PRODUCT PORTFOLIO ACCESS GUIDING DIAGNOSTIC

Transcription

1 PRODUCT PORTFOLIO ACCESS GUIDING DIAGNOSTIC

2 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.

3 SOLUTIONS PRODUCTS Cardiac Rhythm Interventional Cardiology Interventional Radiology Cardiac Surgery Introducers Peel Away Sheath Peel Away Sheath with Valve Valved Access Sheath Radial Access Sheath Large Access Sheath Guiding Sheaths Fixed Sheath Deflectable Sheaths Angiography Catheters Venography Catheters External Pacemakers Temporary Pacing Leads Transvenous Pacing Balloon Flow Directed Myocardial Heart Wires Connection Cables Implantable Lead Adaptors Accessories Medical OEM Solutions

4 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. Dilator tip indicator French size color coding 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: in Ergonomic handles Sheath, dilator and accessories Sheath and dilator only Bulk non-sterile Consistent peel Hydrophobic coated sheath Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 6 Product Portfolio 7

5 INTRODUCERS Adelante SafeSheath Ultra Lite Peel Away Sheath with Valve The Adelante SafeSheath Ultra Lite Peel Away Introducer System, features a specially 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: in Screw-locking dilator connector Color coded introducer cap / hemostatic valve Sheath, dilator and accessories Sheath and dilator only Bulk non-sterile Consistently clean and smooth peel * 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 Product Portfolio 9

6 INTRODUCERS Adelante SafeSheath II Peel Away Sheath with 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. Lubricated hemostatic valve Snap-locking dilator cap with French size indicator Sheath ID Sizes: 6 F to 12.5 F Sheath Lengths: 13 or 23 cm Dilator Lengths: 19.5 or 28.5 cm Accepts Maximum Guidewire: in Ergonomic, easy splitting hub with color-coded cap Sheath, dilator and accessories Hydrophobic coated sheath * SafeSheath is a registered trademark of Pressure Products, Inc. 3-way stopcock Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 10 Product Portfolio 11

7 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. Sheath ID Sizes: 4 F to 12 F Sheath Lengths: 10 or 23 cm Dilator Lengths: 15 or 28 cm Accepts Maximum Guidewire: in Sheath, dilator and accessories Sheath, dilator and guidewire only Sheath and dilator only Bulk non-sterile Snap-locking dilator connector French size and guidewire indicator Reliable hemostatic seal Kink resistant, flexible, and hydrophobic coated sheath Color coded side port and 3-way stopcock Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 12 Product Portfolio 13

8 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) Dilator and sheath in locked position Sheath ID Sizes: 4 F to 8 F Sheath Lengths: 10 or 23 cm Dilator Lengths: 15 or 28 cm Accepts Maximum Guidewire: in Reliable hemostatic seal Sheath, dilator and accessories Sheath and dilator only Bulk non-sterile Luer connect mechanism Kink resistant, flexible, and hydrophobic coated sheath Smooth dilator/ sheath transition Smooth guidewire/ dilator transition 14 Product Portfolio 15

9 INTRODUCERS Adelante Radial Radial Access Sheath 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. Snap-locking dilator connector 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: in EnSilk hydrophilic coating technology 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 Elongated dilator to sheath transition for easy access Smooth guidewire/ dilator transition Product Portfolio 17

10 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. Dilator with French size and guidewire indicator Color coded hub with SureSeal hemostatic valve Multi-layer sheath with EnSilk hydrophilic coating technology Sheath ID Sizes: 16 F, 18 F, 19 F and 21 F Sheath Lengths: 20, 30 or 35 cm Dilator Lengths: 25, 35 or 40 cm Accepts Maximum Guidewire: in Depth markings for easy identification and placement 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 Product Portfolio 19

