Publication - Vascular Solutions

Transcription

2016
I N T E R N AT I O N A L
P R O D U C T C ATA L O G
Disclaimer: This International Product Catalog is intended for healthcare professionals in certain markets outside of the United States where the featured Vascular Solutions’ products are approved for use as indicated by the respective
Instructions for Use (IFUs). This catalog is not intended for users in the United States as they may contain products and indications that are not authorized for use in the United States.
Driven by clinical needs and supported by
innovative thinking, Vascular Solutions offers
a rapidly growing product line that spans both
coronary and peripheral vascular treatments.
Cardiologists, radiologists, electrophysiologists
and vein specialists worldwide rely on the quality
and proven clinical effectiveness of our products.
Contents
ACCESS
SmartNeedle Vascular Access System.................................................. 5
SPECIALTY CATHETERS
GuideLiner Catheters............................................................................... 7
GuideLiner XL Catheter............................................................................ 8
Navigation Catheters............................................................................... 9
Venture Catheters.................................................................................. 10
Turnpike Catheters................................................................................. 11
SuperCross 0.014" Microcatheters...................................................... 12
Minnie Support Catheters..................................................................... 13
Twin-Pass Dual Access Catheters......................................................... 14
Langston Dual Lumen Catheters.......................................................... 15
ASPIRATION CATHETERS
Pronto V4 Extraction Catheters............................................................. 17
Pronto V3 Extraction Catheter............................................................... 18
Pronto LP Extraction Catheters............................................................. 19
Pronto .035" Extraction Catheter.......................................................... 20
Pronto XL 8F and 14F Extraction Catheters......................................... 21
Pronto-Short Extraction Catheter......................................................... 22
ELECTROPHYSIOLOGY
Venture CS Catheter............................................................................... 24
EMBOLIZATION
Gel-Bead Embolization Spheres........................................................... 26
GUIDEWIRES
R350 Guidewire...................................................................................... 28
HEMOSTASIS
D-Stat Dry Topical Hemostat................................................................. 30
Hunter Biopsy Sealing Device................................................................ 31
Hep-Plug Sealing Device........................................................................ 32
INTERVENTIONAL ACCESSORIES
Guardian II Hemostasis Valve................................................................ 34
RADIAL ACCESS
D-Stat Radial Topical Hemostat............................................................ 36
SNARES
Micro Elite Snare.................................................................................... 38
Expro Elite Snare.................................................................................... 39
VEIN TREATMENT
Vari-Lase 810nm Endovenous Laser Console..................................... 41
Vari-Lase 1470nm Endovenous Laser Console................................... 42
Vari-Lase Platinum Bright Tip Laser Fiber & Procedure Kits.............. 43
Veinsite Vein Viewing Headset............................................................... 44
Auto-Fill Syringe Kit............................................................................... 45
ORDERING INFORMATION..................................................................... 46
ACCESS
AC C E S S
Auditory Feedback for Complete
Clinical Confidence
Simplifies vascular access
From challenging anatomies to everyday use
ORDERING INFORMATION
Monitor
Model
Description
72000
SmartNeedle Percutaneous Doppler Monitor
Box Quantity
1
Bare Tip Needles
Model
Description
Needle Usable Length
Needle O.D.
Max Needle Guidewire
Box Quantity
78030
78040
22G Bare Tip Needle
1.875"/48mm
22G
0.021"/0.53mm
10
20G Bare Tip Needle
1.50"/38mm
20G
0.025"/0.64mm
10
78050
18G Bare Tip Needle
2.75"/70mm
18G
0.038"/0.97mm
10
78060
18G Extended Bare Tip Needle
3.50"/89mm
18G
0.038"/0.97mm
5
Devices packaged in the quantities listed above.
Please see the Instructions for Use for a complete listing of the indications, contraindications,
warnings and precautions.
5 | AC C E S S
SmartNeedle devices are indicated when blood flow must be detected for percutaneous vessel cannulation.
