ACCESS. GUIDING. DIAGNOSTIC. PRODUCT PORTFOLIO Oscor Inc. designs, develops, manufactures and markets a variety of highly specialized diagnostic devices including catheters, introducer kits, fixed-curve guide sheaths and steerable guide sheaths used to facilitate vascular access for your interventional cardiology, electrophysiology, radiology, vascular surgery, oncology and peripheral needs. Oscor’s wide variety of product lines also include temporary external pacemakers, temporary pacing leads and temporary heartwires, implantable lead adaptors, pacing accessories, custom products and more. Oscor sells its products world-wide through a combination of direct sales efforts and authorized distributors. Oscor is also a proud supplier to the leading medical device companies on an Original Equipment Manufacturer (OEM) basis. SOLUTIONS CRM / Electrophysiology Interventional Cardiology Interventional Radiology Cardiac Surgery PRODUCTS Introducers Peel Away Sheath Peel Away Sheath with Valve Valved Access Sheath Radial Access Sheath Large Access Sheath 6 8 12 16 18 Guiding Sheaths Fixed Sheath Deflectable Sheaths 20 24 Angiography Catheters 30 Venography Catheters 32 External Pacemakers 34 Temporary Pacing Leads Transvenous Pacing Balloon Flow Directed 36 38 Myocardial Heart Wires 40 Connection Cables 42 Implantable Lead Adaptors 44 Accessories 46 Hospital Equipment 52 Medical OEM Solutions 54 INTRODUCERS Adelante® Peel-Away Introducer The Adelante® peel away introducer system is one of the most advanced introducers available for placement of permanent pacing leads and catheters. It offers exceptional insertion, smooth lead movement, high kink resistance and exceptional peeling performance even in complex conditions. Sheath ID Sizes: 6 F to 12.5 F Sheath Lengths: 16, 23, 30 or 45 cm Dilator Lengths: 19, 26, 34 or 49 cm Accepts Maximum Guidewire: 0.038 in Packaging available in: • Sheath, dilator and accessories Dilator tip indicator French size color coding Ergonomic handles Consistent peel • Sheath and dilator only • Bulk non-sterile Hydrophobic coated sheath Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 6 | www.oscor.com Product Portfolio | 7 INTRODUCERS Adelante® SafeSheath Ultra Lite Peel Away Sheath with Valve ® ® The Adelante SafeSheath Ultra Lite Peel Away Introducer System, features a speciallly engineered valve membrane that allows for reduced forces during insertion. Sheath ID Sizes: 5 F to 16.5 F Sheath Lengths: 13 cm Dilator Lengths: 18 cm Accepts Maximum Guidewire: 0.038 in Packaging available in: • Sheath, dilator and accessories Screw-locking dilator connector Color coded introducer cap / hemostatic valve Consistently clean and smooth peel • Sheath and dilator only • Bulk non-sterile * SafeSheath is a registered trademark of Pressure Products, Inc. Hydrophobic coated sheath with extruded score line Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 8 | www.oscor.com Product Portfolio | 9 INTRODUCERS Adelante® SafeSheath II Peel Away Sheath with Valve Lubricated hemostatic valve The Adelante® SafeSheath® II is the next generation hemostatic peel away introducer for vascular access. Featuring the latest lubricated hemostatic valve membrane that provides low insertion forces during procedures. It also includes a sideport with a 3-way stopcock for aspirating and flushing the introducer. Sheath ID Sizes: 6 F to 12.5 F Sheath Lengths: 13 or 23 cm Dilator Lengths: 19.5 or 29.5 cm Accepts Maximum Guidewire: 0.038 in Packaging available in: • Sheath, dilator and accessories Snap-locking dilator cap with French size indicator Ergonomic, easy splitting hub with color-coded cap Hydrophobic coated sheath * SafeSheath is a registered trademark of Pressure Products, Inc. 3-way stopcock Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 10 | www.oscor.com Product Portfolio | 11 INTRODUCERS Adelante® Sigma Valved Access Sheath The