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Foley-Safe · Advanced Active Catheter Securement

When Securement Alone Is Not Enough.

Advanced Active Catheter Securement for a More Intelligent Response to Traction

A Foley catheter may be correctly inserted, appropriately secured, and carefully managed—and still become a patient-safety concern when unexpected pulling occurs.

A confused patient pulls.A drainage line catches.A patient turns, transfers, or attempts to get out of bed.

And when significant force is transmitted against an inflated retention balloon, passive securement alone may not address the full risk.

Foley-Safe introduces a different approach.

Foley-Safe catheter securement device with a Foley catheter threaded through the mechanism
Foley-Safe · Cathetrix Ltd., Israel
Routine conditions

Secure during routine care.

Helps stabilize the catheter and minimize unnecessary movement.
Significant traction

Designed to respond.

An integrated mechanism engages before an inflated balloon is forcibly pulled.

Patented TechnologyProfessional UseTraction-Responsive Design

Continue — see how securement has evolved ↓
Stage 2 of 8Securement has evolved

Securement has evolved

From Passive Holding to Active Protection

Traditional catheter securement devices are primarily designed to keep the Foley catheter in position.

That remains important.

But Foley-Safe addresses another question:

What happens when the pull becomes stronger than the system should simply resist?

Developed by Cathetrix Ltd., Israel, Foley-Safe is a patented catheter securement device engineered to:

01

Stabilize

Help minimize unnecessary catheter movement during routine care.

02

Control

Support catheter positioning during movement, repositioning, and normal bedside activity.

03

Respond

Provide an active mechanical response when significant traction threatens accidental or unintended catheter extraction.

This is the distinction behind Foley-Safe.

Not simply stronger fixation. A more intelligent response to changing levels of force.

Stage 3 of 8Three layers of protection

Three layers of protection

Fixation. Movement Control. Active Disconnection.

01

Fixation

An adhesive securement platform anchors the Foley catheter to the patient’s thigh.

During normal care, Foley-Safe helps stabilize the catheter while allowing the clinical team to maintain an organized catheter-management system.

02

Movement Control

Routine patient movement does not always require a safety mechanism to activate. Foley-Safe is designed to help minimize unnecessary catheter movement during:

  • Repositioning
  • Bedside care
  • Patient movement
  • Transfers
  • Long-term catheter management

The objective is controlled securement during ordinary conditions.

03

Active Disconnection

This is where Foley-Safe becomes fundamentally different.

When significant traction reaches the point where catheter dislodgement would otherwise occur, Foley-Safe’s integrated cutting mechanism is designed to sever the catheter lumen.

This allows the Foley retention balloon to deflate.

The objective is to help reduce the risk of an inflated retention balloon being forcibly pulled through the urethra.

Watch the mechanism

Introducing Foley-Safe

See how Foley-Safe secures the catheter during routine care—and how its integrated mechanism is designed to respond when significant traction occurs.

Stage 4 of 8Why this matters

Why this matters

A Foley Catheter Can Be Secure—and Still Become a Risk

A Foley catheter is retained inside the bladder by an inflated balloon.

During normal catheterization, that balloon performs an essential function.

During significant traction, however, the same balloon may become a point of resistance.

Potential traction events can occur during:

Patient confusion or disorientationAgitation or restlessnessTurning and repositioningBed or wheelchair transfersAttempts to get out of bedAccidental pullingDrainage tubing becoming caughtLong-term catheter management

A forceful pull against an inflated retention balloon may be associated with pain, bleeding, traumatic extraction, reinsertion, and additional clinical intervention.

The question is not simply

“Is the catheter secured?”

The more important question

“How does the securement system respond when routine movement becomes significant traction?”

Stage 4 of 8Stronger hold ≠ smarter protection

Stronger Hold Is Not Always Smarter Protection

Passive fixation is valuable during routine catheter management.

But high-force traction creates a different clinical challenge.

IF FIXATION REMAINS RIGID

Force Transmits

During an excessive pulling event, force may continue to be transmitted toward vulnerable tissue.

IF FIXATION FAILS UNPREDICTABLY

Displacement

The catheter may still be displaced traumatically.

FOLEY-SAFE · A THIRD APPROACH

Respond

Secure appropriately during routine conditions. Respond differently when the force becomes excessive.

Its active mechanism is designed to engage when significant traction threatens accidental or unintended extraction.

That is the difference between passive securement and active catheter protection.