The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or
larger. The SmartNeedle Monitor audibly indicates the Doppler response of blood flow within an artery or vein. It
is intended for use only in conjunction with the Vascular Solutions’ SmartNeedle Percutaneous Doppler Vascular
Access Device.
SPECIALTY
CATHETERS
S P E C I A LT Y CAT H E T E R S
A Fast and Smooth Run
Rapid exchange guide extension
Half-pipe collar for smooth device entry
Multiple size options
Model
Size
Required Guide
Catheter I.D.
GuideLiner I.D.
Rapid Exchange Length
Working Length
Box Quantity
5569
5F
5F I.D. ≥0.056"
(1.42mm)
0.046"
(1.17mm)
25cm
150cm
1
5570
5.5F
6F I.D. ≥0.066"
(1.68mm)
0.051"
(1.30mm)
25cm
150cm
1
5571
6F
6F I.D. ≥0.070"
(1.78mm)
0.056"
(1.42mm)
25cm
150cm
1
5572
7F
7F I.D. ≥0.078"
(1.98mm)
0.062"
(1.57mm)
25cm
150cm
1
5573
8F
8F I.D. ≥0.088"
(2.24mm)
0.071"
(1.80mm)
25cm
150cm
1
Packaged in quantities of 1 unit per box.
7 | S P E C I A LT Y CAT H E T E R S
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the
coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Extra Long 40cm Guide Extension
Maintains collar transition in less tortuous anatomy
Allows up to 15cm extension out of guide
Model
Size
Required Guide Catheter I.D.
GuideLiner I.D.
Working Length
Box Quantity
5576
6F
6F I.D. ≥0.070"
(1.78mm)
0.056"
(1.42mm)
40cm
150cm
1
GuideLiner XL catheter is intended to be used in conjunction with a guide catheter to access discrete regions of
the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Arterial Wall Protection during
GuideLiner Deep-Seating
Dilator-like design
Support for GuideLiner advancement
through tortuous anatomy
Guidewire
GuideLiner
Navigation Catheter
GuideLiner
Model
Compatible GuideLiner Catheter
(French size/model)
5470
5.5F (5570)
25cm
0.014"/0.36mm
5471
6F (5571)
25cm
0.014"/0.36mm
5472
7F (5572)
25cm
0.014"/0.36mm
5473
8F (5573)
25cm
0.014"/0.36mm
9 | AC
SPC
EE
CS
I ASLT Y CAT H E T E R S
Maximum Guidewire
Diameter
Maximum Distal Shaft O.D.
Working Length
Box Quantity
0.050"/1.27mm
163cm
1
0.055"/1.40mm
163cm
1
0.061"/1.55mm
163cm
1
0.070"/1.78mm
163cm
1
The Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions
of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional
devices.
True Control in a Deflectable Tip
Precise guidewire placement
Handle-to-tip torque transmission
8mm platinum tip
Model
Guidewire
Compatibility
Guide
Catheter
Compatibility
Working
Length
Rapid
Exchange
Segment
Radiopaque
Tip
Hydrophilic
Coating
Distal Tip Entry
Profile
Deflectable Tip O.D.
Proximal O.D. /
Transition Collar O.D. (RX)
I.D.
Box
Quantity
5820 - Rapid
Exchange (RX)
0.014"
6F (1.7mm)
145cm
30cm
8mm
Distal
24cm
1.8F
(0.61mm / 0.024")
2.2F
(0.74mm / 0.029")
4.1F
(1.37mm / 0.054")
0.018"
(0.46mm)
1
5821 Over-the-Wire
(OTW)
0.014"
6F (1.7mm)
140cm
N/A
8mm
Distal
45cm
1.8F
(0.61mm / 0.024")
2.2F
(0.74mm / 0.029")
4F
(1.32mm / 0.052")
0.018"
(0.46mm)
1
5822 - Coronary
Sinus (CS)
0.014"
6F (1.7mm)
70cm
N/A
8mm
N/A
1.8F
(0.61mm / 0.024")
2.2F
(0.74mm / 0.029")
4F
(1.32mm / 0.052")
0.018"
(0.46mm)
1
The Venture catheters are indicated for directing, steering, controlling, and supporting a guidewire to access
discrete regions of the coronary and peripheral vasculature. The Venture OTW and Venture CS catheters may also
be used for manual delivery of saline solution or diagnostic contrast agents.
