Peer-reviewed outcomes, comparative clinical data, and independent evidence, consolidated to support value analysis committees, clinical review boards, and procurement teams.
Peer-reviewed outcomes, comparative clinical data, and independent research, consolidated to support value analysis committees, clinical review boards, and procurement teams.
Near-complete bladder emptying. The Foley balloon obstructs the drainage eye, resulting in pooled residual urine that is associated with bacterial colonization.
No catheter-associated UTIs were observed in a prospective clinical trial of 50 patients. Observational data from JAMA Internal Medicine reported a 5.7% rate of diagnosed UTI and a 10.5% rate of composite infectious complications among catheterized patients.
Identical CPT code (51702), insertion technique, and billing workflow. No new training required, no new billing pathway, and no formulary friction.
According to JAMA Internal Medicine, more than half of catheterized patients develop complications, with noninfectious complications occurring 5× more frequently than infectious ones.
Patients pulling out a Foley catheter while the retention balloon is fully inflated is not a rare event. It can occur in psychiatric or behavioral health settings, when patients awaken from anesthesia, among confused or cognitively impaired geriatric patients, and with agitated or combative patients.A bench study conducted in an FDA-registered, ISO 9000 laboratory measured the force required to remove inflated Foley catheter balloons using ASTM performance specifications. A 28 Fr funnel-like apparatus simulated the bladder outlet and urethra. 63 siliconized latex Foley catheters (sizes 14F–24F) were tested at inflation volumes of 5cc, 10cc, 15cc, and 20cc, using a calibrated digital force gauge (+/- 0.2% accuracy). Three pure silicone catheters were also tested
Read MoreA landmark JAMA Internal Medicine study followed 2,076 catheterized patients across 4 U.S. hospitals. Safety programs focus almost exclusively on CAUTI—yet noninfectious complications (pain, bleeding, urgency, leaking, skin trauma) affected 5 in 9 catheterized patients. These balloon-related complications go entirely undetected by surveillance systems.
View documentComplication Rate
Noninfectious vs. Infectious
At follow-up, 39.5% of patients still catheterized reported restrictions in daily living, and 43.9% reported limitations in social activity. The study authors termed the indwelling catheter a 'one-point restraint,' a burden that current quality metrics do not measure.
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Patients reported pain or discomfort while the catheter remained indwelling.
View documentA 50-year review of legal database records found that 48% of malpractice claims related to catheters involved traumatic insertion. Several lawsuits included spousal claims of loss of consortium. For facilities and care teams, balloon-based catheterization represents an expanding liability exposure.
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Saint S, Trautner BW, Fowler KE, et al. JAMA Intern Med. 2018;178(8):1078-1085. doi:10.1001/jamainternmed.2018.2417
View documentAmong 2.5 million hospitalized UTI patients (Premier Healthcare Database), CAUTI carried the highest readmission burden of any UTI subtype—with skilled nursing facility patients at even greater risk
Among SNF patients, 26% were readmitted with a UTI diagnosis within one year
44% for CAUTI patients admitted from skilled nursing facilities
HRRP penalties: up to 3% of Medicare reimbursement for excess readmissions. HAC Reduction Program: separate penalties for bottom-quartile performers. CAUTI readmissions count toward both—making catheter-associated infection a compounding financial liability.
Among all UTI subgroups, patients admitted from skilled nursing facilities with CAUTI demonstrated the highest readmission rates—44% all-cause and 26% UTI-related at one year. This population also carries the greatest burden of long-dwell indwelling catheters, rendering it the setting most impacted by the downstream costs of catheter-associated infection.
Judy, B. F., Kessler, S., Gelman, S., et al. (2022). Descriptive analysis of healthcare resource utilization and costs associated with treatment of urinary tract infections in United States hospitals. American Journal of Infection Control, 50(2), 190-198. https://doi.org/10.1016/j.ajic.2021.03.015
Per CAUTI episode, costs ranged from $5,568 to $17,844 (IQR), with a median length of stay of 5 days
Prospective trial data vs. published JAMA Internal Medicine findings
Journal of Urology & Renal Diseases · 2017 · Peer-reviewed
A prospective 50-patient trial evaluated the Lotus catheter across multiple urological indications, with assessments for CAUTI incidence, residual urine, pain, hematuria, and bladder spasms
Read the full study →CAUTI
No CAUTIs observed — 50-patient prospective trial
Reading this table: Lotus (N=50, prospective single-center trial) vs. Foley (N=2,076, multicenter observational study). Different designs, populations, and endpoints—so this compares published outcome ranges, not head-to-head trial data
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.