Adelante® Sigma is the next generation in vascular access sheath introducers, featuring the latest hemostatic valve technology, which allows for the introduction of small to large devices. Snap-locking dilator connector French size and guidewire indicator Sheath ID Sizes: 4 F to 12 F Sheath Lengths: 10 or 23 cm Dilator Lengths: 15 or 28 cm Accepts Maximum Guidewire: 0.038 in Packaging available in: Reliable hemostatic seal • Sheath, dilator and accessories • Sheath, dilator and guidewire only • Sheath and dilator only • Bulk non-sterile Kink resistant, flexible, and hydrophobic coated sheath Color coded side port and 3-way stopcock Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 12 | www.oscor.com Product Portfolio | 13 INTRODUCERS Adelante® Sigma Plus Valved Access Sheath with Luer Connect The Adelante Sigma Plus is latest in vascular access sheath introducers, featuring hemostatic valve technology, and a special luer locking design, that allows easy and secure accessory connection. (e.g. contamination guard) ® Sheath ID Sizes: 4 F to 8 F Sheath Lengths: 10 or 23 cm Dilator Lengths: 15 or 28 cm Accepts Maximum Guidewire: 0.038 in Dilator and sheath in locked position Reliable hemostatic seal Luer connect mechanism Packaging available in: • Sheath, dilator and accessories • Sheath and dilator only • Bulk non-sterile Kink resistant, flexible, and hydrophobic coated sheath Smooth dilator/ sheath transition Smooth guidewire/ dilator transition Direct easy and secure contamination guard connection (80 cm when fully extended) Contamination guard available as an accessory, Model No: CG8580 (20 per box) 14 | www.oscor.com Product Portfolio | 15 INTRODUCERS Adelante® Radial Radial Access Sheath Snap-locking dilator connector The Adelante® Radial is a high performance hydrophilic coated introducer sheath system optimized for radial access, featuring the latest in hemostatic valve technology for minimal blood loss during guidewire manipulation, diagnostic angiography and percutaneous coronary intervention. The Adelante® Radial features a low profile kink-resistant and hydrophilic coated sheath for smooth and atraumatic insertion and removal of the device. The Adelante® Radial represents the latest and newest in low profile introducer sheath technology. Reliable SureSeal™ hemostatic valve French size and guidewire indicator Sheath ID Sizes: 4 F, 5 F or 6 F Sheath Lengths: 7, 10 or 25 cm Dilator Lengths: 12, 15 or 30 cm Accepts Maximum Guidewire: 0.021 in EnSilk™ hydrophilic coating technology Packaging available in: STARTER KIT: • Sheath & Dilator WIRE KIT: • Sheath, Dilator and Stainless Steel Guidewire SS KIT: • Sheath, Dilator, Stainless Steel Guidewire, Needle and Syringe ELITE KIT: • Sheath, Dilator, Plastic Jacket Nitinol Guidewire, IV Catheter and Syringe 16 | www.oscor.com Elongated dilator to sheath transition for easy access Smooth guidewire/ dilator transition Product Portfolio | 17 INTRODUCERS Adelante® Magnum Large Access Sheath The Adelante® Magnum is a high performance hemostatic valve introducer for large size vascular access. The Adelante® Magnum features a proprietary multilayer hydrophilic coated sheath, having a special designed distal tip portion to accept and tolerate the insertion and manipulation of large and complex devices. The Adelante® Magnum SureSeal™ technology facilitates optimum hemostasis, allowing the insertion of multiple catheters and wires simultaneously with minimal blood loss. Sheath ID Sizes: 16 F and 18 F Sheath Lengths: 20, 30 or 35 cm Dilator Lenghts: 25, 35 or 40 cm Accepts Maximum Guidewire: 0.038 in Dilator with French size and guidewire indicator Color coded hub with SureSeal™ hemostatic valve Multi-layer sheath with EnSilk™ hydrophilic coating technology Depth markings for easy identification and placement Packaging available in: • Sheath and dilator only • Bulk non-sterile Reinforced atraumatic