Clinical Evidence
The data behind balloon-free catheterization
Peer-reviewed outcomes, clinical outcomes comparisons, and independent research, consolidated for value analysis committees, clinical review boards, and procurement teams.
At a Glance
Four things to know
0%
CAUTI Incidence
Zero catheter-associated UTIs observed in a prospective 50-patient clinical trial. JAMA Internal Medicine observational data reported 5.7% diagnosed UTI and 10.5% composite infectious complications in catheterized patients.1,2
~4.8 mL
Residual Urine
Near-complete bladder emptying. The Foley balloon obstructs the drainage eye, pooling residual urine associated with bacterial colonization.1
57%
Foley Complication Rate
JAMA Internal Medicine: more than half of catheterized patients experience complications, with noninfectious complications 5× more common than infectious.2
0
Adoption Barriers
Same CPT code (51702), same insertion technique, same billing workflow. No new training, no new billing pathway, no formulary friction.
The Problem
Catheter complications extend far beyond what hospitals measure
A landmark JAMA Internal Medicine study followed 2,076 catheterized patients across 4 U.S. hospitals. The findings redefine what "catheter harm" means. Read the full study ↗
The problem is bigger than infection
Hospital safety programs focus almost exclusively on CAUTI. But noninfectious complications, including pain, bleeding, urgency, leaking, and skin trauma, affected 5 in every 9 catheterized patients. These are complications associated with balloon-based catheterization that surveillance systems miss entirely.2
Activity and dignity costs are invisible
Among patients still catheterized at follow-up, 39.5% reported restrictions in daily living and 43.9% reported social activity limitations. The study's authors described the indwelling catheter as a "one-point restraint," a burden current quality metrics do not capture.2
Growing malpractice exposure
A 50-year legal database review found that 48% of catheter-related malpractice claims involved traumatic insertion. Multiple lawsuits included spouse claims of loss of consortium. Balloon-based catheterization represents a growing liability exposure for facilities and care teams.10
Saint S, Trautner BW, Fowler KE, et al. JAMA Intern Med. 2018;178(8):1078-1085. doi:10.1001/jamainternmed.2018.2417
Downstream Impact
Catheter-associated UTI drives readmission and cost far beyond the index stay
An analysis of 2.5 million hospitalized UTI patients in the Premier Healthcare Database found that catheter-associated UTI carries the highest readmission burden of any UTI subtype, with skilled nursing facility patients at even greater risk.13
SNF patients face the highest readmission risk
Patients admitted from skilled nursing facilities with CA-UTI had the highest readmission rates of any UTI subgroup: 44% all-cause and 26% UTI-related within one year. This population also has the highest prevalence of long-dwell indwelling catheters, making it the setting most affected by the downstream costs of catheter-associated infection.13
CMS penalty exposure compounds with readmissions
Under the Hospital Readmissions Reduction Program, facilities face penalties up to 3% of Medicare reimbursement for excess readmissions. CMS separately penalizes bottom-quartile performers under the HAC Reduction Program. CA-UTI readmissions contribute to both penalty calculations, making catheter-associated infection a compounding financial liability.8
Judy BF, Kessler S, Gelman S, et al. Descriptive analysis of healthcare resource utilization and costs associated with treatment of urinary tract infections in United States hospitals. Am J Infect Control. 2022;50(2):190-198. doi:10.1016/j.ajic.2021.03.015
Clinical Proof
Prospective trial results
Prospective clinical trial data compared against published findings from JAMA Internal Medicine.
Peer-Reviewed · Published
The Lotus Catheter: A Non-Balloon Novel Urethral Catheter — A Prospective Study
50-patient prospective trial evaluating the Lotus catheter across multiple urological indications. Patients were assessed for CAUTI incidence, residual urine, pain, hematuria, and bladder spasms.
Read the full study
0%
CAUTI
~4.8 mL
Residual
0/10
Pain
0%
Hematuria
~2%
Spasms
~1 lb
Pull-Out Force
How to read this table. Lotus outcomes come from a prospective single-center clinical trial (N=50). Foley outcomes come from a multicenter observational study (N=2,076). The two studies use different designs, populations, and endpoints, so this is a range-of-published-outcomes comparison rather than a head-to-head clinical trial.
