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Spectranetics
AngioSculpt PTCA

AngioSculpt PTCA

Product catalog summary

Overview
The AngioSculpt® RX PTCA Scoring Balloon Catheter is designed for the treatment of complex coronary lesions, including in-stent restenosis (ISR) and type C lesions. It combines the advantages of the AngioSculpt system with a new tapered tip design for enhanced deliverability.

Key Features

Proper Placement: Rectangular scoring edges lock the device in place, minimizing slippage.
Mechanical Advantage: The device provides 15–25 times the force of conventional balloons, with a helical nitinol scoring element for large luminal expansion.
Predictable Results: Post-scoring forces are equivalent to conventional balloons, with a low dissection rate of 13.6%.
Improved Delivery: A new molded, tapered tip enhances catheter delivery and crossing ability.

Advanced Technology

Large working range (2 atm–20 atm) allows customization to vessel size.
Nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities.
Electropolished, helical scoring element for safe lesion scoring.
Rectangular edges ensure predictable dilation with low dissection rates.

Clinical Benefits

Pre-dilatation with AngioSculpt yields 33%–50% greater luminal gain compared to direct stenting or conventional balloons.
89% of vessels predilated with AngioSculpt had a final stent area ≥5.0 mm².

Indications and Contraindications

Indicated for treating significant coronary artery stenosis, including ISR and complex lesions.
Not suitable for coronary artery lesions unsuitable for percutaneous revascularization or coronary artery spasm without significant stenosis.

Warnings and Precautions

Administer appropriate antiplatelet and anticoagulant therapy during and after the procedure.
Device is for single use only; do not resterilize or reuse.
Use under high-quality fluoroscopic observation and do not exceed rated burst pressure during inflation.
PTCA should be performed at hospitals equipped for emergency coronary artery bypass surgery.

Possible Adverse Effects

Potential adverse effects include death, heart attack, coronary artery dissection, and other serious complications.

Ordering Information
Various catalog numbers are available with different balloon diameters and lengths, all compatible with a 0.014˝ guidewire and 6F guide catheter.

Catalog excerpts

Really Delivers Scoring Balloon Catheter

Open the catalog to page 1

AngioSculpt RX PTCA Scoring Balloon Catheter. ® Your Prescription For Complex Lesions. The AngioSculpt ® PTCA Scoring Balloon Catheter delivers the proven advantages of the AngioSculpt system combined with a new, tapered tip design that enhances deliverability. The result is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions. Discover The Benefits Precision Predictable Power ~1x force post scoring PROPER PLACEMENT ENHANCED MECHANICAL ADVANTAGE PREDICTABLE RESULTS – Rectangular scoring edges lock the device in place –...

Open the catalog to page 2

New Tip Designed For Improved Delivery You Can Trust The Delivery. The new AngioSculpt RX PTCA Scoring Balloon Catheter features an advanced molded, tapered tip that facilitates reliable catheter delivery. – Smooth transitions throughout the distal end of the catheter for improved crossing – The most agile and nimble AngioSculpt design ever – Elevates procedural confidence

Open the catalog to page 3

Advanced Technology Delivers Big Results. 1 arge working range L (2 atm–up to 20 atm) allows physician to tailor device to vessel size* balloon deflation for excellent rewrap and recross capabilities 3 Electropolished, helical scoring element safely scores lesion circumferentially4 provide a predictable dilatation resulting in low dissection rates and minimal device slippage1 * Please refer to AngioSculpt PTCA product labeling, including the instructions for use, to select the appropriate device size.

Open the catalog to page 4

Larger Luminal Gain. A New Dimension In Plaque Modification Post-stent luminal area is an important predictor of long-term outcome. Studies have shown that greater acute luminal gain is associated with better long-term results.5 – re-dilatation with AngioSculpt yielded 33% – 50% greater luminal gain than direct stenting P or pre-dilatation with a conventional angioplasty balloon3 – 9% of the vessels predilated with AngioSculpt had final stent area ≥5.0 mm2 compared 8 to 74% for direct stenting or pre-dilatation with a conventional balloon3 – he AngioSculpt group exhibited greater stent expansion...

Open the catalog to page 5

The AngioSculpt PTCA Scoring Balloon Catheter ® SUMMARY OF SAFETY AND EFFECTIVENESS — PTCA CATHETER Ordering Information Catalog Number Guidewire Compatibility Guide Catheter Compatibility The AngioSculpt Scoring Balloon Catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion. The AngioSculpt catheter should not be used for the following: Coronary artery lesions unsuitable for treatment by percutaneous revascularization. Coronary artery spasm...

Open the catalog to page 6

AngioSculpt PTCA

AngioSculpt PTCA

Catalog excerpts

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