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DIREX™

STEERABLE SHEATH

The DIREX Steerable Sheath’s low profile design and atraumatic tip are engineered to reduce the potential for trauma during transseptal crossings while facilitating passage of a wide variety of catheters. By combining a low profile, a braid reinforced shaft, and a reliable hemostatic seal technology, the DIREX Steerable Sheath offers physicians precise control during EP procedures.

11F 0.144"(3.67 mm) 13.2F 0.173"

(4.4 mm)0.117"

(2.97mm)8.9F

A variety of inner-lumen sizes

Proven BLAZER™ – like handling, exceptional delivery characteristics, and the most complete range of curve and delivery options for all your EP needs.

DIREX™ STEERABLE SHEATH

Now compatible with a wide variety of advanced catheters.Including ULTRA ICE™ and INTELLAMAP ORION™

ErgonomicSteering Handle

Soft Atraumatic Tip and Radiopaque

Marker Band

Two Sheath Side Holes

Smooth Tip-to-Dilator

Transition

HydrophilicCoated Sheath

Advanced Braided Shaft

Technology

The DIREX™ Steerable Sheath Features • Bidirectional steering allows dual deflection for maximum maneuverability

• Soft, atraumatic tip reduces potential for trauma during transseptal crossings and provides smooth transition to catheter

• Steerable sheath facilitates access to hard to reach sites

• Braided shaft provides exceptional torqueability, pushability and kink resistance

• Hemostatic Valve enables effective hemostasis, sealing down to a 0.014in guidewire

• Compatible with 0.038in/0.97mm guidewires

• Ergonomic handle allows precise control and more comfort

Curve Lock®

Reliable Hemostatic Seal

Soft Grip Handle

Curve Diameter and French Size Indicator

Distributed by:

Manufactured by Oscor Inc., 3816 DeSoto Blvd., Palm Harbor, FL 34683 USA, Phone (727) 937-2511

All trademarks are property of their respective owners.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Ordering InformationModel

NumberInner

DiameterSheath Length

Curve Dilator

M004 DS10 0 8.9F 71cm Small (17mm) 50º Curve

M004 DS10S 0 8.9F 71cm Small (17mm) Straight

M004 DS20 0 8.9F 71cm Medium (22mm) 50º Curve

M004 DS20S 0 8.9F 71cm Medium (22mm) Straight

M004 DS30 0 8.9F 71cm Large (50mm) 50º Curve

M004 DS30S 0 8.9F 71cm Large (50mm) Straight

M004 DS40 0 10F 67cm Medium (22mm) 50º Curve

M004 DS40S 0 10F 67cm Medium (22mm) Straight

M004 DS50 0 12F 67cm Large (50mm) 50º Curve

M004 DS50S 0 12F 67cm Large (50mm) Straight

DIREX™ Steerable Sheath

Rhythm Management300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com

Medical Professionals:1.800.CARDIAC (227.3422)Customer Service:1.888.272.1001

© 2016 by Boston Scientific Corporation or its affiliates. All rights reserved.

EP-235601-AD MAY2016

DIREX™ Steerable Sheath

INDICATIONS FOR USE The steerable sheath, model DiRex is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

CONTRAINDICATIONS Known active systemic or local infection. Known inability to obtain vascular access. Patients with atrial thrombus or myxoma, or interatrial baffle or patch. Use of a steerable sheath is contraindicated in patients with obstructed or inadequate vasculature.

PRECAUTIONS Transvenous device compatibility: Use the steerable sheath only with compatible transvenous devices. Use the appropriate size sheath for the size of the transvenous device being utilized. Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.

ADVERSE EVENTS Potential adverse effects related to the use of the steerable sheath include but are not limited to: Air Embolism, Allergic reaction to contrast media, Aortic puncture, Arrhythmias, Arteriovenous fistula formation, Atrial septal defect, Bleeding plexus injury, Catheter entrapment, Cardiac tamponade, Coronary artery spasm and/or damage, Dislodgement, Dissection, Endocarditis, Heart Block, Hematoma formation, Hemorrhage, Hemothorax, Infection, Intimal tear, Irregular heart beat, Local nerve damage, Mediastinal widening, Myocardial infarction, Pacemaker/defibrillator lead displacement, Perforation, Pericardial/pleural effusion, Pneumothorax, Pseudoaneurysm formation, Pulmonary edema, Stroke, Subclavian artery puncture, Thromboembolic events, Thrombophlebitis, Valve damage, Vascular occlusion, Vasovagal reaction, Vessel damage/Vessel trauma, Vessel spasm.