| Metric | Lotus Catheter™N=50 prospective study | Foley CatheterN=2,076 observational |
|---|---|---|
| Insertion & Removal | ~4 sec insertion · ~3 sec removal Single step, push to deploy, pull rod to retract. No syringe, no inflation, no separate supplies. N=50. 1 | Multi-step procedure Requires syringe for balloon inflation on insertion and deflation on removal. Incomplete deflation risks urethral trauma during extraction. 4 |
| Overall Complication Rate | 0% UTI · 0% hematuria · ~2% spasms Prospective clinical trial, N=50. 1 | 57% reported ≥1 complication Within 30 days. Noninfectious complications were 5× more common than infectious. N=2,076. 2 |
| Urinary Tract Infection | 0% UTI (0 of 50) Zero urinary tract infections detected across entire prospective cohort. N=50. 1 | 5.7% diagnosed UTI 5.7% told they had UTI; 10.5% reported any infectious complication (fever, chills, burning, urgency). N=2,076. 2 |
| Residual Urine | 4.8 mL mean PVR Near-complete drainage. Lumen rests at bladder neck. Prospective study, N=50. 1 | 77 mL mean PVR Vs. 0 mL for straight catheters. Balloon elevates lumen above pooled urine, preventing complete emptying and promoting bacterial colonization. 1 |
| Patient Discomfort | 0/10 insertion · 2/10 removal Wong-Baker scale. Mean insertion discomfort 0 (no pain). Mean removal discomfort 2/10. N=50. 1 | 54.5% reported pain Pain or discomfort with catheter in place, patient-reported (n=124 subgroup). 2 |
| Removal Complications | 0% trauma No gross hematuria at insertion. Two accidental dislodgements caused zero urethral injury, no hematuria. N=50 cohort. 1 | 30.9% removal complications Composite: pain, discomfort, bleeding, and/or trauma during removal. Separately, 10.0% reported blood in urine while catheterized. 2 |
| Bladder Spasms | 2% in prospective study Designed to be minimally invasive. No balloon pressure on the trigone, reducing the likelihood of anticholinergic use. N=50. 1 | 34.7% with catheter in place 34.7% reported urgency/spasms while catheterized; 24.0% continued post-removal. Balloon pressure on trigone is a recognized contributor. 2 |
| Tissue Contact & Inflammation | 4.5–6.5 mm proximal tip Compressible silicone wings. No sustained rigid pressure on trigone or bladder wall. 7 | Balloon-induced tissue damage Inflated balloon exerts continuous pressure on bladder trigone. Histologic inflammation and damage onset within 6 hours. 11 |
| Accidental Dislodgement | Wings compress through urethra Retention tested at 1 lb (0.45 kg) per ASTM F623. 6 Two cases in N=50 cohort confirmed zero trauma on dislodgement. 1 | Balloon resists extraction 10 mL balloon requires ~3.8 kg (8.4 lbs) to forcibly remove in female cadavers 5, ~9.3 lbs in males 4. Risks urethral laceration and stricture. |
| Home Use Considerations | Simplified activation Push-to-deploy / pull-to-retract eliminates syringe handling. No risk of intraurethral balloon inflation during self-insertion. 8 | Requires syringe for balloon. Self-inflation/deflation adds risk of intraurethral balloon inflation, incomplete deflation, and syringe malfunction. |
| Device Versatility | 3-in-1 device FDA-cleared for indwelling, intermittent, and suprapubic catheterization in a single device. Eliminates need to stock multiple catheter types. 8 | Single function per device. Foley (indwelling), straight (intermittent), and suprapubic catheters are separate products with different designs, packaging, and SKUs. |
Competitive Reality
Why coatings aren't enough
The largest randomized controlled trial of antimicrobial catheters, 7,102 patients across 24 hospitals, found no clinically significant reduction in symptomatic CAUTI.12 Coatings treat a symptom. Lotus addresses the cause.
The fundamental question
Coated catheters ask: how do we reduce bacteria on a balloon-based design?
Lotus asks: what if we remove the balloon entirely?
Coated Foley Catheter
Silver-alloy, nitrofurazone, antimicrobial variants
No significant benefit for symptomatic CAUTI. A 7,102-patient RCT found silver alloy catheters reduced symptomatic CAUTI by just 0.1% vs. standard catheters, a difference that was not statistically or clinically significant.12 A 2022 meta-analysis of 36,783 patients across 12 RCTs confirmed the finding (RR 0.87, p=0.06).14
Still pools residual urine above the balloon. The stagnant reservoir associated with bacterial colonization remains.1
Still exerts sustained pressure on the trigone. Biopsy-confirmed inflammation within 6 hours.11
Still associated with removal trauma. 30.9% report pain, bleeding, or discomfort.2
$5–$6+ premium per unit while preserving every structural limitation of the standard Foley.12
Lotus Catheter
Balloon-free, wing-based retention
~4.8 mL mean residual (N=50). Near-complete emptying, designed to reduce the residual urine associated with bacterial colonization.1
Compressible silicone wings. No sustained trigone pressure, 4.5–6.5 mm proximal tip.1
0% hematuria (N=50). Wings collapse at ~1 lb with no urethral damage observed in clinical trial.1
0% CAUTI observed (N=50). Designed to address the structural mechanism rather than coating over it.1
Priced to compete with standard Foleys without a premium surcharge.
