TRUE® DILATATION
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TRUE® DILATATION - 1

Dilate Aortic Valves with Precision and Speed

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TRUE® DILATATION - 2

Truly Precise Truly Fast Inflation & Deflation The TRUE® DILATATION Balloon Valvuloplasty Catheter is true to size, exhibiting less than 1.0% stretch between 1 ATM and RBP.1 Designed to minimize rapid pacing times, the TRUE® DILATATION Balloon Valvuloplasty Catheter inflates and deflates in 5.6 seconds.2 Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results. Percentage stretch calculated using 22 mm balloons. N=10. Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests...

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TRUE® DILATATION - 3

Truly Rupture Resistant Truly Tight Re-Wrap The TRUE® DILATATION Balloon Valvuloplasty Catheter is engineered to avoid catastrophic failures and is highly resistant to ruptures, punctures, and tears.3 The TRUE® DILATATION Balloon Valvuloplasty Catheter is engineered to deliver a consistent, tight re-wrap providing a low withdrawal profile after dilatation. Bench data on file. Results may not necessarily be indicative of clinical performance. Different tests may yield different results. Fiber Based Technology Data for competitive balloons obtained from manufacturer IFUs. Data for TRUE® based...

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TRUE® DILATATION - 4

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...

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