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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.

Key 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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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.

Specifications

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"

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.