13485:2016
When Every Minute Matters: Danis Stent for Acute Esophageal Variceal Bleeding

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.