11 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. Reliable SureSeal hemostatic valve Snap-locking dilator connector Sheath ID Sizes: 8 F and 10 F Sheath Lengths: 61 or 79 cm Dilator Lengths: 66 or 84 cm Accepts Maximum Guidewire: in Advanced Flexsteer braided shaft technology Sheath and dilator only Bulk non-sterile Hydrophobic coated sheath Straight 55 Soft atraumatic radiopaque tip Two side holes 120 Available in different curves (Custom curve configurations available upon request) Smooth sheath / dilator transition 20 Product Portfolio 21

12 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, 35, 39, or 50 mm Accepts Maximum Guidewire: in Clear view of the distal marker band under fluoroscopy Smooth tip to dilator transition Advanced Flexsteer braided shaft technology Hydrophobic coated sheath Sheath and dilator only Tip position indicator Reliable SureSeal hemostatic valve Ticha Damascelli (TD) Curve Straight Available in different curves (Custom curve configurations available upon request) French size and guidewire indicator 22 Product Portfolio 23

13 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. 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 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. Hydrophobic coated sheath Sheath ID Sizes: 8.5 F, 10 F, and 12 F Sheath Lengths: 61, 67 or 71 cm Dilator Lengths: 85, 90 or 94 cm Curve Sizes: 17, 22, or 50 mm Accepts Maximum Guidewire: in Kit with accessories Sheath, dilator, and guidewire set Sheath and dilator only Easy locking ergonomic steering handle with curve, length & french size indicator Reliable SureSeal hemostatic valve Depth markings 50 mm 22 mm 17 mm French size and guidewire indicator Bi-directional curve sizes 24 Product Portfolio 25

14 GUIDING SHEATHS Destino Reach Bi-Directional Deflectable Guiding Sheath The Destino Reach is the next generation bidirectional steerable guiding sheath, featuring improved deflection, greater 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. 50 curve dilator Bi-directional deflection 180 / 180 Clear view of the distal marker band under fluoroscopy Smooth tip to dilator transition. Sheath tip with two side holes Hydrophobic coated sheath 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: in Rotating collar Braided Flexsteer shaft technology Sheath and dilator only Tip position indicator Reliable SureSeal hemostatic valve 50 mm 22 mm 17 mm Bi-directional curve sizes Depth markings for easy identification and placement 26 Product Portfolio 27

15 ANGIOGRAPHY CATHETERS Angios Classic Diagnostic Angiographic Catheter 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. ID Sizes: 5 F and 6 F Lengths: 65, 80, 90, 100, 110, or 120 cm Accepts Maximum Guidewire: in SINGLE CATHETER OPTIONS: 100 Series single catheter pouches per box 500 Series - 5 single catheter pouches per box Pigtail tip straightener Color coded Soft atraumatic tip to minimize vessel trauma Hydrophobic coated shaft KIT OPTIONS (3 single catheters per tray): 300 Series - 50 kits per box 400 Series - 1 kit, guidewire, and Adelante Sigma Introducer Kit per box Curve retention for accurate catheter placement Judkins Right Straight Pigtail or Pigtail 145 Judkins Left 28 Product Portfolio 29

16 ANGIOGRAPHY CATHETERS Angios Specialty Diagnostic Angiographic Catheter 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. Color coded ID Sizes: 5 F and 6 F Lengths: 100, 110, or 120 cm Accepts Maximum Guidewire: in SINGLE CATHETER OPTIONS: 100 Series single catheter pouches per box 500 Series - 5 single catheter pouches per box Soft atraumatic tip to minimize vessel trauma AR I MOD IM AR II MOD MPA I Hydrophobic coated shaft AL I NIH Curve retention for accurate catheter placement AL II TALON Product Portfolio 31

17 VENOGRAPHY CATHETERS Venos Occlusion Balloon Catheter 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: or in 1 Venos occlusion balloon catheter and 1 volume limited syringe One way stopcock Inflation volume indicator Guidewire and infusion lumen French size color coded hub 10 mm 15 mm Depth markings Latex-free compliant balloon 32 Product Portfolio 33

