Sterling Monorail PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Boston Scientific Pty Ltd

Class:

Class III

Manufactured by:

Boston Scientific Corporation 300 Boston Scientific Way, Marlborough, MA, 01752 United States Of America

Therapeutic area:

17184 - Catheter, angioplasty, balloon dilatation

Therapeutic indications:

The device is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014in or 0.018in to facilitate advancement of the catheter to and through the stenosis to be dilated. Indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid 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.

Authorization status:

A

Authorization date:

2007-04-24