distal tip with marker band Smooth sheath to dilator transition Smooth dilator to guidewire transition 18 | www.oscor.com Product Portfolio | 19 GUIDING SHEATHS Adelante® Breezeway Fixed Guiding Sheath (EP) The Adelante® Breezeway® guiding sheath is intended for the percutaneous introduction of various types of cardiovascular catheters to all chambers of the heart, including transseptal puncture. The Adelante® Breezeway® features a proprietary braided Flexsteer™ hydrophobic coated sheath and the latest SureSeal™ technology. Sheath ID Sizes: 8 F and 10 F Sheath Lengths: 61 or 79 cm Dilator Lengths: 66 or 84 cm Accepts Maximum Guidewire: 0.035 in Reliable SureSeal™ hemostatic valve Snap-locking dilator connector Advanced Flexsteer™ braided shaft technology Packaging available in: Hydrophobic coated sheath • Sheath and dilator only • Bulk non-sterile Straight 55˚ Soft atraumatic radiopaque tip 70˚ Two side holes 90˚ 120˚ Available in different curves Smooth sheath / dilator transition (Custom curve configurations available upon request) 20 | www.oscor.com Product Portfolio | 21 GUIDING SHEATHS Adelante® Breezeway Fixed Guiding Sheath (Interventional) The Adelante® Breezeway® is a high performance delivery sheath, optimized for the introduction of diagnostic and therapeutic devices into the human vasculature, including intercardiac, renal or other placements. The Adelante® Breezeway® features a proprietary braided Flexsteer™ hydrophilic coated sheath and the latest SureSeal™ technology. Reliable SureSeal™ hemostatic valve Snap-locking dilator connector Sheath ID Sizes: 6 F, 7 F, or 8 F Sheath Lengths: 45, or 55 cm Dilator Lengths: 50, or 60 cm Accepts Maximum Guidewire: 0.035 in Packaging available in: Braided Flexsteer™ shaft technology • Sheath and dilator only • Bulk non-sterile EnSilk™ hydrophilic coating technology MP Curve RDC Curve TD Curve Soft atraumatic radiopaque tip LIMA Curve Available in different curves Smooth sheath to dilator transition (Custom curve configurations available upon request) 22 | www.oscor.com Product Portfolio | 23 GUIDING SHEATH Destino™ Twist Deflectable Steerable Guiding Sheath The Destino™ Twist is a steerable guiding sheath that offers a deflectable tip with an ergonomic handle. The Destino™ Twist is the ultimate tool for gaining access to the most difficult to reach sites, while maintaining hemostasis with Oscor SureSeal™ technology. The Destino™ Twist is your one sheath solution intended to facilitate the intracardiac, renal, and peripheral placements of diagnostic and therapeutic devices. Sheath ID Sizes: 6.5 F, 7 F, 8.5 F, 12 F, 13.5 F Sheath Lengths: 45, 55, 65, 67, 71, 73, 75 or 90 cm Dilator Lengths: 63, 73, 83, 85, 89, 91, 93 or 108 cm Curve Sizes: 9, 17, 22, 30, 39, or 50 mm Accepts Maximum Guidewire: 0.038 in Clear view of the distal marker band under fluoroscopy Smooth tip to dilator transition Advanced Flexsteer™ braided shaft technology Hydrophobic coated sheath Packaging available in: • Sheath and dilator only Rotating collar Tip position indicator Ticha Damascelli (TD) Curve Reliable SureSeal™ hemostatic valve Straight Available in different curves French size and guidewire indicator (Custom curve configurations available upon request) 24 | www.oscor.com Product Portfolio | 25 GUIDING SHEATHS Destino™ Bi-Directional Steerable Guiding Sheath The Destino™ is a next generation bi-directional steerable guiding sheath for the introduction and placement of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, transseptal, and other placements. Featuring a next generation hemostatic valve and braided FlexSteer® Shaft Technology, the Destino™ is the only available steerable sheath with true bidirectional tip deflections of 180˚. Sheath ID Sizes: 8.5 F, 10 F, and Sheath Lengths: 61, 67 or 71 cm Dilator Lengths: 85, 90 or 94 cm Curve Sizes: 17, 22, or 50 mm Accepts Maximum Guidewire: 0.038 in Dilator