18 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 Product Portfolio 35

19 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: 4 F, 5 F, and 6 F Length: 110 cm Depth Markings at every 10 cm 1 TB temporary pacing lead TB Convenience Kit French size and color coded hub Shrouded Unshrouded Straight 60 Curve Atrial-J Curve Right Heart Curve Available in different curves (Custom curve configurations available upon request) 36 Product Portfolio 37

20 TEMPORARY PACING LEADS Helios Flow Directed Temporary Pacing Lead with Balloon 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. Atraumatic tip Latex-free compliant balloon Lead Body Diameter: 5 F Length: 110 cm Balloon Diameter: 8 mm Curves: Straight or Right Heart Depth markings 1 Helios temporary pacing lead with balloon and 1 volume limited syringe Helios Convenience kit One way stopcock Shrouded Unshrouded Right Heart Curve Straight Available in different curves (Custom curve configurations available upon request) 38 Product Portfolio 39

21 MYOCARDIAL HEART WIRES TME Temporary Myocardial Heartwire UNIPOLAR SERIES 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. BIPOLAR SERIES 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 PEDIATRIC SERIES QUADRIPOLAR SERIES QUADRIPOLAR PEDIATRIC SERIES 40 Product Portfolio 41

22 CONNECTION CABLES ATAR Temporary Extension Cables The ATAR Temporary Extension Cables connect temporary pacing leads (such as Oscor TB and Helios Series) and pacing wires (such as Oscor TME Series) to external pacemakers (such as Oscor PACE 101H, 203H, or 300). The extension cable features the patented 2 mm protected quick connection pin 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. ATAR D-T ATAR D-R 2 mm Male Shrouded Pin 2 mm Female Shrouded Pin Receptacle Covered Alligator Clip 2 mm Male Shrouded Pin ATAR D-A (Color coded for Atrium) ATAR D-MDT mm Female Pin Receptacle 2 mm Male Shrouded Pin 2 x 0.5 mm Female Pin Receptacle 2 mm Male Shrouded Pin ATAR D-V (Color coded for Ventricle) ATAR D-MDT mm Female Pin Receptacle 2 mm Male Shrouded Pin 2 x 0.5 mm Male Pin Receptacle mm Female Pin Receptacle 42 Product Portfolio 43

23 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 CE approval) Custom connections 44 Product Portfolio 45

24 ACCESSORIES General Pacing Accessories 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) LIGATURE SLEEVE LV-1 PLUG PY FIXATION TOOL IS4 / DS4 PLUG GUIDEWIRE 46 Product Portfolio 47

25 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 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 48 Product Portfolio 49

26 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 Product Portfolio 51

27 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. 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 PRODUCT DEVELOPMENT Stock Components Prototyping Customization Process Development VERIFICATION + VALIDATION Process Validation Design Verification Testing TRANSFER TO PRODUCTION Production Setup Turnkey Packaging Sterilization Regulatory Submission/ Approvals 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 COMMERCIALIZATION Global Product Launch and Distribution PRODUCTION Volume Production Inventory Management Global Supply Chain Management Continuous Cost Reduction Management TRUE OUTSOURCING PARTNERSHIP 52 Product Portfolio 53

28 MEDICAL OEM SOLUTIONS PRODUCT CATEGORIES Being a finished device manufacturer for over 35 Years, Oscor is the industry-leading outsourcing partner for turnkey design and manufacture of minimal invasive and long term implantable devices. We offer innovative solutions in the development of newest product platforms for: Cardiac Pacing Electrophysiology Neuro Stimulation Cardiovascular Peripheral Structural Heart Specialty Devices 54 Product Portfolio 55

29 OSCOR INC. WORLD HEADQUARTERS Toll Free: P: PP OSCOR EUROPE GMBH GERMANY DIRECT SALES Telefon kostenlos: P: +49 (0) CONTACT US