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TRUE® DILATATION

TRUE® DILATATION

TRUE® DILATATION

Product catalog summary
Overview: The document provides detailed information about the TRUE® DILATATION Balloon Valvuloplasty Catheter, highlighting its design, specifications, and usage instructions. It emphasizes the catheter's precision, speed, and safety features.
Specifications: The catheter is designed for rapid inflation and deflation, completing the process in 5.6 seconds. It offers predictable sizing with less than 1.0% stretch between 1 ATM and RBP, ensuring precise measurements. The catheter is available in 110 cm and 55 cm lengths, with a balloon fixed at the tip.
Design Features: The catheter is engineered for a tight re-wrap, providing a low withdrawal profile. It is highly resistant to ruptures, punctures, and tears, minimizing the risk of catastrophic failures.
Instructions for Use: The catheter is an over-the-wire co-axial device with two lumens for balloon inflation and guidewire positioning. It includes radiopaque marker bands for accurate positioning across the aortic valve. The device is sterilized with ethylene oxide gas and should be stored in a cool, dry place.
Indications and Contraindications: The catheter is indicated for balloon aortic valvuloplasty but contraindicated for patients with annular dimensions less than 18 mm.
Potential Complications: Possible complications include allergic reactions, cardiovascular injury, embolization, and infection, among others.
Warnings and Precautions: The device is for single use only and should not be re-sterilized. Proper sizing and high-quality fluoroscopic observation are critical during use. The catheter should not be used if damaged, and specific guidelines for inflation and withdrawal must be followed to prevent complications.
Safety Information: Detailed safety information and instructions for use are provided in the package insert. The catheter should only be used by trained physicians.
Contact Information: For more information, users are directed to contact Bard Peripheral Vascular, Inc. or visit their website.
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Catalog excerpts

TRUE® DILATATION-1

Dilate Aortic Valves with Precision and Speed

 Open the catalog to page 1
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 may...

 Open the catalog to page 2
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 on...

 Open the catalog to page 3
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 designed...

 Open the catalog to page 4

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