Turning through
Complex Interventions
Turnpike
Multi-layer shaft provides flexibility and torque response
Flexible, tapered tip for superior tracking
Turnpike Gold
Gold-plated, threaded metallic tip
for enhanced advancement
Turnpike Spiral
Distal nylon coil provides rotational
assistance for enhanced trackability
Turnpike LP
Low-profile version with greater tip and distal shaft
flexibility for advancement through extreme tortuosity
Model
Description
Working Length
Proximal Shaft O.D.
(max.)
Distal Shaft O.D.
Distal Tip O.D.
Compatible Guidewire
Diameter
Compatible Guide Catheter Size
Box Quantity
5642
Turnpike
135cm
3.1F
(1.02mm / 0.040")
2.6F
(0.86mm / 0.034")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5643
Turnpike
150cm
3.1F
(1.02mm / 0.040")
2.6F
(0.86mm / 0.034")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5638
Turnpike LP
135cm
3.1F
(1.02mm / 0.040")
2.2F
(0.74mm / 0.029")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5639
Turnpike LP
150cm
3.1F
(1.02mm / 0.040")
2.2F
(0.74mm / 0.029")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5640
Turnpike Spiral
135cm
3.1F
(1.02mm / 0.040")
3.1F
(1.02mm / 0.040")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5641
Turnpike Spiral
150cm
3.1F
(1.02mm / 0.040")
3.1F
(1.02mm / 0.040")
1.6F
(0.53mm / 0.021")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
5621
Turnpike Gold
135cm
3.1F
(1.02mm / 0.040")
3.2F
(1.07mm / 0.042")
2.1F
(0.71mm / 0.028")
≤0.014" (0.36mm)
≥5F
(≥1.42mm / 0.056" ID)
1
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral
vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/
deliver diagnostic and therapeutic agents.The Turnpike Spiral and Turnpike Gold catheters are contraindicated for
use in vessels with an effective diameter smaller than 1mm.
STRAIGHT - FT
ANGL
45°
0.014" Superior Crossability
in Tortuous Anatomy
Straight for guidewire tracking
Angled for navigating bifurcated vessels
Torque response through tortuosity
ED TI
PS
90°
120°
XT
Model
Type
Guidewire
Compatibility
Distal Tip
Working
Length
Shaft
Construction
Distal O.D.
Proximal O.D.
Distal I.D.
Proximal I.D.
Hydrophilic
Coating
Box
Quantity
5302
OTW
0.014"
45°
130cm
Coiled
1
5303
OTW
0.014"
45°
150cm
Coiled
1
5304
OTW
0.014"
90°
130cm
Coiled
1
5305
OTW
0.014"
90°
150cm
Coiled
1
5306
OTW
0.014"
120°
130cm
Coiled
5307
OTW
0.014"
120°
150cm
Coiled
1
5308
OTW
0.014"
90° XT
130cm
Coiled
1
5309
OTW
0.014"
90° XT
150cm
Coiled
1
5350
OTW
0.014"
90°
80cm
Coiled
5351
OTW
0.014"
120°
80cm
Coiled
5300
OTW
0.014"
Straight
130cm
Braided
5301
OTW
0.014"
Straight
150cm
Braided
5340
OTW
0.014"
FT
130cm
Braided
5341
OTW
0.014"
FT
150cm
Braided
FT = Flexible Tip | XT = Extended Tip
2.4F
(0.79mm / 0.031")
3.2F
(1.07mm / 0.042")
0.017"
(0.43mm)
0.018"
(0.46mm)
Distal 80cm
2.4F
(0.79mm / 0.031")
3.2F
(1.07mm / 0.042")
0.017"
(0.43mm)
0.018"
(0.46mm)
Distal 40cm
1.8F
(0.61mm / 0.024")
2.5F
(0.84mm / 0.033")
0.017"
(0.43mm)
0.021"
(0.53mm)
Distal 40cm
1.8F
(0.61mm / 0.024")
2.5F
(0.84mm / 0.033")
0.017"
(0.43mm)
0.021"
(0.53mm)
Distal 40cm
1
1
1
1
1
1
1
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access
discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement
and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic
and therapeutic agents.
