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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

According to the authors, these findings suggest that FloStent could serve as an effective interim solution for men who are awaiting TURP.

FloStent device shows efficacy for acute urinary retention due to BPH

The phase 2 trial has shown encouraging safety and efficacy results for carotuximab and apalutamide in patients with mCRPC.

Carotuximab plus apalutamide demonstrates promising PFS in mCRPC

Kanika Searvance, MD, and Yasin Bhanji, MD, discuss the evolution of BPH care. 

Optimizing BPH care: Experts discuss HoLEP, MISTs, and shared decision-making

Both the Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath and the Dornier Axis II Slim single-use ureteroscope are FDA-cleared.

Dornier single-use ureteroscope and ureteral access sheath launch on US market

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Khurshid R. Ghani, MBChB, MS, FRCS, discusses how results from the SOUL trial may shape clinical decision-making regarding stent placement.

Khurshid Ghani, MBChB, MS, FRCS, on current barriers to stent omission 

The SOUL study is assessing patient-reported outcomes and unplanned health care utilization among patients who had stent placement vs stent omission after ureteroscopy.

Khurshid Ghani, MD, on trial of stent omission following ureteroscopy

In these videos, high-volume stone surgeons demonstrate novel approaches to classification, visualization, and treatment of stones.

Ureteroscopy: Surgeons show techniques, tips in videos

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric patients 12 years and older with uncomplicated gonorrhea, Innoviva Specialty Therapeutics announced in a news release.

The Prescription Drug User Fee Act (PDUFA) target action date for the application is December 15, 2025.

Zoliflodacin is an oral antibiotic that inhibits type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. According to the company, “If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.”

The FDA has also granted a Qualified Infectious Disease Product designation to zoliflodacin, which enables the agent to benefit from priority review and market exclusivity.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, in the news release.

 “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

The NDA for zoliflodacin is supported by data from several clinical trials conducted through a collaboration with the Global Antibiotic Research & Development Partnership (GARDP). This portfolio of studies includes a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm, representing a difference of 5.3% (95% CI, 1.4% to 8.7%) across patients in the micro-intent-to-treat (ITT) population.

The 2 cohorts also demonstrated comparable results on the trial’s secondary end point of microbiological response at extragenital (rectal or pharyngeal) sites. Specifically, at pharyngeal sites, the cure rate was 79.2% in the zoliflodacin arm vs 78.6% in the ceftriaxone/azithromycin arm (difference, -0.67%; 95% CI, -20.8 to 16.3). At rectal sites, the cure rate was 87.3% and 88.6%, respectively (difference, 1.23%; 95% CI, -14.4 to 12.6).

Zoliflodacin was generally well-tolerated in the trial. Treatment-emergent adverse events (TEAEs) occurred in 46.2% of patients in the zoliflodacin arm vs 46.4% of patients in the ceftriaxone/azithromycin arm. The most common TEAEs in the zoliflodacin arm included headache (9.9%), neutropenia (6.8%), and leukopenia (3.9%).

There were no deaths or serious adverse events reported in either arm.

In total, the phase 3 trial included 930 patients with uncomplicated gonorrhea, including patients living with HIV. The study enrolled participants across 16 clinical trial sites in the US, Belgium, the Netherlands, South Africa, and Thailand.

According to Innoviva, the phase 3 study was “the largest clinical trial ever conducted for a new treatment against gonorrhea infection.”

Those enrolled in the study were randomly assigned 2:1 to receive 3 g single-dose, oral zoliflodacin (n = 621) or to 500 mg ceftriaxone intramuscular plus 1g oral azithromycin (n = 309). The primary end point was microbiological cure by culture at urogenital sites in the micro-ITT populations, with a non-inferiority margin of 12%. The trial’s secondary end point was microbiological cure at extragenital sites.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Manica Balasegaram, Executive Director of GARDP, in the news release.

 “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

1. Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. News release. Innoviva Specialty Therapeutics. Published online and accessed June 10, 2025. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/

2. FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. Published online and accessed June 12, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025 

3. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf

The FDA has accepted the NDA for zoliflodacin, a novel oral antibiotic for treating uncomplicated gonorrhea in patients aged 12 and older. Zoliflodacin, which inhibits type II topoisomerase, has been granted a Qualified Infectious Disease Product designation, allowing for priority review. Clinical trials, including a pivotal phase 3 study, demonstrated that zoliflodacin is non-inferior to the standard regimen of ceftriaxone and azithromycin. The trials showed comparable microbiological cure rates at urogenital and extragenital sites, with zoliflodacin being generally well-tolerated and no serious adverse events reported.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea. 

