Wire-guided multi-stage balloon dilatation catheter over 0.035" guidewire (Amara™)

Wire-Guided Multi-Stage Balloon DilatorAmara™ Wireguided Balloon Dilatation Catheter · Over-the-Wire, 3-Stage

For strictures too tight or too angulated to cannulate directly. The wire-guided Amara™ tracks over a 0.035" guide wire to reach the lesion, then delivers three distinct diameters at three set pressures — oesophagus, pylorus, papilla or colon — without exchanging devices.

Wire-Guided Balloon Dilator Features

  • Over-the-wire delivery on guide wires up to 0.035", under direct visualisation or fluoroscopy, for strictures that cannot be crossed under vision alone.
  • Supplied with guidewire stylet, stopcock and clamp — wire access, inflation control and fixation in a single pack.
  • Radiopaque marker band to confirm balloon position across the stricture during fluoroscopy.
  • High column strength shaft for pushability and torque control when tracking through angulated or tortuous anatomy.
  • Controlled radial balloon expansion designed to produce 3 distinct and precise diameters at 3 separate pressures during dilatation.
  • High pressure balloon resistance designed to produce no balloon waisting.
  • Through-the-scope placement from a 2.8 mm working channel (3.2 mm for the 18-19-20 mm balloon), in 180 cm and 240 cm lengths.

Need a custom configuration or a private-label version? Explore our catheter design services, or see our ISO 13485 catheter manufacturing capabilities.

When to Choose Wire-Guided Over Fixed-Wire

Choose wire-guided when
  • The stricture is tight, angulated or tortuous and the balloon risks buckling without wire support.
  • The lumen beyond the narrowing cannot be seen, so the stricture cannot be crossed under direct vision.
  • Fluoroscopic confirmation of position is required before inflation.
  • Access across the lesion must be preserved between exchanges or across a multi-session dilation programme.
A fixed-wire dilator is sufficient when
  • The stricture is short, straight and can be crossed under direct endoscopic vision.
  • Fluoroscopy is not needed and the whole dilation is performed under vision.
  • Fewer components in the field and a simpler set-up are preferred for a routine dilation.

See the Multi-Stage Oesophageal Balloon Dilator (Amara™) — same balloon platform, same three diameters, without the guidewire accessories.

Wire-Guided Balloon Diameters and Accessories

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, guide wire compatibility to 0.035".

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

What the Stylet, Clamp and Stopcock Do

Every Amara™ wire-guided reference ships with three accessories, and each solves a specific problem in the wire-guided workflow rather than being a generic inclusion.

  • •Guidewire stylet — occupies the wire lumen during insertion, so the catheter tracks the channel with the stiffness of a fixed-wire device and the lumen stays patent until the wire is needed
  • •Clamp — fixes the guidewire relative to the catheter, so the wire does not migrate forward into the stricture or back out of position while the balloon is being advanced or inflated
  • •Stopcock — holds inflation pressure at a step without the operator maintaining force on the syringe, which is what makes a timed hold at a given diameter practical

Supplying all three in the pack matters more than it sounds: a wire-guided dilatation improvised with whatever clamp and stopcock are on the trolley is where wire position tends to be lost.

Keeping Wire Access Through an Exchange

The reason to run over a wire is not the dilatation itself — it is everything that might follow it. Once a guidewire is across a tight or angulated stricture, that wire is the hard-won part of the procedure. A fixed-wire balloon withdrawn from the channel takes its access with it; a wire-guided balloon leaves the wire in place.

That matters when the first balloon range turns out to be wrong, when a stricture needs a second device, or when dilatation is followed by stent placement through the same track. Each exchange over a retained wire costs a catheter swap; each exchange without one costs re-cannulating a stricture that has just been dilated and may now bleed or be oedematous.

The trade-off is that wire-guided placement is a slightly longer set-up, which is why both options exist — the Oesophageal Balloon Dilator (Amara™) remains the more direct choice for a straightforward stricture seen clearly on the scope.

Matching the Reference to Your Endoscope

Twenty references span six three-stage diameter ranges, from 6-7-8 mm to 18-19-20 mm, in balloon lengths of 3.0 cm and 5.5 cm. Two figures determine which will physically work with your scope.

Minimum working channel is 2.8 mm for the smaller ranges and 3.2 mm for the larger. Catheter length is 180 cm for gastroscopy or 240 cm for colonoscopes and enteroscopes. A wire-guided device makes the length question slightly more pointed than it is for a fixed-wire balloon, because the guidewire has to be long enough to retain access while the catheter is withdrawn over it — a short wire with a long catheter leaves nothing to hold.

Guidewire compatibility is up to 0.035" across the range, and each reference carries a radiopaque marker band for fluoroscopic confirmation where the stricture cannot be fully seen endoscopically.

Frequently Asked Questions

When do you use a wire-guided balloon dilator instead of a fixed-wire dilator? +
Choose a wire-guided balloon dilator when the stricture is tight, angulated or tortuous, when the lumen beyond the narrowing cannot be seen, or when fluoroscopic confirmation is required — the guide wire is placed across the lesion first and secures access before the balloon is advanced, which reduces buckling and loss of position. A fixed-wire multi-stage balloon dilator is sufficient for straightforward through-the-scope dilations where the stricture can be crossed under direct vision.
What guidewire size does a wire-guided balloon dilator take? +
It accepts standard endoscopy guide wires up to 0.035". Pre-loading the guide wire across the stricture before advancing the balloon improves trackability and reduces buckling in angulated anatomy. A guidewire stylet, stopcock and clamp are supplied with the device.
What balloon diameters and catheter lengths are available? +
Balloon sizes are 6-7-8, 8-9-10, 10-11-12, 12-13.5-15, 15-16.5-18 and 18-19-20 mm, in 3.0 cm and 5.5 cm balloon lengths. Catheter working lengths of 180 cm and 240 cm cover upper and lower GI access. Each balloon reaches its three diameters between 3 and 10 ATM depending on size — see the specifications table for the pressure set of each reference.
What working channel does a wire-guided TTS 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.
Is the wire-guided dilator CE-marked, MDR-compliant and single-use sterile? +
Yes. The Wire-Guided Multi-Stage Balloon Dilator (Amara™) is CE-marked under EU MDR 2017/745, manufactured under ISO 13485, and supplied sterile for single use with guidewire stylet, stopcock and clamp included.
What accessories are supplied with the wire-guided balloon? +
A guidewire stylet, a clamp and a stopcock. The stylet occupies the wire lumen during insertion so the catheter tracks with the stiffness of a fixed-wire device; the clamp fixes the wire relative to the catheter so it cannot migrate during advancement or inflation; the stopcock holds inflation pressure at a step without the operator maintaining force on the syringe.
How long does the guidewire need to be? +
Long enough to retain access while the catheter is withdrawn over it. This matters more for a wire-guided device than a fixed-wire one: pair a short wire with a 240 cm catheter and there is nothing left to hold when you come to exchange, which defeats the reason for running over a wire at all.
Is the balloon itself the same as the standard Amara™ dilator? +
The balloon platform is the same — the same six three-stage diameter ranges from 6-7-8 mm to 18-19-20 mm, the same 3.0 cm and 5.5 cm lengths, the same 2.8 mm or 3.2 mm minimum working channel and 180 cm or 240 cm catheter options. The difference is the wire lumen and the accessories that make wire-guided placement and exchange practical.