A purpose-designed,
removable esophageal stent that supports rapid bleeding control and provides a
wider window for definitive treatment.
Acute esophageal
variceal bleeding is one of the most critical emergencies encountered in
gastroenterology.
The clinical priority is
immediate: stabilize the patient, control the hemorrhage, and create enough
time for the multidisciplinary team to plan the next stage of treatment. When
bleeding is massive, recurrent, or refractory to standard medical and endoscopic
management, the available rescue option must be fast, effective, and suitable
for emergency use.
The SX-ELLA Stent
Danis, manufactured by ELLA-CS, was developed specifically to help
control acute and refractory bleeding from esophageal varices.
Unlike conventional
esophageal stents designed primarily to manage strictures or malignant
dysphagia, the Danis Stent is a removable, fully covered nitinol stent
created for emergency variceal bleeding management. It is supplied in a
dedicated procedure pack containing the essential components required for
implantation.
The Challenge of
Refractory Variceal Bleeding
Standard management of
acute variceal hemorrhage may include pharmacological therapy, endoscopic
treatment, blood-product support, and escalation to radiological or surgical
intervention when necessary.
However, bleeding may
continue or recur despite initial treatment.
Historically, balloon
tamponade has been used as a temporary rescue measure in severe cases. Although
it can provide short-term compression, its use is generally limited by the
short duration for which it can remain in place and the risk of serious complications.
This creates a critical
need for an alternative that can provide sustained mechanical compression while
offering clinicians a longer stabilization period.
The Danis Stent
addresses this need by applying radial pressure to the esophageal wall and
varices while maintaining an open esophageal lumen.
How the Danis Stent
Works
Following deployment,
the self-expanding nitinol structure applies controlled pressure to the
bleeding varices.
The stent is fully
covered and designed to remain in place temporarily. According to the supplied
ELLA-CS materials, it may remain implanted for up to seven days,
compared with balloon tamponade, which is typically removed within
approximately 24–36 hours.
This extended period can
provide clinicians with valuable time to stabilize the patient and arrange
definitive management. The materials also report immediate bleeding control in 88%
of patients across the cited clinical evidence.
The stent’s open lumen
represents another important distinction from balloon tamponade. Rather than
obstructing the esophageal passage with an inflated balloon, the expanded stent
supports bleeding control while preserving the lumen.
Designed for Emergency
Deployment
In a life-threatening
hemorrhage, treatment complexity can become a barrier.
The Danis Stent
incorporates a dedicated delivery system designed to support implantation
without mandatory endoscopic or fluoroscopic control. This can be particularly
valuable in emergency situations where immediate access to specialized imaging
equipment may be limited.
Placement must
nevertheless be performed by appropriately trained healthcare professionals in
accordance with the applicable instructions for use and institutional emergency
protocols.
The delivery system has
a standard active length of 60 cm, with outer diameters of 28 F and
20 F. The stent itself has:
·
A 25 mm body diameter
·
30 mm flared ends
·
A 135 mm nominal length
These specifications
apply to both the complete Danis Procedure Pack and the Basic Procedure Pack.
A Complete Procedure
Pack
Emergency preparedness
is not only about having the correct device. It is also about ensuring that the
required components are immediately available.
The complete Danis
Procedure Pack — REF 019-08S-25-135 is supplied in a portable case
containing:
·
A delivery system preloaded with the stent
·
A guidewire
·
50 ml and 20 ml syringes
·
A bite block
·
A paper emesis basin
·
A protective cloth
·
A waste bag with a plastic clip
A Basic Procedure
Pack — REF 019-08S-25-135-B is also available and contains the preloaded
delivery system, guidewire, and a 50 ml syringe.
By bringing the key
implantation components together, the procedure pack is designed to support
faster preparation during emergency care.
Features Supporting
Clinical Use
Fully Covered Nitinol
Construction
The self-expanding
metallic structure is designed to exert radial pressure against the esophageal
wall, supporting mechanical control of variceal bleeding.
Variable Stent Braiding
The manufacturer
describes the stent’s variable braiding as an anti-migration feature intended
to help maintain its position after deployment.
Metallic Retrieval Loops
Retrieval loops
facilitate endoscopic removal, with the stent designed to be extracted within
seven days.
Open Esophageal Lumen
The open lumen
differentiates the stent from balloon-based compression and may support patient
management and comfort during the stabilization period.
Emergency-Oriented
Delivery System
The system is designed
to allow implantation without mandatory endoscopic or X-ray guidance, offering
flexibility in time-critical situations.
The clinical materials
supplied by ELLA-CS report fewer complications and serious adverse events with
the Danis Stent compared with balloon tamponade in acute refractory variceal
bleeding.
Potential Impact on ICU
Utilization
Beyond bleeding control,
emergency devices can influence the wider patient pathway.
The supplied clinical
presentation references NICE economic analyses indicating that Danis Stent use
may reduce intensive care unit stays by an estimated one to two days
compared with balloon tamponade.
These figures are based
on the referenced UK analysis and should not be interpreted as guaranteed
savings in every healthcare system. Actual economic impact will vary according
to local costs, protocols, patient condition, and treatment pathways.
A Bridge—Not the Final
Destination
Controlling the bleeding
is an essential first step, but it does not treat the underlying portal
hypertension.
The Danis Stent should
therefore be understood as a temporary stabilization and bridging solution.
Once hemostasis is achieved, the treating team can evaluate and proceed with
definitive therapies according to the patient’s condition and the institution’s
clinical protocol.
ELLA-CS notes that
esophageal self-expanding metal stents may be considered for variceal bleeding
that remains refractory to medical, endoscopic, or radiological therapy, as
well as in selected cases of massive bleeding.
More Time to Make the
Next Decision
During acute variceal
hemorrhage, every intervention has one immediate objective: gaining control.
But effective rescue
therapy must also create time—time to stabilize circulation, coordinate
specialist care, investigate the underlying cause, and prepare definitive
treatment.
Through its
self-expanding design, open lumen, emergency-oriented delivery system, and
temporary implantation period of up to seven days, the SX-ELLA Stent Danis
provides a specialized approach to one of gastroenterology’s most demanding
emergencies.
Because in critical
bleeding, control is not only about stopping the hemorrhage—it is about
creating the time needed to move forward.
About JAT Medical
JAT
Medical is committed to providing healthcare professionals with advanced
endoscopy technologies that support emergency preparedness, clinical
efficiency, and high-quality patient care.
To learn more about the Danis
Stent by ELLA-CS, request technical information, or discuss product
availability, contact the JAT Medical
Endoscopy team.