FDA 510(k) Cleared
Patented
500K+ Units Globally
FDA 510(k) Cleared · Patented · 500K+ Units
The balloon era is over
A Revolution.
One catheter replaces three. Zero balloons.
FDA-cleared for Foley, straight, and Malecot indications — engineered to remove the source of infection and restore patient comfort.
FDA-cleared for Foley, straight, and Malecot indications — engineered to remove the source of infection and restore patient comfort.
Clinicians & Hospitals
View Clinical Evidence
Distributors & GPOs
Explore Partnerships
The Foley catheter hasn’t fundamentally changed since 1933. The balloon-based retention mechanism, the structural cause of trauma, infection, and patient discomfort, has remained unchallenged. Until now.
Lotus® is the first and only urinary catheter FDA 510(k)-cleared for the same indications as Foley, Malecot, and straight catheters in a single device — designed to improve patient outcomes and reduce total cost of care.
The future of catheters starts
now.
evolve
By the Numbers
The cost of an outdated design
Up to 0%
Of All Hospital-Acquired Infections
Catheter-associated urinary tract infections account for up to 40% of all hospital-acquired infections worldwide — making CAUTIs the single largest category of healthcare-associated infections. 1
~
0%
Linked to Catheters
Virtually all healthcare-associated UTIs are caused by instrumentation of the urinary tract, per CDC guidelines. 2
~
0+
Deaths Annually
CDC estimated annual deaths associated with healthcare-associated UTIs in the United States alone. 3
$
0M+
Annual Cost
The Agency for Healthcare Research & Quality (AHRQ) estimates that CAUTIs cost the U.S. healthcare system between $340 million and $450 million annually. 4
When a CAUTI Occurs
0 days
Mean Hospital Stay
CAUTI patients average 8.4 days in hospital — significantly longer than complicated UTI (5.5 days). Each additional bed-day is capacity lost. 9
0%
Require ICU
Nearly one in four CAUTI patients require intensive care unit admission — consuming the highest-cost beds in the facility. 9
>0×
Mortality Risk
Greater than 2-fold increase in unadjusted mortality (3.6% vs. 1.6%) — a direct quality metric and growing source of liability exposure. 9
0%
Readmitted with UTI
24% of CA-UTI patients are readmitted with a UTI diagnosis within one year — with rates climbing to 26% in skilled nursing facilities. 5
The Financial Burden
Per-Event Cost
$0
Median Cost per CAUTI Episode
Each CAUTI episode generates a median hospital cost of $9,496, with 42% of patients readmitted for any cause within one year — climbing to 44% for SNF patients. CMS data shows CAUTI 30-day readmission rates of 20.3% vs. a 15.4% baseline, a 4.9 percentage point excess directly attributable to the infection. 5 10
CMS Penalties
Up to 0%
Medicare Payment Reduction
6 Hours
Tissue Damage Onset
Biopsy-confirmed acute and chronic inflammation at the bladder dome occurs within 6 hours of Foley catheter insertion. The Lotus catheter's 0.5 cm tip eliminates this sustained mechanical pressure entirely. 8
Feneley, Hopley & Wells
Journal of Medical Engineering & Technology
A Clinical Comparison
Lotus vs. Foley
Prospective clinical trial data compared against published findings from JAMA Internal Medicine.
| Metric |
Lotus®
Catheter Balloon-Free |
Foley Catheter
Balloon-Based
|
|---|---|---|
| Insertion & Removal | ~4 sec insertion · ~3 sec removal Single step — push to deploy, pull rod to retract. No syringe, no inflation, no separate supplies. 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. 1 Zero infections | 5.7% diagnosed UTI 5.7% told they had UTI; 10.5% reported any infectious complication (fever, chills, burning, urgency). 2 Balloon-linked risk |
| Residual Urine | 4.8 mL mean PVR Bladder scanner confirmed. PVR >0 in only 8 of 50 patients. Near-complete drainage — lumen rests at bladder neck. 1 Near-complete drainage | 77 mL mean PVR Vs. 0 mL for straight catheters. Balloon elevates lumen above pooled urine, preventing complete emptying and promoting bacterial colonization. 1* Residual urine pool |
| Patient Discomfort | 0/10 insertion · 2/10 removal Wong-Baker scale. Mean insertion discomfort 0 (no pain). Mean removal discomfort 2/10. 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. 1 Wings compress safely | 30.9% removal complications Composite: pain, discomfort, bleeding, and/or trauma during removal. Separately, 10.0% reported blood in urine while catheterized. 2 Balloon extraction risk |
| Bladder Spasms | 2% (1 of 50) One patient experienced spasms, resolved with short-course anticholinergic medication. May have been procedure-related. 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. 3 |
| Accidental Dislodgement | Wings compress through urethra Retention tested at 1 lb (0.45 kg) per ASTM F623. 6 Two clinical cases 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, 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. |
Mechanism of Action
Near-Complete Emptying. By Design.
The Lotus Catheter's lumen sits low at the trigone — the bladder's natural drainage point — enabling near-complete emptying without a balloon obstructing flow.
Lotus Catheter
Foley Catheter
VS
Residual: ~4.8 mL
Incomplete drainage
Lumen at the Trigone
The Lotus Catheter's drainage eye sits at the lowest anatomical point of the bladder — the trigone — allowing urine to drain by gravity with near-complete emptying.
