Device Dossier

Mustang Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for Mustang Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III,…

Intended purpose

Mustang is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. Balloons up to 120 mm in length are indicated for the treatment of biliary strictures.

Functional description

Mustang is compatible with 0.035 inch guidewires and has a dual lumen shaft ending in a Y-connector manifold with luer lock fittings. The manifold port marked “WIRE” is used to pass the catheter over 0.035 inch guidewires. The port marked “BALLOON” is used to inflate and deflate the balloon during the procedure. Two radiopaque marker bands, in conjunction with fluoroscopy, aid in placement of the balloon. A lubricious coating is applied from the distal tip to just proximal of the balloon.

TGA Public Summary