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AngioSculpt RX Taper Tip Brochure (International)

AngioSculpt RX Taper Tip Brochure (International)

AngioSculpt RX Taper Tip Brochure (International)

Product catalog summary
Overview: The AngioSculpt Scoring Balloon Catheter is an innovative medical device designed for the treatment of coronary artery disease. It features a flexible nitinol scoring element that works with a semi-compliant balloon to score lesions, providing precise and predictable outcomes.
Specifications: The catheter has a low crossing profile (~2.7F) and is compatible with 0.014” RX systems and 6F guiding catheters. It includes two radiopaque markers for precise placement and nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities.
Compliance Characteristics: The balloon's diameter varies with pressure, ensuring adaptability to different vessel sizes. The nominal pressure and rated burst pressure are critical parameters for safe operation.
Indications and Contraindications: The device is indicated for treating hemodynamically significant coronary artery stenosis, including in-stent restenosis. It should not be used for lesions unsuitable for percutaneous revascularization or in cases of coronary artery spasm without significant stenosis.
Warnings and Precautions: The device is intended for single use only. It should not be resterilized or reused. Balloon pressure should not exceed the rated burst pressure, and the procedure should be performed under high-quality fluoroscopic observation. The catheter should be used by trained physicians only.
Complications: Potential complications include heart attack, coronary artery dissection, emergency coronary artery bypass, and other serious conditions. Proper precautions and monitoring are essential to minimize risks.
Clinical Performance: The AngioSculpt has demonstrated a procedural success rate of 98.5% and is effective in treating complex lesions. It offers a significant luminal gain compared to conventional methods, with reduced dissection rates and no device slippage.
Ordering Information: The document provides detailed ordering information, including catalog numbers, balloon diameters, lengths, and compatibility details.
Conclusion: The AngioSculpt Scoring Balloon Catheter represents a significant advancement in the treatment of coronary artery disease, offering improved outcomes and versatility in complex lesion management.
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Catalog excerpts

AngioSculpt RX Taper Tip Brochure (International)-1

Innovation by design Technology that sets a new standard • lexible nitinol scoring element with three rectangular spiral F struts works in tandem with a semi-compliant balloon to score the target lesion • alloon inflation focuses uniform radial forces along B the edges of the nitinol element, scoring the plaque and resulting in a more precise and predictable outcome • ow crossing profile (~2.7F), 0.014” RX system compatible L with 6F guiding catheters • emi-compliant balloon material allows the physician to S tailor the device size to the vessel • wo radiopaque markers indicate the working T ends of the scoring balloon • itinol-enhanced balloon deflation for excellent N rewrap and recross capabilities Electropolished struts with rectangular edges provide a predictable dilatation.

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AngioSculpt RX Taper Tip Brochure (International)-2

The AngioSculpt Scoring Balloon Catheter SAFETY SUMMARY COMPLIANCE CHARACTERISTICS Balloon Diameter (mm) Nominal Pressure 18 Rated Burst Pressure ORDERING INFORMATION Catalog Number Guidewire Compatibility Guide Catheter Compatibility To learn more about the clinical advantages of the AngioSculpt Scoring Balloon Catheter, please contact your AngioScore distributor today. The AngioScore PTCA Scoring Balloon Catheter Rapid Exchange (RX) design is not commercially available in the USA. CE Mark Granted for Coronary and Peripheral Applications. © 2009 AngioScore, Inc. All Rights Reserved. INDICATIONS...

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AngioSculpt RX Taper Tip Brochure (International)-3

Changing the landscape of balloon angioplasty for coronary artery disease PTCA Scoring Balloon Catheter Rapid Exchange Delivery System

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AngioSculpt RX Taper Tip Brochure (International)-4

The AngioSculpt Scoring Balloon Catheter: A new dimension in patient outcomes The AngioSculpt Scoring Balloon Catheter transforms the landscape of treating coronary artery disease. It is an essential tool in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis (ISR), for the purpose of improving myocardial perfusion. When used for pre-dilatation prior to stenting, AngioSculpt has been proven to yield a 33%-50% greater luminal gain than either direct stenting or pre-dilatation with a conventional angioplasty balloon catheter.1 The innovative nitinol...

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AngioSculpt RX Taper Tip Brochure (International)-5

A new dimension in lesion preparation BETTER FINAL POST-STENT DIMENSIONS • re-dilatation with AngioSculpt resulted P in a post-stent luminal area ≥5.0 mm2 89% of the time, compared to only 74% with direct stenting or pre-dilatation with a conventional angioplasty balloon catheter (p<0.001)1 • ngioSculpt achieved larger post-stent A luminal dimensions than direct stenting or pre-dilatation with a conventional balloon regardless of the type of lesion plaque morphology (i.e., soft, fibrotic, calcific or mixed plaque)1 • re-dilatation with AngioSculpt yields P a 33%–50% greater luminal gain than...

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AngioSculpt RX Taper Tip Brochure (International)-6

A versatile tool for treating bifurcation lesions Pre-treatment: AngioSculpt placed at side branch in bifurcation lesion The clinical challenges common in bifurcation lesions—dissection, slippage and plaque shifting—can make a lengthy procedure even longer. AngioSculpt offers physicians an effective, time-saving tool for treating the unique challenges of bifurcation lesions. Post-treatment: AngioSculpt used as stand-alone treatment in side branch and pre-dilatation tool in main branch • o device slippage2 for precise and N predictable treatment of the target lesion • niform, radial, scoring forces...

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