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

FDA accepts BLA for subcutaneous nivolumab in solid tumors

“Don’t judge each day by the harvest you reap but by the seeds you plant.” — Robert Louis Stevenson

As a practicing urologist and department chair who has trained several hundreds of students, residents, and fellows, I see daily evidence of a mounting crisis in our specialty. Our clinics are overflowing, surgical block times are often limited, and patients in rural areas of our states often drive several hours for even routine care. More concerning is the access to high-quality, patient-centered, research-driven, multidisciplinary care for those with disparities that place them at the highest risk for poor outcomes due to delay in diagnosis or limited access to care. These stories are not outliers—they reflect a systemic imbalance between supply and demand that is well documented in recent analyses from RAND,

 the Association of American Medical Colleges (AAMC),

 the Health Resources and Services Administration (HRSA),

 and the American Urological Association (AUA).

 Together, these data leave us with both a sobering diagnosis and a mandate for action.

A More Sophisticated Look at Physician Manpower

The 2025 RAND-AAMC system-dynamics model represents a major step forward in how we understand physician manpower. Unlike static ratio-based models, RAND’s approach accounts for workforce inflows and outflows—medical school expansion, graduate medical education bottlenecks, retirements, advanced practice providers (APPs), integration, and system inefficiencies.

The implications for surgical specialties are alarming. By 2036, AAMC projects a shortfall of 10,100–19,900 surgeons.

 HRSA’s 2024 workforce report estimates urology will fall to just 82% adequacy by 2037—an 18% gap.

 And, although thoracic and vascular surgery face similar or worse shortages, the burden in urology is uniquely concerning given the age-driven rise in incidence of diseases such as prostate cancer, stone disease, benign prostatic hyperplasia, and incontinence. Without intervention, our specialty risks being unable to meet even baseline patient needs.

The AUA Census adds vital granularity, confirming what many of us already feel in clinic:

• Geographic maldistribution: 62% of U.S. counties have no practicing urologist.

• Aging workforce: Nearly 20% of urologists are over age 65, with many nearing retirement.

• Reliance on APPs: 84% of practices employ nurse practitioners or physician assistants, who increasingly shoulder outpatient and perioperative responsibilities.

• Heavy workload: Urologists average approximately 45 hours and 70 patient encounters per week, with the majority performing major inpatient operations.

These data align with the lived reality of our clinics and operating rooms: too few providers, too many patients, and growing dependence on collaborative care models.

For practicing urologists, the message is clear: Unless we expand the pipeline, improve efficiency, and retain talent, our already stretched workforce will be overwhelmed. For our APP colleagues, the Census confirms what many of us already know: Your role is not supplementary, but central to the care delivery now and going forward. The future of urology depends on APPs managing much of the perioperative, urgent, and routine care that keeps practices viable and surgeons focused where they are most needed.

So how do we respond? The RAND model points to leverage points; the AUA Census shows us where gaps already exist. The following strategies are both pragmatic and necessary:

 Increase GME positions in urology, with deliberate placement in rural and underserved areas where retention is most likely. Fellowship growth should reflect projected need in oncology, endourology, pediatrics, and reconstruction. The implementation and economics of this are complex, with multiple competing specialties and the need for approval at the national and local level, followed by complexity of securing the necessary funding that will inevitably come from private and local/state funding.

 Federal and philanthropic support should ease medical school debt and expand opportunities for expansion with diverse groups. Diversity in urology is improving but fragile; it will require mentoring and institutional commitment to sustain.

 Establish structured clinical and perioperative fellowships along with career ladders for APPs. With 84% of practices already employing APPs, formalized training and role definition will expand access while ensuring quality. Early exposure to urology in their core curriculums will also be needed to attract more candidates to the field. This is also a great opportunity for us a field to more formally impact the quality of their training in our subspecialty field.

