Amara 3-Stage Balloon Dilator
Progressive Balloon Dilatation Catheter providing a consistent performance for balloon endoscopy with optimal control, efficiency and performance. Amara™ Progressive Balloon Dilatation Catheters are indicated for use in the removal of difficult biliary stones (DASE).
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.
Specifications
| 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 the Amara 3-Stage Balloon Dilator? +
A progressive balloon dilator for therapeutic endoscopy with three precise diameters per device, each reached at a specific inflation pressure. Indicated for oesophageal, pyloric, and other GI strictures requiring controlled progressive dilation.
What are the available balloon diameters? +
The Amara 3-Stage is available in diameter ranges of 6-8 mm, 8-10 mm, 10-12 mm, 12.5-15 mm, 15-18 mm, and 18-20 mm. The three stages within each device are reached at typical pressures of 6, 8, and 10 ATM. See the specifications table for the full reference list.
What endoscope channel size is required? +
The Amara 3-Stage is designed for through-the-scope (TTS) placement and is compatible with standard 2.8 mm working channels.
What is the difference between the Amara 3-Stage and the Amara Wireguided? +
The standard Amara 3-Stage is placed through the endoscope channel without a guidewire. The Amara Wireguided Balloon Dilator tracks over a guidewire for additional stability in tortuous or tight strictures.
Is it sterile single-use and CE-marked? +
Yes. The Amara 3-Stage Balloon Dilator is supplied sterile for single use, CE-marked under EU MDR 2017/745 and manufactured under ISO 13485.