also available in 50˚ curve Bi-directional deflection 180°/ 180° Soft atraumatic tip,radiopaque marker band with two side holes Advanced Flexsteer™ braided shaft technology Hydrophobic coated sheath 12 F Easy locking ergonomic steering handle with curve, length & french size indicator Packaging available in: • Kit with accessories Reliable SureSeal™ hemostatic valve • Sheath, dilator, and guidewire set • Sheath and dilator only Depth markings 50 mm 22 mm 17 mm French size and guidewire indicator Bi-directional curve sizes 26 | www.oscor.com Product Portfolio | 27 GUIDING SHEATHS Destino™ Reach Bi-Directional Deflectable Guiding Sheath 50˚ curve dilator Bi-directional deflection 180°/ 180° Clear view of the distal marker band under fluoroscopy The Destino™ Reach is the next generation bidirectional steerable guiding sheath, featuring precise deflection, exceptional support and a low profile that provides ease of access. The Destino™ Reach is the ultimate tool for gaining access to the most difficult to reach sites, while maintaining hemostasis with Oscor SureSeal™ technology. The Destino™ Reach is intended for the introduction and placement of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, transseptal, and other placements. Sheath ID Sizes: 8.5 F, 10 F, and 12 F Sheath Lengths: 67, 71, 73, 75, or 77 cm Dilator Lengths: 85, 89, 90, 93 or 94 cm Curve Sizes: 17, 22, or 50 mm Accepts Maximum Guidewire: 0.038 in Packaging available in: Smooth tip to dilator transition. Sheath tip with two side holes Hydrophobic coated sheath Braided Flexsteer™ shaft technology Rotating collar Tip position indicator • Sheath and dilator only Reliable SureSeal™ hemostatic valve 50 mm 22 mm 17 mm Depth markings for easy identification and placement Bi-directional curve sizes 28 | www.oscor.com Product Portfolio | 29 ANGIOGRAPHY CATHETERS Angios® Diagnostic Angiographic Catheter Color coded The Angios diagnostic catheters features a proprietary HD braid reinforced shaft offering easy advancement while retaining excellent curve stability, maximum flow rate during contrast injection, and an ultra soft radiopaque catheter tip to minimize vessel trauma. ® Pigtail tip straightener ID Sizes: 4 F, 5 F, and 6 F Lengths: 100, 110, or 120 cm Accepts Maximum Guidewire: 0.038 in Soft atraumatic tip to minimize vessel trauma Packaging available in: SINGLE CATHETER OPTIONS: • 100 Series­- 100 single catheter pouches per box Hydrophobic coated shaft • 500 Series­- 5 single catheter pouches per box CATHETER KIT OPTIONS (3 single catheters per tray): • 300 Series - 50 or 5 kits per box • 400 Series - 1 kit, guidewire, and Adelante® Sigma Curve retention for accurate catheter placement Introducer Kit per box Judkins Right Straight Pigtail or Pigtail 145° Judkins Left 30 | www.oscor.com Product Portfolio | 31 VENOGRAPHY CATHETERS Venos® Occlusion Balloon Catheter One way stopcock The Venos® Occlusion Balloon Catheter is a latex-free double lumen occlusion balloon catheter. It is intended for temporary occlusion of the coronary sinus during a venogram or infusion of contrast media or drug. ID Sizes: 5 F and 6 F Lengths: 80 or 100 cm Balloon Diameters: 10 or 15 mm Accepts Maximum Guidewire: 0.025 or 0.035 in Guidewire and infusion lumen Inflation volume indicator Packaging available in: • 1 Venos® occlusion balloon catheter and 1 volume limited syringe French size color coded hub 10 mm 15 mm Depth markings Latex-free compliant balloon 32 | www.oscor.com Product Portfolio | 33 EXTERNAL PACEMAKERS Incorporating over 30 years experience in external pulse generator design, state of the art pacing technology, and attention to ergonomic design features. Oscor’s line of external pacemakers include single chamber, dual chamber, and the world’s first and only triple chamber devices. All Oscor external pulse generators are compatible with Oscor’s line of temporary pacing leads and