ACCESS. GUIDING. DIAGNOSTIC. PRODUCT PORTFOLIO

Transcription

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
®
®
The Adelante SafeSheath Ultra Lite Peel Away
Introducer System, features a speciallly engineered
valve membrane that allows for reduced forces
during insertion.
Sheath Lengths: 13 cm
Dilator Lengths: 18 cm
Screw-locking
dilator connector
Color coded
introducer cap /
hemostatic valve
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 | www.oscor.com
INTRODUCERS
Adelante® SafeSheath II
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 Lengths: 13 or 23 cm
Dilator Lengths: 19.5 or 29.5 cm
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
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
Dilator Lengths: 15 or 28 cm
Reliable
hemostatic seal
• Sheath, dilator and guidewire only
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
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
Dilator and sheath
in locked position
Reliable
hemostatic seal
Luer connect
mechanism
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
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
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 | www.oscor.com
Elongated dilator to sheath
transition for easy access
Smooth guidewire/
dilator transition
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
Dilator Lenghts: 25, 35 or 40 cm
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
Reinforced
atraumatic distal
tip with marker
band
Smooth sheath to
dilator transition
Smooth dilator to
guidewire
transition
18 | www.oscor.com
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
hemostatic valve
Snap-locking
dilator connector
Advanced
Flexsteer™ braided
shaft technology
Hydrophobic coated
sheath
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
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.
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
Braided Flexsteer™
shaft technology
EnSilk™ hydrophilic
coating technology
MP Curve
RDC Curve
TD Curve
Soft atraumatic
radiopaque tip
LIMA Curve
Smooth sheath to
dilator transition
22 | www.oscor.com
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
Clear view of the
distal marker band
under fluoroscopy
Smooth tip to
dilator transition
Advanced
Flexsteer™ braided
shaft technology
Hydrophobic coated
sheath
Rotating collar
Tip position indicator
Ticha Damascelli (TD) Curve
hemostatic valve
Straight
French size and
guidewire indicator
24 | www.oscor.com
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
Dilator Lengths: 85, 90 or 94 cm
Curve Sizes: 17, 22, or 50 mm
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
• Kit with accessories
hemostatic valve
• Sheath, dilator, and guidewire set
Depth markings
50 mm
22 mm
17 mm
French size and
guidewire indicator
Bi-directional curve sizes
26 | www.oscor.com
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
Smooth tip to dilator
transition. Sheath tip
with two side holes
Hydrophobic
coated sheath
Braided Flexsteer™
shaft technology
Rotating collar
Tip position indicator
hemostatic valve
50 mm
22 mm
17 mm
Depth markings
for easy
identification and
placement
Bi-directional curve sizes
28 | www.oscor.com
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
Soft atraumatic tip
to minimize vessel
trauma
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
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
• 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
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
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
• 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
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
™
• 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
(Custom curve configurations
available upon request)
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
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
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
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
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
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
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
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
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
[email protected]

ACCESS. GUIDING. DIAGNOSTIC. PRODUCT PORTFOLIO

Transcription

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