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Multi-stage oesophageal balloon dilatation catheter, 3 diameters (Amara™)

Multi-Stage Oesophageal Balloon DilatorAmara™ Balloon Dilatation Catheter · 3-Stage, Through-the-Scope

A single-use, through-the-scope (TTS) balloon dilatation catheter that reaches three distinct diameters at three set pressures — so one device covers a full progressive dilation of an oesophageal, pyloric or colonic stricture with no catheter exchange. Controlled radial expansion and rounded balloon shoulders keep the stricture in view throughout dilatation.

Oesophageal Balloon Dilator Features

  • Controlled radial balloon expansion designed to produce 3 distinct and precise diameters at 3 separate pressures during dilatation.
  • Catheter shaft designed with a high column strength to offer best-in-class pushability and
    torque control.
  • Compatible with min 2.8mm scope working channel.
  • High pressure balloon resistance designed to produce no balloon waisting.
  • Delivery over guidewires up to 0.035" under direct visualization or fluoroscopy.
  • Radiopaque marker band to confirm placement during fluoroscopy.
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Need a custom configuration or a private-label version? Explore our catheter design services, or see our ISO 13485 catheter manufacturing capabilities.

Indications & Clinical Applications

Progressive balloon dilatation of benign and malignant strictures of the upper and lower gastrointestinal tract, performed through the working channel of the endoscope under direct visualisation or fluoroscopy.

Oesophagus
Peptic and reflux strictures, anastomotic strictures, Schatzki ring, radiation stricture, and dysphagia secondary to benign narrowing.
Pylorus & Duodenum
Pyloric stenosis and gastric outlet obstruction, including post-surgical and peptic ulcer related narrowing.
Colon & Rectum
Colonic anastomotic strictures and inflammatory strictures, including Crohn's disease strictures amenable to endoscopic dilation.

Clinical applications listed for reference. Always refer to the Instructions for Use supplied with the device for the approved indications, contraindications and warnings. View Instructions for Use.

Balloon Diameters and Working Channel Sizes

Balloon sizes: 6-7-8, 8-9-10, 10-11-12, 12-13.5-15, 15-16.5-18 and 18-19-20 mm. Balloon lengths 3.0 cm and 5.5 cm, catheter lengths 180 cm and 240 cm, guidewire compatibility to 0.035".

Reference Part
Number		 Inflated Balloon
Diameter		 Balloon
Length		 Inflated
Pressure		 Catheter
Length		 Minimum Working
Channel		 Guidewire
Size
GDB-0110630S 6-7-8MM 3.0CM 3-6-10ATM 180CM 2.8MM 0.035"
GDB-0110655S 6-7-8MM 5.5CM 3-6-10ATM 180CM 2.8MM 0.035"
GDB-0110830S 8-9-10MM 3.0CM 3-5.5-9ATM 180CM 2.8MM 0.035"
GDB-0110855S 8-9-10MM 5.5CM 3-5.5-9ATM 180CM 2.8MM 0.035"
GDB-0111030S 10-11-12MM 3.0CM 3-5-8ATM 180CM 2.8MM 0.035"
GDB-0111055S 10-11-12MM 5.5CM 3-5-8ATM 180CM 2.8MM 0.035"
GDB-0111230S 12-13.5-15MM 3.0CM 3-4.5-8ATM 180CM 2.8MM 0.035"
GDB-0111255S 12-13.5-15MM 5.5CM 3-4.5-8ATM 180CM 2.8MM 0.035"
GDB-0111555S 15-16.5-18MM 5.5CM 3-4.5-7ATM 180CM 2.8MM 0.035"
GDB-0111855S 18-19-20MM 5.5CM 3-4.5-6ATM 180CM 3.2MM 0.035"
GDB-0120630S 6-7-8MM 3.0CM 3-6-10ATM 240CM 2.8MM 0.035"
GDB-0120655S 6-7-8MM 5.5CM 3-6-10ATM 240CM 2.8MM 0.035"
GDB-0120830S 8-9-10MM 3.0CM 3-5.5-9ATM 240CM 2.8MM 0.035"
GDB-0120855S 8-9-10MM 5.5CM 3-5.5-9ATM 240CM 2.8MM 0.035"
GDB-0121030S 10-11-12MM 3.0CM 3-5-8ATM 240CM 2.8MM 0.035"
GDB-0121055S 10-11-12MM 5.5CM 3-5-8ATM 240CM 2.8MM 0.035"
GDB-0121230S 12-13.5-15MM 3.0CM 3-4.5-8ATM 240CM 2.8MM 0.035"
GDB-0121255S 12-13.5-15MM 5.5CM 3-4.5-8ATM 240CM 2.8MM 0.035"
GDB-0121555S 15-16.5-18MM 5.5CM 3-4.5-7ATM 240CM 2.8MM 0.035"
GDB-0121855S 18-19-20MM 5.5CM 3-4.5-6ATM 240CM 3.2MM 0.035"

Through-the-Scope Dilatation in the GI Tract

A through-the-scope balloon — TTS in most endoscopy units — passes down the working channel of the endoscope and is inflated across the stricture under direct vision. The alternative, a wire-guided bougie or an over-the-wire balloon placed after scope withdrawal, means dilating something you can no longer see.

Direct vision is the whole argument for TTS. The endoscopist watches the waist form and release, sees mucosal response as it happens, and can stop at the first sign of a deep tear rather than discovering it on withdrawal. For a stricture that is tight, angulated, or close to a landmark that must not be dilated, that feedback is the difference between a controlled dilatation and a blind one.