connection cables. Pace 101H Single Chamber Temporary Cardiac Pacemaker (SSI) Pace 203H Dual Chamber Temporary Cardiac Pacemaker (DDD) Pace 300 Triple Chamber Temporary Cardiac Pacemaker (CRT) *Not available for US market 34 | www.oscor.com Product Portfolio | 35 TEMPORARY PACING LEADS TB™ Bipolar Temporary Pacing Lead TB is a bipolar temporary pacing lead used for temporary ventricular or atrial pacing in connection with a temporary pacemaker. Lead Body Diameter: Length: 110 cm 4 F, 5 F, and Depth Markings at every 10 cm 6F Packaging available in: • 1 TB temporary pacing lead French size and color coded hub • TB Convenience Kit Shrouded Unshrouded Straight 60˚ Curve Atrial-J Curve Right Heart Curve Available in different curves (Custom curve configurations available upon request) 36 | www.oscor.com Product Portfolio | 37 TEMPORARY PACING LEADS Helios™ Flow Directed Temporary Pacing Lead with Balloon Atraumatic tip The Helios temporary pacing lead with 8 mm balloon is a latex-free radiopaque flow directed bipolar temporary pacing lead with balloon. It is suitable for both recording intracardiac signals and temporary pacing. Latex-free compliant balloon Lead Body Diameter: 5 F Length: 110 cm Balloon Diameter: 8 mm Curves: Straight or Right Heart Depth markings ™ Packaging available in: • 1 Helios™ temporary pacing lead with balloon and 1 volume limited syringe One way stopcock • Helios™ Convenience kit Shrouded Unshrouded Right Heart Curve 38 | www.oscor.com Straight Available in different curves (Custom curve configurations available upon request) Product Portfolio | 39 MYOCARDIAL HEART WIRES TME™ UNIPOLAR SERIES Temporary Myocardial Heartwire The Oscor TME™ line of temporary myocardial pacing wires (heartwires) are designed to provide consistent temporary sensing and pacing during and after cardiac surgery while providing minimal trauma to the myocardium. Features: • Zig-zag, tines, or v-hook fixation mechanism • Unipolar, bipolar, bipolar pediatric, quadripolar, or quadripolar pediatric series • Curved or straight thoracic needle • Single wire or bifurcated wire design • Supplied with 2 mm pin adaptors BIPOLAR SERIES BIPOLAR PEDIATRIC SERIES QUADRIPOLAR SERIES QUADRIPOLAR PEDIATRIC SERIES 40 | www.oscor.com Product Portfolio | 41 CONNECTION CABLES ATAR-T SERIES ATAR™ Temporary Extension Cables Oscor also offers temporary extension cables to connect temporary pacing leads (like Oscor TB Series) and pacing wires (like Oscor TME™ Series) to external pacemakers (like Oscor PACE 101H, 203H, or 300). The extension cable features the patented 2 mm protected quick connection allowing safe and fast connection to pacemaker and temporary pacing lead or wire. The receptacle portion of the cables accepts pacing lead/wire connectors ranging from 2 mm down to 0.9 mm connectors or needles. 2 mm Male Shrouded Pin ATAR-R SERIES Covered Alligator Clip 2 mm Male Shrouded Pin ATAR-MDT 2 SERIES ATAR-A SERIES (Color coded for Atrium) 2 mm Male Shrouded Pin 2 x 0.5 mm Male Pin Receptacle 0.9 - 2 mm Female Pin Receptacle *ATAR D-IS1 R SERIES ATAR-V SERIES (Color coded for Ventricle) 0.9 - 2 mm Female Pin Receptacle 2 mm Male Shrouded Pin ATAR-MDT SERIES 2 x 0.5 mm Female Pin Receptacle 0.9 - 2 mm Female Pin Receptacle 2 mm Female Shrouded Pin Receptacle 2 mm Male Shrouded Pin IS-1 (3.2 mm) Connector Pin Covered Alligator Clip * Available for special order only. 42 | www.oscor.com Product Portfolio | 43 IMPLANTABLE LEAD ADAPTORS Adaptors Implantable Lead Adaptors and Extensions To fulfill every possible need between all lead connectors to pulse generator header, Oscor offers the industry’s broadest line of implantable lead adaptors and lead extensions. Oscor lead adaptors carry FDA and CE approval. Oscor also offers custom adaptor and connector configurations. Features: • Unipolar and Bipolar Adaptors • Lead Extensions • Bifurcated Adaptor Configurations featuring