Essential Guidewire Support
and Exchange
Enhanced deliverability
Smooth guidewire movement
Maximum
Guidewire
Diameter
Working
Length
Minimum
Guide
Catheter
5700
0.014"
135cm
5701
0.014"
5702
Model
Proximal Shaft
Distal Shaft
Distal Tip
Radiopaque
Marker
Spacing-A
Radiopaque
Marker
Spacing-B
Saline Flow
Rate at 300
psi2
Contrast
Flow Rate1 at
300 psi2
Box
Quantity
I.D.
O.D.
I.D.
O.D.
I.D.
O.D.
5F
0.019"
0.48mm
0.039"
0.99mm
0.0165"
0.42mm
0.026"
0.66mm
0.0155"
0.39mm
0.0205"
0.52mm
15mm
-
1.1
0.4
1
150cm
5F
0.019"
0.48mm
0.039"
0.99mm
0.0165"
0.42mm
0.026"
0.66mm
0.0155"
0.39mm
0.0205"
0.52mm
15mm
-
1.0
0.4
1
0.018"
90cm
6F
0.024"
0.61mm
0.044"
1.12mm
0.0205"
0.52mm
0.030"
0.76mm
0.0195"
0.50mm
0.0235"
0.60mm
15mm
-
2.4
1.4
1
5703
0.018"
135cm
6F
0.024"
0.61mm
0.044"
1.12mm
0.0205"
0.52mm
0.030"
0.76mm
0.0195"
0.50mm
0.0235"
0.60mm
15mm
-
2.0
1.1
1
5704
0.018"
150cm
6F
0.024"
0.61mm
0.044"
1.12mm
0.0205"
0.52mm
0.030"
0.76mm
0.0195"
0.50mm
0.0235"
0.60mm
15mm
-
1.8
0.9
1
5705
0.035"
65cm
6F
0.041"
1.04mm
0.063"
1.60mm
0.0385"
0.98mm
0.050"
1.27mm
0.0365"
0.93mm
0.0415"
1.05mm
25mm
50mm
10.8
9.0
1
5706
0.035"
90cm
6F
0.041"
1.04mm
0.063"
1.60mm
0.0385"
0.98mm
0.050"
1.27mm
0.0365"
0.93mm
0.0415"
1.05mm
25mm
50mm
9.3
8.1
1
5707
0.035"
135cm
6F
0.041"
1.04mm
0.063"
1.60mm
0.0385"
0.98mm
0.050"
1.27mm
0.0365"
0.93mm
0.0415"
1.05mm
25mm
50mm
7.6
6.6
1
5708
0.035"
150cm
6F
0.041"
1.04mm
0.063"
1.60mm
0.0385"
0.98mm
0.050"
1.27mm
0.0365"
0.93mm
0.0415"
1.05mm
25mm
50mm
7.2
5.8
1
0.014"
0.018"
0.035"
1
Flow rates achieved at 4.3cP. Actual results may vary. 2 Maximum pressure rating.
Devices packaged in the quantities listed above.
The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to
access discrete regions of the arterial and/or coronary vasculature. They may be used to facilitate placement
and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to
subselectively infuse/deliver therapeutic agents.
A Second Lumen,
When and Where it’s Needed
In-place guidewire can remain while the second lumen is used for:
Targeted delivery of medications or contrast
Supportive access to side branches
Specifications:
Twin-Pass Model 5200
Guide catheter compatibility
≥6F (0.066" min. I.D.)
