Head & Neck | Airway Management | Stenosis

DilaTlaX® Balloon Dilation System for upper airways stenosis

An Airway Balloon Catheter with an integrated shaft system and a high-pressure airway balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the airway balloon with sterile water or saline. The inner lumen permits the use of the Airway Stylet to facilitate advancement of the balloon catheter to the target location, such as the trachea or upper bronchi. The luer at the proximal end is used for inflation and stylet access. The balloon is inflated by injecting sterile water or saline through the side port of the luer.

An Airway Stylet that is intended to facilitate the use of Airway Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.

Intended Use

The DILATLAX®Balloon Dilation System is an instrument intended to dilate strictures of the upper airway tree

BENEFITS

• Dilation of airway strictures with minimal mucosal trauma due to a pure radial expansile force without shear forces
• Faster procedure than serial dilation with bougies
• Balloons permit the surgeon to fine-tune the force applied using an inflation device that incorporate a pressure gauge
• Balloon may pass through severe stenosis and reach distal stenotic areas;
• Several size to better fit patient anatomy and physician indications
• Less chance of unintentional tissue/structure damage (e.g. vocal cords, mucosa) and reduced risk of scarring and continued inflammation
• Reduce the risk of restenosis

Features

• Low-profile, high pressure, non-compliant balloon
• Preloaded stylet for a faster and safer procedure
• Marker bands to ease balloon placement