connections: ·· IS-1 (3.2 mm) Unipolar/Bipolar ·· 5 mm Unipolar ·· 6 mm Unipolar/Bipolar ·· LV-1 Unipolar/Bipolar ·· IS4 / DF4 (Pending FDA & CE approval) ·· Custom connections 44 | www.oscor.com Product Portfolio | 45 ACCESSORIES General Pacing Accessories LIGATURE SLEEVE From cardiovascular pacing cables and adaptors, suture sleeves, lead stylets, introducer and surgical convenience kits to custom medical components, Oscor offers complete solutions for all your pacing, cardiac surgery and interventional accessory needs. VV-PLUG (3.2 mm) PY FIXATION TOOL LV-1 PLUG PIN ADAPTOR SET IS4/ DS4 PLUG GUIDEWIRE END CAP UNIVERSAL ADAPTER SLEEVE 46 | www.oscor.com STYLETS Product Portfolio | 47 ACCESSORIES IS4/DF4 Plug D The IS4/DF4 plug fulfills the need to block the unused receptacle in a pacemaker/defibrillator header. The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle. B A C 48 | www.oscor.com Model # IS4/DF4 Plug A — Overall Length 40 mm B — Connector Length 22 mm C — Silicone Extension Diameter 4 mm D — Connector Diameter 3.20 mm Product Portfolio | 49 ACCESSORIES VEIN PICKS The Vein Pick is a disposable plastic accessory designed to facilitate introduction of lead, catheter or devices alike; in the event of cut-down procedure. VEIN PICK - SHORT 9 mm 45 mm VEIN PICK - LONG 10 mm 110 mm 50 | www.oscor.com Product Portfolio | 51 HOSPITAL EQUIPMENT Acero™ Stainless Steel Cath Lab Tables Oscor’s new line of stainless steel tables addresses a wide range of laboratory and cleanroom requirements, while providing corrosion proof performance, ensuring long life and maximum value for your investment. Features: • Fixed or adjustable table height-from 34.5˝ to 43.5˝ • Built from medical grade 304 L stainless steel • Optimum load bearing performance up to 400 pounds • Heavy duty casters with 4 position swivel lock and side foot brake • Ergonomic rounded 180˚ rolled edges throughout • Easy to assemble in minutes • Custom design available upon request • Made in the USA 52 | www.oscor.com Product Portfolio | 53 MEDICAL OEM SOLUTIONS Oscor is offering its medical device experience and its engineering and manufacturing capabilities on an OEM basis to solve your medical device requirements and needs. Our product development team provides project management, engineering services, rapid prototyping, product testing, process validation, volume production setup, and all the way to cost reduction management. PRODUCT DEVELOPMENT Stock Components Prototyping Customization Process Development VERIFICATION + VALIDATION We offer: • Product development • Rapid prototyping • Product testing • Global regulatory services • High volume cleanroom manufacturing • Turnkey packaging • Sterilization - Validation and Services • Low cost offshore manufacturing • Worldwide distribution and inventory management Our in-house vertical capabilities: • Product engineering and project management • Mold and tooling, design, and manufacturing • Injection molding (Insert, overmolding, LIM, micromolding) • Tubing extrusion (profile, multilumen, coextrusion) • Braiding and coiling • Tipping, pad printing, coating • Laser welding, marking, cutting • CNC machining • Cleanroom manufacturing • Turnkey packaging • Sterilization • Global Regulatory • Global Distribution 54 | www.oscor.com Process Validation Design Verification Testing TRANSFER TO PRODUCTION Production Setup Turnkey Packaging Sterilization Regulatory Submission/ Approvals COMMERCIALIZATION Global Product Launch and Distribution PRODUCTION Volume Production Inventory Management Global Supply Chain Management Continuous Cost Reduction Management TRUE OUTSOURCING PARTNERSHIP Product Portfolio | 55 PP100-031816-00 OSCOR INC. | WORLD HEADQUARTERS Toll Free: 1-800-726-7267 P: +1 727-937-2511 OSCOR EUROPE GMBH | GERMANY DIRECT SALES Telefon kostenlos: 0800 00-67267 P: +49 (0) 211 586 786-00 CONTACT US www.oscor.com sales@oscor.com