Guidewire compatibility – RX lumen
≤0.014" (0.36mm)
Guidewire compatibility – OTW lumen
≤0.014" (0.36mm)
RX lumen I.D.
0.017" (0.43mm)
OTW lumen I.D.
0.018" (0.46mm)
O.D. – across both lumens
3.5F
Distal tip profile
2F x 12mm
Working length
135cm
RX lumen length
21cm
Proximal lumen exit
Approximately 12mm from tip
Radiopaque markers
Distal 1mm from tip | Proximal 11mm from tip
Hydrophilic coating
Distal 18cm
Positioning marks
95cm (single) and 105cm (double) from distal tip
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete
regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires
and other interventional devices, and for use during two guidewire procedures. The Twin-Pass catheter is also
used to subselectively infuse/deliver diagnostic or therapeutic agents.
Simultaneous Measurement
of Differential Pressures
Outer lumen for AO/proximal pressure
Inner lumen for LV/distal pressure or
high pressure contrast delivery
Model
Description
Total
Length
Working
Length
O.D.
Inner
Lumen
Proximal
Marker Band
Guidewire
# Outer Lumen
Sideholes
# Inner Lumen
Sideholes
Inner Lumen
M.P.R.2
Max Flow Rate3
Box
Quantity
5515
145° Pigtail
125cm
117cm
7F
5F
0
≤0.038"
8
5
1200psi
17ml/s
5
5540
145° Pigtail
110cm
102cm
6F
5F1
0
≤0.038"
8
5
1000psi
13ml/s
5
5545
145° Pigtail, 5 marker bands
125cm
117cm
6F
5F1
5
≤0.038"
8
5
1000psi
12ml/s
5
5550
Multipurpose A2
102cm
95cm
6F
4F
0
≤0.038"
8
2
1000psi
14ml/s
5
Packaged in quantities of 5 units per box. Individual units are not sold separately.
1
5F Pigtail section with 4F shaft.
2
Maximum pressure rating.
3
Flow rates achieved at 4.7cP. Actual results may vary.
Each LANGSTON dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for
simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining
transvalvular, intravascular and intraventricular pressure gradients.
ASPIRATION
CATHETERS
A S P I R AT I O N CAT H E T E R S
Powerful Aspiration
and Superior Kink Resistance
Uniformly large extraction lumen
Embedded longitudinal wire
Silva® tip for vessel protection
Model
Description
Guide Catheter
Compatibility
Introducer Sheath
Compatibility
Guidewire Compatibility
Minimum
Vessel Size
Working Length
Box Quantity
4005
Pronto V4 Extraction Catheter 5.5F
6F (≥0.066")
5F
0.014"
(0.036mm)
1.75mm
(0.068")
138cm
1
4006
Pronto V4 Extraction Catheter 6F
6F (≥0.070")
5F
0.014"
(0.036mm)
2.00mm
(0.078")
138cm
1
4007
7F (≥0.078")
6F
0.014"
(0.036mm)
2.25mm
(0.088")
138cm
1
4008
8F (≥0.088")
7F
0.014"
(0.036mm)
2.50mm
(0.098")
138cm
1
17 | A S P I R AT I O N CAT H E T E R S
The Pronto V4 extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in
the coronary and peripheral vasculature.
Deliverability in Design
Maximized thrombus aspiration
Impressive deliverability
Silva tip for vessel protection
Model
Description
5003
Pronto V3 Extraction Catheter
Guide Catheter Compatibility
Guidewire
Compatibility
Working Length
Rapid Exchange Section
Box Quantity
≥6F (0.070" min. I.D.)
≤0.014"
140cm
20cm
1
The Pronto V3 extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in
the coronary and peripheral vasculature.
