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CTO-Family

Product catalog summary

Introduction
The document provides an overview of the CROSSER® CTO Recanalization System, a medical device designed for crossing chronic total occlusions (CTOs) in peripheral arteries through atherectomy. It outlines the challenges associated with CTO procedures and the benefits of using the CROSSER® system.

Anatomy of a CTO
CTO crossing involves navigating three key segments: the Proximal Cap, Mid-Occlusion, and Distal Cap. The CROSSER® system enhances steerability and efficiency in crossing these segments.

Clinical Study and Success Rates
The PATRIOT Clinical Study reported an 83.5% success rate in complete lesion crossing using the CROSSER® system, significantly higher than the 5-66% success rate with conventional guidewire techniques. The study also noted zero CROSSER® related clinical perforations.

Challenges in CTO Procedures
Common failures in CTO procedures include difficulty in penetrating the proximal cap, navigating side branches, and re-entering the distal true lumen, leading to prolonged procedures, increased radiation exposure, and potential need for repeat interventions.

Device Features and Efficiency
The CROSSER® 14S Catheter is optimized for central lumen crossing, particularly in highly calcified lesions. The CROSSER® S6 Catheter uses vibrational energy for enhanced efficiency and is flexible for use in small and tortuous vessels.

Support Catheter Features
The SIDEKICK® Support Catheter offers improved steerability with an angled tip, while the PORTER® Guidewire provides precise steerability with varying tip stiffness. The SEEKER® Crossing Support Catheter combines optimal pushability with a low tip entry profile.

GeoAlign® Marking System
This system simplifies intravascular measurement, enhances procedure efficiency, and reduces radiation exposure by minimizing fluoroscopy time.

Warnings and Precautions
The document emphasizes the importance of proper training, device inspection for damage, and using refrigerated saline for irrigation. It warns against device reuse and outlines potential adverse events.

Ordering Information
Details are provided for ordering components of the CROSSER® system, including catheters, generators, and support devices.

Conclusion
The CROSSER® CTO Recanalization System significantly improves crossing success rates for CTO procedures, focusing on efficiency and safety. Proper training and adherence to guidelines are crucial for optimal use.

CROSSER® Recanalization System

Ensure proper irrigation before activation and limit activation time to 5 minutes to prevent malfunction.
Position equipment to avoid tripping hazards and ensure the generator is securely mounted.
Maintain a safe distance from patients and ensure unobstructed ventilation.

FLOWMATE® Injector

Designed for sterile saline injection as an accessory to the CROSSER® System.
Inspect for damage before use and ensure proper grounding.
Avoid use with contrast media or flammable anesthetics.
Follow proper syringe loading techniques to minimize air embolism risk.

PORTER® Guidewire

Intended for coronary and peripheral vasculature, not for cerebral use.
Monitor guidewire manipulation under fluoroscopy to avoid complications.

SEEKER® Crossing Support Catheter

Used for guidewire exchange and infusion in the peripheral vascular system.
Single-use only; do not reuse or resterilize.
Handle with care to avoid catheter damage or separation.

SIDEKICK® and USHER® Support Catheters

Single lumen catheters for creating pathways in peripheral vasculature.
Not for use with cutting/scoring balloons or in pediatric/neonatal patients.
Inspect for damage before use and ensure compatibility with other devices.

General Warnings and Precautions

All devices are single-use and should not be reused or resterilized to prevent contamination and infection risks.
Proper training and adherence to instructions are crucial for safe and effective use.
Dispose of used devices according to medical and legal regulations.

Catalog excerpts

Advancing Lives and the Delivery of Health Care™

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Anatomy of a CTO CTO Crossing involves passage of three segments: · Proximal Cap · Mid-Occlusion SIDEKICK® SUPPORT CATHETER CROSSER® CTO RECANALIZATION CATHETER HIDDEN COLLATERAL CALCIFIC PLANE ANGLED TIP OF SUPPORT CATHETER ALLOWS FOR IMPROVED STEERABILITY TOWARDS FLUSH OCCLUSIONS OR LESIONS ON AN ANGLE

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Challenges of a CTO · CTO procedure failures are primarily due to the inability to:1 LENGTHY PROCEDURES RADIATION EXPOSURE PERIPROCEDURAL COMPLICATIONS REPEAT INTERVENTION · Navigate side branches · Re-enter distal true lumen · Failure to cross lesions, with possible procedure failure, may lead to important burdens such as lengthy procedures, increased radiation exposure, periprocedural complications, and repeat intervention2,3 · Clinical literature has shown CTO crossing success rates of 5% to 66% with primary wire-catheter1 · This may result in sub-intimal deflection and subsequent dissection...