 The shortage is not simply one of headcount. Operative bottlenecks, imaging delays, and inefficient scheduling all reduce effective capacity. Expanding ambulatory surgery centers, leveraging telehealth triage, and rethinking block allocation can extend the reach of existing providers. Undoubtedly, use of artificial intelligence particularly to improve office efficiencies, and documentation will be welcomed and could aid in preventing provider burnout.

 Retirement and burnout are imminent threats. Creating flexible call schedules, phased retirement pathways, and administrative support can help us keep experienced urologists engaged and productive longer. We need to continue to keep up with the changing landscape of our field, and continuing medical education and continuous urologic certification will be key to ensuring safe and quality care to our patients. On that note, urologists contemplating a transition toward retirement, they may want to rethink their retirement runway and extend their American Board of Urology certification in the event that they delay retirement or reenter the workforce after only a short exit from the workforce as they reenter in a different practice arrangement.

As urologists, we pride ourselves on being problem solvers. Yet the workforce crisis is one we cannot solve in the clinic alone. It requires coordinated advocacy at both the local and national level, institutional vision, and leadership from those of us who have benefitted most from this specialty. Creativity and partnerships with public and private health care institutions may provide new pipelines for providers and new opportunities in underserved and rural areas.

I urge my colleagues to act with urgency: Advocate for GME expansion, redesign team-based models, mentor the next generation, and empower APPs to work at the top of their license. As urologists, we should be proactive and creative as we find new ways to attract, retain and train the next generation. As department chairs and leaders, we must balance tradition with innovation, preserving the core of urologic surgical training while adapting to new realities.

The alternative—longer waits, fewer urologists, and diminished access for our patients (and someday for ourselves)—is unacceptable. The patient waiting months for a prostatectomy or cystectomy, or traveling hundreds of miles for stone surgery, the family delayed in starting cancer care with the potential negative impact on outcome—they are why we must lead this change.

Urology has always been a field defined by adaptability and ingenuity. Meeting this challenge will require both, and it will require us to act now.

1. Tomoaia-Cotisel A, Allen SD, Cave S, et al. Modeling physician workforce supply, demand, and need using system dynamics: model structure and assumptions. RAND Corporation. March 5, 2025. Accessed September 3, 2025. https://www.rand.org/pubs/research_reports/RRA2616-1.html

2. Association of American Medical Colleges. The Complexities of Physician Supply and Demand: Projections From 2021 to 2036. 2024 update. Accessed September 3, 2025. https://www.aamc.org/media/75236/download

3. Health Resources & Services Administration. Physician Workforce: Projections, 2022–2037. Accessed September 3, 2025. https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/physicians-projections-factsheet.pdf

4. Adashi EY, O'Mahony DP, Gruppuso PA. The National Physician Shortage: Disconcerting HRSA and AAMC Reports. J Gen Intern Med. 2025 May 6. doi: 10.1007/s11606-025-09575-7. PMID: 40329027

5. American Urological Association. 2024 AUA Census Results. Accessed September 3, 2025. https://www.auanet.org/research-and-data/aua-census/census-results

"As urologists, we should be proactive and creative as we find new ways to attract, retain and train the next generation," writes Michael S. Cookson, MD, MMHC, FACS.

Navigating the urology workforce crisis: A call to action

Two-year outcomes from the ASPIRE trial continued to show that steerable ureteroscopic renal evacuation (SURE) with the CVAC Aspiration System led to significantly reduced health care consumption events (HCEs) compared with ureteroscopy (URS).

The updated findings were shared during the 2025 World Congress of Endourology and Uro-Technology (WCET), building on 1-year data that were previously presented 2024 annual meeting.

“The data presented at WCET 2025 reinforce what many of us are seeing in practice—the second-generation CVAC System is a reliable, effective, and differentiated solution for stone clearance,” said Karen Stern, MD, an associate professor of urology at the Mayo Clinic College of Medicine and Endourology Fellowship Program Director in Arizona, in a news release on the findings.

In total, the study enrolled 101 adult patients across 11 clinical trial sites in the US. All patients had at least 1 renal stone and total stone burden of 7 to 20 mm. For the study, participants were randomly assigned to undergo the SURE procedure (n = 46) or URS (n = 55). HCEs were defined as emergency department visits, hospitalizations, and retreatment.