Low-Profile Aspiration
Powerful extraction in vessels ≥1.5mm in diameter
Removable stylet for kink-resistant delivery
5F option for 5F guide compatibility
Model
Description
Guide Catheter Compatibility
Guidewire Compatibility
Working Length
Rapid Exchange Section
Box Quantity
5010
Pronto LP Extraction Catheter
≥6F (0.066" min. I.D.)
≤0.014"
140cm
20cm
1
5015
Pronto LP 5F Extraction Catheter
≥5F (0.056" min. I.D.)
≤0.014"
138cm
25cm
1
The PRONTO LP catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the
coronary and peripheral system.
10F Power in Aspiration
Large vessel thrombus extraction
Silva tip vessel protection
Model
Description
Introducer Sheath Compatibility
Guidewire
Compatibility
Overall Length
Working Length
Marker Band
Syringes
Box Quantity
5040
Pronto .035" Extraction Catheter
(Mexico and Brazil Only)
≥10F (0.132"/3.35mm min. I.D.)
≤0.035"
127cm
115cm
Located ≈4mm from
the distal tip
One locking 60ml
polycarbonate
1
5041
Pronto .035" Extraction Catheter
≥10F (0.132"/3.35mm min. I.D.)
≤0.035"
127cm
115cm
Located ≈4mm from
the distal tip
One locking 60ml
polycarbonate
1
The Pronto .035" is indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the
arterial system, the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous
system, the removal/aspiration of embolic material (thrombus/debris) from the main pulmonary artery and its
branches as a treatment for acute pulmonary embolism in patients not eligible for surgical or lytic therapy and
to infuse/deliver diagnostic or therapeutic agents. Pronto .035" is not approved for the pulmonary application in
Mexico, Brazil and Canada.
8F & 14F Aspiration
Maximized extraction lumen for large vessels
Aspiration control
Model
Description
Tip Style
Introducer Sheath
Compatibility
Guidewire
Compatibility
Working
Length
Straightened
Pigtail Length
Marker Bands
Syringes
Box Quantity
5082
Pronto XL 8F
Extraction Catheter
Straight
≥8F
≤0.035"
120cm
N/A
Two located on each side of
extraction opening
Two locking 60ml
polycarbonate
1
5083
Pronto XL 8F
Extraction Catheter
Pigtail
≥8F
≤0.035"
120cm
122.5cm
extraction opening
Two locking 60ml
polycarbonate
1
5092
Pronto XL 14F
Extraction Catheter
Straight
≥14F
≤0.035"
120cm
N/A
extraction opening
Two locking 60ml
polycarbonate
1
5093
Pronto XL 14F
Extraction Catheter
Pigtail
≥14F
≤0.035"
120cm
122.5cm
extraction opening
Two locking 60ml
polycarbonate
1
EU: The Pronto 8F and 14F XL extraction catheters are indicated for the removal/aspiration of embolic material
(thrombus/debris) from vessels of the arterial system, the removal/aspiration of embolic material (thrombus/
debris) from vessels of the deep venous system, the removal/aspiration of embolic material (thrombus/debris)
from the main pulmonary artery and its branches as a treatment for acute pulmonary embolism in patients not
eligible for surgical or lytic therapy and to infuse/deliver diagnostic or therapeutic agents.
Simple Aspiration
for Dialysis Declot
40cm working length
6F introducer sheath compatibility
Model
Description
5030
Pronto-Short Extraction Catheter
Introducer Sheath
Compatibility
Guidewire
Compatibility
Overall
Length
Working Length
Marker Band
Syringes
Box Quantity
≥6F (0.070" min. I.D.)
≤0.018"
44.5cm
40cm
Located ≈3mm from
the distal tip
Two locking 30ml
polycarbonate
1
The Pronto-Short extraction catheter is indicated for the removal/aspiration of embolic material (thrombus/
debris) from vessels of the arterial system. The removal/aspiration of thrombus from clotted synthetic dialysis
grafts and arteriovenous fistulas.