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The Workhorse 5F Catheter The CROSSER® 14S Catheter is a frontline therapy that enables central lumen crossing and maximizes therapeutic options for CTO recanalization via atherectomy. Focused Efficiency for Highly Calcified Lesions The small CROSSER® S6 Catheter tip focuses vibrational energy providing greater efficiency. The flexible design of the CROSSER® S6 Catheter facilitates deliverability to small and tortuous vessels. CROSS CHALLENGING LESIONS VIA ATHERECTOMY

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Capital Equipment Generator The reusable, 21kHz CROSSER® Generator converts AC power into high frequency current. Piezoelectric crystals within the transducer convert high frequency current into vibrational energy. The physician controls the procedure and pace of the CROSSER® Generator and FLOWMATE® Injector with a single foot switch. Injector The performance of the CROSSER® Catheter is optimized by precise activation and saline delivery. The integrated saline injector has pre-set settings for a flow rate of 18ml/min and can be operated by one person for added convenience. 150 ML STERILE DISPOSABLE...

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Disposable Devices Support Catheter Features • Stainless steel, braided shaft construction enables greater push and torquability* STRAIGHT TAPERED ANGLED TAPERED • Angled tip allows for improved steerability towards flush occlusions or lesions on an angle More Options The various tip stiffness levels of the PORTER® Delivery Guidewire provide precise steerability with 1:1 torque transmission. The unique hydrophilic coating of the PORTER® Guidewire provides enhanced trackability in tortuous anatomy. The SEEKER® Crossing Support Catheter expands treatment possibilities by combining optimal pushability...

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Enhance Your Procedure with the GeoAlign® Marking System The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. These markings are designed for simplified length measurement between two intravascular points. During repeat catheter placement, the GeoAlign® Marking System is designed to help increase procedure efficiency and reduce radiation exposure by minimizing fluoroscopy time. DISTANCE FROM THE DISTAL TIP OF CATHETER MARKER BANDS DENOTED EVERY 1 CM CROSSER + GeoAlign CTO Recanalization System Marking System ® INTRAVASCULAR MEASUREMENT PROCEDURE...

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Ordering Information Catheters & Capital Equipment Adjunctive Devices CROSSER® CTO Recanalization Catheters Description Length (cm) Platform RX 106 ® OTW CROSSER Catheter 14S RX 146 OTW 106 no wire CROSSER® Catheter S6 154 no wire CROSSER® Generator / FLOWMATE® Injector Description ® CROSSER Generator FLOWMATE® Injector FLOWMATE® Procedural Kit (5/box) Product Code GEN200 INJ100 INJKIT SIDEKICK® Support Catheters Length (cm) Shape Straight Straight Tapered 70 Angled Angled Tapered Straight Straight Tapered 110 Angled Angled Tapered FLOWMATE® Injector is intended for use with the CROSSER® Generator...

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CROSSER® CTO Recanalization Catheter Indications: The C ROSSER® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The C ROSSER® Catheter is only intended for use with the C ROSSER® Generator. Refer to the C ROSSER® Generator Manual of Operations for proper use. Contraindications: The device is contraindicated for use in carotid arteries. Warnings and Precautions: 1) The C ROSSER® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty...

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Bard, Advancing Lives and the Delivery of Health Care, Crosser, Flowmate, GeoAlign, Porter, Seeker, Sidekick and Usher are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. Copyright © 2017, C. R. Bard, Inc. All Rights Reserved. Illustrations by Mike Austin. Copyright © 2017. All Rights Reserved. Bard Peripheral Vascular Inc. | 1 800 321 4254 | www.bardpv.com | 1625 W. 3rd Street Tempe, AZ 85281 BPV/CTTO/0416/0010(1)

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CTO-Family

CTO-Family

Catalog excerpts

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