Single step, push to deploy, pull rod to retract. No syringe, no inflation, no separate supplies. N=50.
Requires syringe for balloon inflation on insertion and deflation on removal. Incomplete deflation risks urethral trauma during extraction.
Prospective clinical trial, N=50.
Within 30 days. Noninfectious complications were 5× more common than infectious. N=2,076.
Zero urinary tract infections detected across entire prospective cohort. N=50.
5.7% told they had UTI; 10.5% reported any infectious complication (fever, chills, burning, urgency). N=2,076.
Near-complete drainage. Lumen rests at bladder neck. Prospective study, N=50.
Vs. 0 mL for straight catheters. Balloon elevates lumen above pooled urine, preventing complete emptying and promoting bacterial colonization.
Wong-Baker scale. Mean insertion discomfort 0 (no pain). Mean removal discomfort 2/10. N=50.
Pain or discomfort with catheter in place, patient-reported (n=124 subgroup).
No gross hematuria at insertion. Two accidental dislodgements caused zero urethral injury, no hematuria. N=50 cohort.
Composite: pain, discomfort, bleeding, and/or trauma during removal. Separately, 10.0% reported blood in urine while catheterized.
Designed to be minimally invasive. No balloon pressure on the trigone, reducing the likelihood of anticholinergic use. N=50.
34.7% reported urgency/spasms while catheterized; 24.0% continued post-removal. Balloon pressure on trigone is a recognized contributor.
Compressible silicone wings. No sustained rigid pressure on trigone or bladder wall.
Inflated balloon exerts continuous pressure on bladder trigone. Histologic inflammation and damage onset within 6 hours.
Retention tested at 1 lb (0.45 kg) per ASTM F623. Two cases in N=50 cohort confirmed zero trauma on dislodgement.
10 mL balloon requires ~3.8 kg (8.4 lbs) to forcibly remove in female cadavers, ~9.3 lbs in males. Risks urethral laceration and stricture.
Push-to-deploy / pull-to-retract eliminates syringe handling. No risk of intraurethral balloon inflation during self-insertion.
Self-inflation/deflation adds risk of intraurethral balloon inflation, incomplete deflation, and syringe malfunction.
FDA-cleared for indwelling, intermittent, and suprapubic catheterization in a single device. Eliminates need to stock multiple catheter types.
Foley (indwelling), straight (intermittent), and suprapubic catheters are separate products with different designs, packaging, and SKUs.
No clinically significant reduction in symptomatic CAUTI was found in the largest randomized controlled trial of antimicrobial catheters (7,102 patients, 24 hospitals). Coatings treat a symptom; Lotus targets the cause
Largest RCT to date: antimicrobial coatings show no clinically significant reduction in symptomatic CAUTI—yet carry premium pricing on that claim. Every balloon limitation remains: residual urine, tissue trauma, spasms, painful removal. Lotus is the only FDA 510(k)-cleared catheter that removes the balloon entirely—addressing the structural cause, not coating over it
Reimbursed under established codes. Inserted using the same technique as the Foley. No new training, no new billing pathways, no formulary disruption.
Insertion billed under CPT 51702, the same code used for Foley catheterization. No new billing pathway required, no workflow disruption.
Clinicians insert Lotus using the same procedure as a Foley. Wings deploy automatically once inside the bladder. No additional training or equipment required.
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) cleared (K191512), Class II medical device, patent protected through 2045, ISO 13485 certified manufacturing, 500K+ units globally.
Researchers have identified the balloon as a structural root cause of catheter-associated complications for decades, but until Lotus, no commercially viable alternative existed.
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.
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.
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.
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.