Stage 5 of 8Designed around real patients

Designed around real patients

Because Patients Do Not Always Remain Still

Some patients cannot reliably protect their catheter.

They may become confused.They may pull at tubing.They may have limited body awareness.They may move repeatedly during prolonged catheterization.

Foley-Safe is intended for adult patients with indwelling urinary catheters and may be particularly relevant for appropriately selected patients at increased risk of inadvertent catheter movement or possible extraction.

Potential patient profiles include:

Disoriented or Confused Patients

Where cognition or awareness may increase the likelihood of unintended traction.

Patients With Limited Body Awareness

Where catheter position may not be reliably recognized or protected.

Elderly or Higher-Risk Patients

Where additional catheter-management considerations may be appropriate.

Long-Term Catheter Users

Where repeated movement and prolonged exposure create ongoing securement considerations.

Patients Vulnerable to Accidental Traction

Where clinical assessment identifies increased risk of unintended pulling or catheter displacement.

Patient selection remains a professional clinical decision.

Stage 5 of 8Clinical perspectives

One Technology. Different Clinical Perspectives.

Choose your role to see what matters most when evaluating Foley-Safe.

Top view of Foley-Safe showing the catheter channel and integrated mechanism
For doctors

Add Another Layer to Catheter Safety

Evaluate Foley-Safe in relation to:

  • Patient selection
  • Catheter compatibility
  • Mechanism of action
  • Contraindications and precautions
  • Activation behavior
  • Post-activation management
  • Clinical workflow
  • Technical documentation
Request Clinical Evaluation

Advanced by design

Foley-SafeDoes Not Simply Hold

The difference is not merely how securely the catheter is held. It is how the system is engineered to respond when securement reaches its limit.

Top view of Foley-Safe showing the catheter channel and integrated mechanism
Integrated traction-responsive mechanism
Routine movement
Routine movementSignificant traction
Conventional passive securement
Primary objective
Maintain catheter position
During routine movement
Helps control motion
During significant traction
Continues to depend primarily on fixation behavior
Resulting mechanical response
—

Holding · helps control motion

Foley-Safe
Primary objective
Catheter securement plus traction-responsive protection
During routine movement
Helps stabilize the catheter
During significant traction
Integrated cutting mechanism is designed to sever the catheter lumen when dislodgement would otherwise occur
Resulting mechanical response
Allows the retention balloon to deflate

Holding · helps stabilize the catheter

Stage 6 of 8Patented & documented

Premium technology should be documented

Patented. Defined. Professionally Reviewable.

Foley-Safe’s underlying technology is supported by an international patent portfolio including:

PatentUnited States

US 9,402,972

PatentEurope

EP 3049142

PatentChina

ZL 201480072281.X

PatentCanada

CA 2929289

The patented concept includes a catheter add-on incorporating a mechanism adapted to sever the catheter in response to a predefined pulling force.

Foley-Safe is also supported by documented regulatory, quality, technical, and risk-management information, including:

EU Declaration of ConformityClass I classification under MDR Rule 1ISO 13485:2016 quality-management certificationTechnical documentationFormal risk-management documentationCurrent Instructions for Use

Documented technology for professional evaluation.

Stage 6 of 8Product compatibility

Product compatibility

Designed for Defined Clinical Use

According to the current Instructions for Use, Foley-Safe is intended for:

Patient populationAdults
Catheter typeIndwelling urinary catheter
Compatible configuration2-way Foley catheter
Compatible sizes12–16 Fr
UseSingle use
SterilityNon-sterile
Intended userHealthcare professional
Important use limitations

Foley-Safe should not be used:

  • With 3-way catheters
  • With catheter sizes below 12 Fr or above 16 Fr
  • Where insufficient exposed catheter length prevents correct placement
  • Where skin integrity is unsuitable
  • In patients with known tape or adhesive allergies

The device should be replaced after activation.

Always refer to the current Instructions for Use and applicable institutional or clinical protocols before use.

Request Current IFU
Stage 7 of 8Value beyond the device

The value extends beyond the device

A Traction Event Can Affect the Entire Care Pathway

A significant catheter event may require more than catheter replacement.

Depending on the clinical circumstances, it may also lead to:

  1. Patient assessment
  2. Additional nursing intervention
  3. Physician involvement
  4. Monitoring for bleeding or injury
  5. Urology consultation
  6. Catheter reinsertion
  7. Documentation
  8. Incident review
  9. Quality-management activity
  10. Communication with the patient or family
  11. Potential escalation of care

Foley-Safe should therefore be evaluated not simply as a catheter holder.

