Lacrosse NSE ALPHA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Nipro Australia Pty Ltd

Class:

Class III

Manufactured by:

Goodman Co Ltd Goodman Research Center 276-1 Idogane-cho, Seto, Aichi, 489-0976 Japan

Therapeutic area:

47732 - Angioplasty catheter, balloon dilatation, coronary, basic

Therapeutic indications:

The product is a rapid exchange (RX) semi-compliant balloon catheter with the protruding elements attached in order to decrease an occurrence of balloon slippage. This product has a hydrophilic coating applied to the surface. The purpose of the use of the product is to dilate atherosclerotic obstructed segments of coronary arteries that are difficult to dilate by regular POBA (plain old balloon angioplasty) to improve coronary artery flow. The device is intended to be used in vessels with a reference vessel diameter of 2.00?4.00 mm.

Authorization status:

A

Authorization date:

2019-09-06