, there were two instances of urinary tract infection (Clavien-Dindo grade II). No subjects required intervention or retreatment. Key limitations include the single-arm design without a comparator, the absence of 4 subjects from the POD 30 analysis, and a strict definition of stone-free status. The practice relevance is limited as this is an early, uncontrolled evaluation of a specific device.

Researchers tested a new medical device called the second-generation CVAC® Aspiration System for removing kidney stones. The study included 30 patients with kidney stones, though only 26 had complete follow-up data at 30 days after the procedure. The device uses a steerable tube inserted through the urinary tract to vacuum out stones.

The main finding was that the system removed an average of 96% of the stone volume. However, when looking at whether patients had zero stone fragments left, only 46% met this strict definition of 'stone-free.' The average leftover stone volume was very small. Two patients developed urinary tract infections after the procedure, but no one needed additional treatment or another procedure.

It's important to be careful with these results because this was a small study with no comparison group. We don't know how this system compares to other stone removal methods. Also, four patients were missing follow-up data, which could affect the results. The study shows this device can remove most stone material, but whether it leads to better patient outcomes than existing options requires larger, comparative studies.

Readers should understand this is early research on a specific medical device. The results are promising for removing stone volume, but the 'stone-free' rate was lower than the clearance rate. Patients with kidney stones should discuss all available treatment options with their urologist.

What this means for you:
Early study shows new kidney stone device removes most stone material, but more research is needed to compare it to other treatments.

Study Details

EvidenceLevel 5
PublishedApr 2026
View Original Abstract ↓
PURPOSE: To evaluate the safety and effectiveness of the second-generation CVAC® Aspiration System. METHODS: A prospective study of steerable ureteroscopic renal evacuation using the second-generation CVAC was performed. Stone clearance (percent stone volume removed), residual stone volume (RSV), and stone-free rate (SFR) at postoperative day 30 were assessed using noncontrast CT (NCCT). Adverse events were recorded. RESULTS: Twenty-six out of 30 subjects had POD 30 NCCT. Mean baseline stone volume and density were 703.6 mm and 1203 HU, respectively. Mean stone clearance was 96.2%; average RSV was 14.1 mm, and SFR (zero residual fragments) was 46.4%. Stone clearance remained high, and RSV remained low with increasing baseline stone volume. There were two instances of urinary tract infection (Clavien-Dindo grade II) and no subjects requiring intervention or retreatment. CONCLUSIONS: The CVAC Aspiration System safely delivers high stone clearance and low RSV.
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