Balloon Elevates the Lumen
The Foley's inflated balloon lifts the drainage eye above the pooled urine. The balloon elevates the drainage lumen, preventing complete emptying — creating a stagnant reservoir that harbors bacteria. 1
The Patient Reality
What the data shows.
A JAMA Internal Medicine study of 2,076 patients across 4 U.S. hospitals found that catheter harm extends far beyond infection alone. These are the outcomes associated with balloon-based indwelling catheterization.
57%
reported at least one complication within 30 days
55%
experienced noninfectious harms — pain, bleeding, urgency, leaking
31%
reported trauma during catheter removal
44%
reported restrictions in social activity while catheterized
Saint S, et al. JAMA Intern Med. 2018;178(8):1078-1085.
View study ↗
One device, many uses
What it replaces
The Lotus No-Balloon Catheter does the job of three legacy devices, without a balloon.
Replaces straight catheter
Sleep through the night again.
Patients on intermittent straight catheters wake multiple times a night to re-catheterize — disrupting sleep and quality of life. Lotus is FDA-cleared for intermittent catheterization with a self-contained bellows mechanism that requires no balloon or syringe, enabling patient self-use at home as an indwelling catheter.
Replaces Foley catheter
Retention without the damage.
The Foley balloon presses against the trigone and bladder neck, while the catheter tip presses against the bladder dome — causing granuloma, residual urine, bladder spasm, and the conditions that lead to catheter-associated infections (CAUTI). Lotus eliminates the balloon entirely, using soft, deployable wings that anchor gently without pressure or irritation to the trigone and bladder neck. Clinical study showed no residual urine when using the Lotus Catheter.
Replaces Malecot catheter
Simplified from the start.
Malecot catheters require two separate stylets — one for placement, another for removal — adding procedural complexity and a risk of tissue perforation during removal. Lotus is FDA-cleared for the same indications with a self-contained bellows mechanism that eliminates the need for stylets entirely.
The Inventor
Dr. Said I. Hakki, MD, PhD
Urologist, Professor & Inventor
A globally recognized urologist and medical device inventor with over five decades in clinical practice. In the early 1980s, Dr. Hakki patented an inflatable penile prosthesis acquired by American Medical Systems (later Pfizer) — a device that has since generated an estimated $1.9 billion in cumulative revenue and restored sexual function for hundreds of thousands of men worldwide.
The Lotus Catheter is his next breakthrough: a balloon-free design built on tens of thousands of patient interactions and a career-long conviction that the Foley's retention mechanism was an unnecessary source of harm.
80+
International Patents
50k+
Urological Procedures
50+
Years in Urology
2
Fortune 50 Technology Licenses
From the Inventor
Hear Dr. Hakki explain the difference
A 12-minute walkthrough of Lotus vs. Foley — covering mechanism of action, clinical data, and why balloon-free retention changes the standard of care.
Reimbursement & Regulatory
Existing codes. Familiar workflow. No adoption friction.
Lotus is reimbursed under established HCPCS codes and inserted using the same clinical procedure as a Foley catheter — no new billing pathways, no prior authorization burden, no workflow disruption.
Reimbursed under existing codes
Insertion is billed under CPT 51702, the same code used for Foley catheterization — no new billing pathways, no prior authorization burden, no workflow disruption.
CPT 51702Designed to be cost-neutral to cost-positive
Priced to compete with Foley catheters while delivering category-defining clinical outcomes. When factoring in CAUTI prevention, reduced CMS penalties, and elimination of anticholinergic prescriptions, Lotus is designed to lower total cost of care.
Manufactured for scale
Produced in ISO 13485-certified facilities with capacity to support national and international distribution. Supply redundancy and quality systems are designed to meet the procurement requirements of large health systems and GPO contracts.
FDA 510(k) K191512
Class II Medical Device
Patent Protected through 2045
500K+ Units Globally
Work With Us
Ready to move beyond the balloon?
Whether you're evaluating Lotus for clinical use or exploring a distribution or GPO partnership, we have the data and support structure to move quickly.
For Clinicians: See the data.
Evaluate Lotus with your team. We provide clinical data packages, product samples for hands-on evaluation, and direct access to our medical team.
- Full clinical study results
- Head-to-head comparison data vs. Foley
- Product evaluation samples
- CAUTI reduction economic modeling
For Partners: Own the future.
Join a global network bringing balloon-free catheter technology to market — through territory-based distribution partnerships or GPO formulary integration.
- Exclusive territory agreements available
- GPO formulary evaluation & value analysis support
- Marketing, clinical training & regulatory dossier assistance
- CMS penalty reduction and CAUTI program alignment
In the News
Press & announcements
Yahoo Finance
FDA-Cleared Lotus Catheter Accelerates Global Expansion, Backed by Peer-Reviewed Zero-UTI Study and 500,000+ Uses
Gavin Publishers — Peer Reviewed
The Lotus Catheter: A Non-Balloon Novel Urethral Catheter — A Prospective Study (50-Patient Clinical Trial, 0% CAUTI)
FDA · AccessData
510(k) Premarket Notification K191512 — Hakki Urinary Catheter, Class II Medical Device
Let's end the balloon era — together.
Whether you're a hospital system evaluating alternatives to the Foley, a GPO exploring formulary consolidation, or a distributor seeking a differentiated portfolio product — we're ready to move quickly.
team@lotus-catheter.com
Typically respond within 24 hours
