Valvuloplasty catheter TRUE®

cardiacballoon

Features: Truly Precise – Accurate, reliable sizing Truly Fast – Designed to minimize rapid pacing times Truly Rupture Resistant – Engineered to avoid catastrophic failure INSTRUCTIONS FOR USE Description: The TRUE® DILATATION Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is available in110 cm and 55 cm lengths, and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.