Amara Wireguided 3-Stage Balloon Dilator
Progressive Balloon Dilatation Catheter providing a consistent performance for balloon endoscopy with optimal control, efficiency and performance. Amara™ Wireguided 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.
- Delivered with the guidewire stylet, stopcock and clamp to facilitate the procedure.
Specifications
| Reference Part Number |
Inflated Balloon Diameter |
Balloon Length |
Inflated Pressure |
Catheter Length |
Minimum Working Channel |
Guidewire Size |
Accessories Supplied |
|---|---|---|---|---|---|---|---|
| GDB-0210630S | 6-7-8MM | 3.0CM | 3-6-10ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0210655S | 6-7-8MM | 5.5CM | 3-6-10ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0210830S | 8-9-10MM | 3.0CM | 3-5.5-9ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0210855S | 8-9-10MM | 5.5CM | 3-5.5-9ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211030S | 10-11-12MM | 3.0CM | 3-5-8ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211055S | 10-11-12MM | 5.5CM | 3-5-8ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211230S | 12-13.5-15MM | 3.0CM | 3-4.5-8ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211255S | 12-13.5-15MM | 5.5CM | 3-4.5-8ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211555S | 15-16.5-18MM | 5.5CM | 3-4.5-7ATM | 180CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0211855S | 18-19-20MM | 5.5CM | 3-4.5-6ATM | 180CM | 3.2MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0220630S | 6-7-8MM | 3.0CM | 3-6-10ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0220655S | 6-7-8MM | 5.5CM | 3-6-10ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0220830S | 8-9-10MM | 3.0CM | 3-5.5-9ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0220855S | 8-9-10MM | 5.5CM | 3-5.5-9ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221030S | 10-11-12MM | 3.0CM | 3-5-8ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221055S | 10-11-12MM | 5.5CM | 3-5-8ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221230S | 12-13.5-15MM | 3.0CM | 3-4.5-8ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221255S | 12-13.5-15MM | 5.5CM | 3-4.5-8ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221555S | 15-16.5-18MM | 5.5CM | 3-4.5-7ATM | 240CM | 2.8MM | 0.035" | Stylet, Clamp, Stopcock |
| GDB-0221855S | 18-19-20MM | 5.5CM | 3-4.5-6ATM | 240CM | 3.2MM | 0.035" | Stylet, Clamp, Stopcock |
Frequently Asked Questions
When should I use the wireguided version vs. the standard Amara? +
The wireguided Amara is preferred in tight, tortuous, or angled strictures where guidewire support improves tracking and balloon stability. The standard Amara 3-Stage is sufficient for most straightforward through-the-scope dilations.
What guidewire is compatible? +
The Amara Wireguided accepts standard 0.035" endoscopy guidewires. Pre-loading the wire across the stricture before balloon insertion improves trackability and reduces buckling.
What balloon diameters are available? +
The Amara Wireguided is available in the same diameter ranges as the standard Amara: 6-8 mm, 8-10, 10-12, 12-15, 15-18, and 18-20 mm. Three stages per device at typical 6, 8, and 10 ATM inflation pressures.
What is the catheter working length? +
The Amara Wireguided is available in working lengths of 180 cm and 240 cm to cover both upper and lower GI applications.
Is it MDR-compliant? +
Yes. The Amara Wireguided Balloon Dilator is CE-marked under EU MDR 2017/745, manufactured under ISO 13485, and supplied sterile for single use.