It is an active catheter-safety technology designed around a specific clinical risk.

Stage 7 of 8A responsible approach

A Responsible Approach to Catheter Safety

No catheter securement device can guarantee a specific clinical outcome.

Risk depends on multiple factors

  • Patient condition
  • Catheter type
  • Placement technique
  • Skin integrity
  • Direction and magnitude of traction
  • Monitoring
  • Clinical follow-up

Premium medical technology should earn confidence through

  • Defined intended use.
  • Transparent limitations.
  • Documented engineering.
  • Professional evaluation.

Foley-Safe should therefore be evaluated according to its documented intended function:

To help minimize catheter movement and provide a mechanical safety response when significant traction threatens accidental or unintended catheter extraction.
Stage 7 of 8See it in practice

See Foley-Safe in practice

Seeing the Mechanism Makes the Difference Clearer

Understanding the concept is important.

A professional demonstration can show:

Correct placement
Catheter slack
Securement orientation
Normal fixation
Traction-response mechanism
Balloon-deflation principle
Activation behavior
Replacement procedure
Appropriate-use considerations
Stage 7 of 8Frequently asked questions

Frequently Asked Questions

What is Foley-Safe?

Foley-Safe is a catheter securement device with an integrated cutting mechanism designed to help minimize catheter movement and provide an active response when significant traction threatens accidental or unintended Foley catheter extraction.

How is Foley-Safe different from a conventional catheter holder?

Traditional catheter securement is mainly passive.

Foley-Safe adds a traction-responsive mechanical function.

When significant pulling force reaches the point where catheter dislodgement would otherwise occur, the internal mechanism is designed to sever the catheter lumen and allow the inflated retention balloon to deflate.

Does Foley-Safe intentionally cut the catheter?

The integrated mechanism is designed to sever the catheter lumen only in the defined high-traction circumstance described in the product documentation—when significant pulling force threatens catheter dislodgement.

This enables balloon deflation and changes how the catheter responds to the traction event.

Why is balloon deflation important?

The Foley retention balloon normally keeps the catheter positioned within the bladder.

During significant traction, however, an inflated balloon may become a point of resistance.

Foley-Safe’s mechanism is designed to allow the balloon to deflate during activation, with the objective of reducing the risk associated with forcible extraction of an inflated balloon through the urethra.

Is Foley-Safe suitable for every catheterized patient?

No.

Foley-Safe is intended for appropriately selected adult patients with indwelling urinary catheters.

Patient condition, catheter configuration, skin integrity, clinical environment, and other factors should be assessed by the healthcare professional.

Which Foley catheters are compatible?

The current Instructions for Use specify 2-way Foley catheters from 12–16 Fr.

Can Foley-Safe be used with a 3-way catheter?

No.

The current Instructions for Use state that Foley-Safe should not be used with 3-way catheters.

Is Foley-Safe reusable?

No.

Foley-Safe is a single-use device.

After activation, it should be discarded and replaced if continued catheter securement is required.

What happens after Foley-Safe activates?

When significant pulling force activates the mechanism, the catheter lumen is designed to be severed, allowing the retention balloon to deflate.

The catheter should then be managed by a caregiver according to the current Instructions for Use and applicable clinical protocol.

Does Foley-Safe guarantee prevention of urethral injury?

No medical device should be represented as guaranteeing zero injury.

Foley-Safe is designed to help reduce the risk associated with significant catheter traction and accidental or unintended extraction.

Can our hospital review the supporting documentation?

Yes.

Clinical, procurement, nursing, quality, and technical stakeholders may request appropriate documentation for institutional evaluation.

Can we arrange a product demonstration?

Yes.

Healthcare institutions and appropriate professional users may request an orientation or product demonstration.

Foley-Safe

The next generation of catheter securement is not just about holding tighter.

It is about knowing how the system should respond when the pull becomes too strong.

Routine careSecureSignificant tractionDesigned to respond

When Securement Alone Is Not Enough.

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Professional-use notice

Foley-Safe — Active Catheter Securement for a More Intelligent Response to Traction. Developed by Cathetrix Ltd., Israel. For professional healthcare use.

Foley-Safe should be used only according to the current Instructions for Use, applicable institutional policies, and appropriate clinical judgment. No medical device can guarantee prevention of catheter-related injury or a specific clinical outcome.

Stage 1 of 8Overview
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