The Amara™ catheter is built for that route: a high-column-strength shaft that transmits push through a long, angulated channel without buckling, and a balloon profile that passes a working channel of 2.8 mm or more. Technique and indications are covered in our clinical guide to navigating difficult anatomy in endoscopy.

Which Three-Stage Range to Order

Each Amara™ reference is a single balloon that reaches three diameters, selected by inflation pressure rather than by exchanging the device. A 10-11-12 mm balloon dilates to 10 mm at its first pressure step, 11 mm at the second and 12 mm at the third.

That changes how you order. Rather than selecting a target diameter, you are selecting the range a stricture is likely to need across one session or several — and the graduated approach that would otherwise require three catheters is available from one. Six ranges cover the spectrum:

  • •6-7-8 mm and 8-9-10 mm — tight strictures, first dilatation, or anatomy where a conservative endpoint is the plan
  • •10-11-12 mm and 12-13.5-15 mm — the usual working ranges for oesophageal stricture dilatation
  • •15-16.5-18 mm and 18-19-20 mm — larger-calibre targets where swallowing function rather than passage is the objective

Pressure steps scale with the range, from 3-4.5-6 ATM at the smallest to 3-6-10 ATM at the largest, and balloon lengths of 3.0 cm and 5.5 cm cover focal and longer segments. Twenty references in total — the full matrix is in the table above.

Endoscope Compatibility and Catheter Length

Two compatibility figures decide whether a reference will work with your scope, and both are in the sizing table.

Minimum working channel is 2.8 mm for the smaller balloons and 3.2 mm for the larger ones. A standard diagnostic gastroscope typically offers 2.8 mm, while therapeutic scopes and colonoscopes offer more — so the larger diameter ranges assume a therapeutic channel. Check the scope rather than the procedure name; channel size varies between models more than between indications.

Catheter length is 180 cm or 240 cm. The 180 cm references suit gastroscopy working lengths; 240 cm is for colonoscopes and enteroscopes, where a 180 cm catheter would not reach the stricture with enough shaft left outside the scope to handle. Ordering the shorter catheter for a colonoscopic indication is the most common avoidable mismatch.

All references are delivered over guidewires up to 0.035" and carry a radiopaque marker band for fluoroscopic confirmation where the stricture is not fully visible endoscopically.

Frequently Asked Questions

What is a multi-stage (3-stage) balloon dilator? +
A multi-stage balloon dilator is a single balloon dilatation catheter that reaches three distinct diameters at three separate inflation pressures. Because controlled radial expansion delivers each diameter in turn, one device completes a full progressive dilation of a stricture without exchanging catheters — reducing device count and procedure time compared with single-diameter balloons or serial bougie dilation.
What balloon diameter is used for an oesophageal stricture? +
Balloon choice follows the stricture diameter and the rule of three: dilate no more than 3 mm beyond the estimated luminal diameter in a single session. Tight strictures typically start at 6-7-8 mm; established peptic or anastomotic strictures are commonly treated at 12-13.5-15 mm or 15-16.5-18 mm; 18-19-20 mm is reserved for final-calibre dilation. Available sizes are 6-7-8, 8-9-10, 10-11-12, 12-13.5-15, 15-16.5-18 and 18-19-20 mm.
What working channel does a through-the-scope balloon dilator need? +
Sizes from 6-7-8 mm through 15-16.5-18 mm pass a standard 2.8 mm working channel. The 18-19-20 mm balloon requires a 3.2 mm therapeutic channel. All sizes are supplied in 180 cm and 240 cm catheter lengths for upper and lower GI access.
What inflation pressures does each stage require? +
Each balloon reaches its three diameters between 3 and 10 ATM, with the exact set depending on balloon size — for example 3-6-10 ATM for the 6-7-8 mm and 3-4.5-6 ATM for the 18-19-20 mm. High-pressure balloon material is designed to hold profile without waisting at the stricture. See the specifications table for the pressure set of each reference.
When do you use a wire-guided balloon dilator instead of a fixed-wire dilator? +
Use a fixed-wire (non wire-guided) dilator for straightforward through-the-scope dilations where the stricture can be crossed under direct vision. Choose a wire-guided balloon dilator when the stricture is tight, angulated or tortuous, when the lumen cannot be seen beyond the narrowing, or when fluoroscopic confirmation is needed — the guidewire secures access across the lesion before the balloon is advanced.
Is the balloon dilator sterile, single-use and CE-marked? +
Yes. The Multi-Stage Oesophageal Balloon Dilator (Amara™) is supplied sterile for single use, CE-marked under EU MDR 2017/745 and manufactured under ISO 13485.
Should I choose the 3.0 cm or the 5.5 cm balloon? +
The 3.0 cm balloon suits short, focal strictures, where precise placement across the narrowest point matters most. The 5.5 cm balloon covers longer segments and is less likely to slip out of the stricture during inflation, because more of the narrowed segment sits within its working length. The size table shows which lengths are offered for each diameter range and catheter length.
Why dilate through the scope rather than with a bougie? +
Because the stricture stays in view. A through-the-scope balloon inflates under direct vision: the endoscopist sees the waist form and yield, watches the mucosal response in real time and can stop at the first sign of a deep tear. Bougies, by contrast, are passed with the endoscope withdrawn, so the dilation itself is not seen.
Should I order the 180 cm or the 240 cm catheter? +
180 cm suits gastroscopy working lengths. 240 cm is for colonoscopes and enteroscopes, where a 180 cm catheter would not reach the stricture with enough shaft left outside the scope to handle. Ordering the shorter catheter for a colonoscopic indication is the most common avoidable mismatch.