At 2-year follow-up, 4.3% of patients in the SURE arm vs 20% of patients in the URS arm experienced a HCE (

 = .02), translating to a 73% reduction in the risk of HCE in the SURE arm. The index treatment remained a significant predictor of HCE even after adjusting for baseline stone volume (adjusted HR, 0.2, 95% CI, 0.04 to 0.90; 

 = .04). Overall, patients who underwent URS were 5 times more likely to experience a HCE compared with those who underwent the SURE procedure.

Further, patients who underwent the SURE procedure demonstrated a significantly longer event-free period vs those who underwent URS. Specifically, the average time to event was 701.6 days in the SURE arm compared with 608.2 days in the URS arm, yielding a mean difference of 93.4 days.

Safety was found to be comparable through 2-year follow-up.

Overall, the authors conclude that these findings link the CVAC system’s mechanism of action to long-term benefits in patients with kidney stones.

Data from the prospective CLEARANCE study, evaluating the safety and efficacy of the CVAC System, were also presented at the 2025 WCET meeting. Overall, results showed that CVAC was safe and led to high stone clearance and low residual stone volume (RSV) in patients with kidney stones. The data were presented by Brian Eisner, MD, who is the chair of urology at Tulane University School of Medicine in New Orleans, Louisiana.

In total, the study included 30 patients who were treated across 10 surgeons. Of those, 26 patients had non-contrast CT available at post-operative day 30. At baseline, the mean stone volume and density was 703.6 mm

Data showed that the mean stone clearance increased from 93.8% on day 1 to 96.2% on day 30. Over the same time period, RSV decreased from 36.0mm

The authors noted, “Stone clearance remained high, and RSV remained low at [post-operative day] 30 even with increasing baseline stone volume.”

Additionally, the stone-free rate (no residual stones) increased from 25% on post-operative day 1 to 46.4% by post-operative day 30.

No device-related injuries were reported. All adverse events were mild and resolved without issues. No patients in the study required retreatment or hospital readmission for residual fragments.

“The CLEARANCE study presented by Brian Eisner, MD, reinforces the consistency of outcomes we've seen across trials—even in more complex cases with higher-density stones,” Stern added in the news release.

 “This is particularly meaningful given the ASPIRE 2-year findings identified residual stone volume as the strongest predictor of long-term health care consumption events. This is the first and only study to track long-term outcomes of an aspiration procedure, which showed that patients treated with SURE using the CVAC System experienced significantly fewer unplanned post-op care events compared to those treated with traditional URS. As technologies evolve, adopting standardized volumetric metrics like RSV will be key to guiding care and ensuring lasting benefits for patients.”

1. Calyxo debuts reverse deflection CVAC System and reveals groundbreaking two-year ASPIRE data at WCET 2025, underscoring the technology’s role in advancing endourology. News release. Calyxo. September 11, 2025. Accessed September 11, 2025. https://www.businesswire.com/news/home/20250911893155/en/Calyxo-Debuts-Reverse-Deflection-CVAC-System-and-Reveals-Groundbreaking-Two-Year-ASPIRE-Data-at-WCET-2025-Underscoring-the-Technologys-Role-in-Advancing-Endourology

2. Stern K, Matlaga B, Mueller T, et al. Steerable Ureteroscopic Renal Evacuation Reduces the Risk of Healthcare Consumption Events at 2 Years Compared to Standard Ureteroscopy (URS). Presented at: 42nd World Congress of Endourology and Uro-Technology (WCET). Phoenix, Arizona. Abstract MP16:01. https://www.liebertpub.com/doi/10.1177/08927790251368714

The ASPIRE trial demonstrated that steerable ureteroscopic renal evacuation (SURE) with the CVAC Aspiration System significantly reduced healthcare consumption events (HCEs) compared to traditional ureteroscopy (URS) over two years. The study involved 101 patients, showing a 73% reduction in HCE risk for SURE. The CLEARANCE study further confirmed the CVAC System's safety and efficacy, with high stone clearance and low residual stone volume. These findings highlight the CVAC System's potential for long-term benefits in kidney stone management, emphasizing the importance of standardized volumetric metrics like residual stone volume.

Two-year outcomes from the ASPIRE trial continued to show that the SURE procedure led to significantly reduced health care consumption events compared with ureteroscopy.  

Khurshid R. Ghani, MD

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