What this means for catheter selection
The largest RCT to date found that antimicrobial coatings do not provide a clinically significant reduction in symptomatic CAUTI, yet these products command premium pricing based on that claim.12 Meanwhile, every structural limitation of the balloon remains: residual urine, tissue trauma, spasms, and painful removal. Lotus is the only FDA 510(k)-cleared catheter that removes the balloon entirely, designed to address the structural cause rather than coating over it.
Reimbursement & Adoption
Same workflow. Same codes. Zero friction.
Lotus is reimbursed under established codes and inserted using identical clinical technique to the Foley, with no new training, no new billing pathways, and no formulary disruption.
Same billing code
Insertion billed under CPT 51702, the same code used for Foley catheterization. No new billing pathway required, no workflow disruption.
CPT 51702
Same insertion technique
Clinicians insert Lotus using the same procedure as a Foley. Wings deploy automatically once inside the bladder. No additional training or equipment required.
Cost-neutral to cost-positive
Priced to compete with standard Foleys. Designed to fit within existing CMS quality-program frameworks (HRRP, HACRP, CAUTI reporting) and support lower total cost of care.
FDA 510(k) K191512
Class II Medical Device
Patent Protected through 2045
ISO 13485 Certified Manufacturing
500K+ Units Globally
Independent Research
What the literature says
Researchers have identified the balloon as a structural root cause of catheter-associated complications for decades, but until Lotus, no commercially viable alternative existed.
"The mechanism of retention is arguably the pivotal aspect of design development."
Feneley RCL, Hopley IB, Wells PNT. Journal of Medical Engineering & Technology, 2015. The same research agenda proposes a catheter "retained by wings which spring open after insertion" (Figure 7), anticipating the wing-retention design Lotus has since commercialized. The authors estimated that even 50% of a better catheter's potential would save approximately $18 billion annually in the U.S. 7
Biopsy-confirmed tissue damage within 6 hours
The Foley catheter tip (2.5–3 cm) pressing into the bladder dome produces acute and chronic inflammatory changes at the cellular level within 6 hours of insertion, demonstrated by biopsy-confirmed studies. Lotus reduces proximal tip to 4.5–6.5 mm, designed to minimize sustained dome contact. 11
CMS non-reimbursement as a design forcing function
Since 2008, CMS has refused to reimburse hospitals for CAUTI treatment costs, classifying them as a preventable "never event." This created a direct financial incentive to move beyond the Foley, yet the industry offered no viable structural alternative until Lotus. 8
Request the full clinical data package
Peer-reviewed study summaries, clinical outcomes comparison data, published economic literature, and product evaluation samples.
References
- Lockhart J, Boyle A, Kidd LC, et al. The Lotus Catheter: a Non-Balloon Novel Urethral Catheter, a Prospective Study. J Urol Ren Dis. 2017;125. View study →
- Saint S, Trautner BW, Fowler KE, et al. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018;178(8):1078-1085. View study →
- Centers for Disease Control and Prevention. Catheter-Associated Urinary Tract Infections (CAUTI), Background. cdc.gov →
- Wu AK, Blaschko SD, Garcia M, et al. Defining the optimal bladder volume for catheter removal after catheterization. BJU Int. 2012;109:1110-1114. View →
- Ito F, Greenberg AM. A pilot study comparing Foley catheter and CystoSure catheter balloon volumes and pullout forces in female cadavers. Arch Urol. 2018. View →
- Lotus 510(k) Section 18: Bench Testing, ASTM F623-2013, load test specification = 1 lb.
- Feneley RCL, Hopley IB, Wells PNT. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459–470. View →
- CMS Hospital-Acquired Condition (HAC) Reduction Program. 42 CFR §412.172.
- Hooton TM, Bradley SF, Cardenas DD, et al. Diagnosis, Prevention, and Treatment of CAUTI in Adults: 2009 International Clinical Practice Guidelines. Clin Infect Dis. 2010;50(5):625–663.
- Awad MA, Osterberg EC, Chang H, et al. Urethral catheters and medical malpractice: a legal database review from 1965 to 2015. Transl Androl Urol. 2016;5(5):762-773. View →
- Mohanty NK, Jha AK, Sharma SK, et al. Mitochondrial DNA induces Foley catheter related bladder inflammation via Toll-like receptor 9 activation. Sci Rep. 2018;8:6738. View →
- Pickard R, Lam T, MacLennan G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380(9857):1927-1935. View study →
- Judy BF, Kessler S, Gelman S, et al. Descriptive analysis of healthcare resource utilization and costs associated with treatment of urinary tract infections in United States hospitals. Am J Infect Control. 2022;50(2):190-198. View study →
- Barchitta M, Maugeri A, Favara G, et al. Catheter-Associated Urinary Infections and Consequences of Using Coated versus Non-Coated Urethral Catheters, Outcomes of a Systematic Review and Meta-Analysis of Randomized Trials. J Clin Med. 2022;11(15):4463. View study →