ELECTROPHYSIOLOGY
E L E CT R O P H YS I O LO GY
Precise Wire Delivery for Left
Ventricle Lead Placement
Navigate extreme angulation
Cannulate tortuous anatomies
Subselective vein access
Model
Guidewire
Compatibility
Guide Catheter
Compatibility
Working
Length
Radiopaque Tip
Distal Tip Entry
Profile
Deflectable Tip O.D.
Proximal O.D.
I.D.
Box Quantity
5822
Venture CS (Coronary Sinus)
0.014"
6F (1.7mm)
70cm
8mm
1.8F (0.61mm)
2.2F (0.74mm)
4F (1.32mm)
0.018" (0.46mm)
1
See Original Venture Catheter on page 10
24 | E L E CT R O P H YS I O LO GY
The Venture catheters are indicated for directing, steering, controlling, and supporting a guidewire to access
discrete regions of the coronary and peripheral vasculature. The Venture CS catheters may also be used for
manual delivery of saline solution or diagnostic contrast agents.
EMBOLIZATION
E M B O L I Z AT I O N
Bioresorbable Gelatin Spheres
Sized for targeted occlusion
Smooth embolic delivery
Predictable distribution
Sphere Size
Minimum Catheter I.D.
Label Color
Box
Quantity
3800
100-300µm
0.020"
Yellow
5
3801
300-500µm
0.020"
Blue
5
Model
3802
500-700µm
0.023"
Red
5
3803
700-1000µm
0.038"
Green
5
26 | E M B O L I Z AT I O N
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
GUIDEWIRES
GUIDEWIRES
350cm Guidewire
for Extended Delivery
Nitinol core for flexibility and kink-resistance
5cm gold-plated tungsten coil for radiopacity
Model
Length
Guidewire Diameter
Mandrel
Coil
Box Quantity
7390
350cm
0.013"
Nitinol
Gold-plated Tungsten
5
28 | G U I D E W I R E S
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other
interventional devices within the coronary and/or peripheral vasculature.
CE Mark is pending. R350 guidewire is not available for sale in the EU.
HEMOSTASIS
H E M O STA S I S
Proven to Reduce Time-to-Hemostasis
Topical hemostat with the power of thrombin
Clinical results from a 376-patient, five‑center, prospective
randomized U.S. clinical study1 evaluating D-Stat Dry
as an adjunct to hemostasis in diagnostic femoral
catheterizations using 4F-6F introducer sheaths
compared to standard manual compression (control).
Time-To-Hemostasis (TTH) Results
Median TTH (mins)
Mean TTH (mins)*
± Standard Deviation
Range (min, max)
Treatment Group
D-Stat Dry (n=187)
Control (n=189)
6.0
12.0
7.8
13.0
3.0
6.4
6, 22
6, 31
*p-value of 0.001 calculated using Wilcoxon’s Rank-Sum Test
1
Hallak OK, Cubeddu RJ, Griffith RA, Reyes BJ. The use of the D-Stat® Dry Bandage for the control of vascular access
site bleeding: a multicenter experience in 376 patients. Cardiovasc Intervent Radiol. 2007 Jul-Aug;30(4):593-600.
Model
Description
3000
D-Stat Dry Topical Hemostat
The D-Stat Dry is contraindicated in persons with known sensitivity to bovine-derived materials.
Box Quantity
10
The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface
bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in
patients undergoing diagnostic endovascular procedures utilizing 4-6F introducer sheaths.
The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time
(PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin
and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies
against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or
abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be
re-exposed to these products.
30 | H E M O STA S I S
H E M O STA S I S
Ready-to-Deliver Gelatin Foam Pledgets
Assists in achieving hemostasis
Tantalum coated tip adds radiopacity for relocating biopsy sites
Available in multiple sizes for 14 – 20G coaxial biopsy needles
Model
Pledget Gauge Size
Hub Color
Pledget O.D.*
Box Quantity
4514
14G
Green
2.15mm
5
4516
16G
Purple
1.60mm
5
4518
18G
Pink
1.30mm
5
4520
20G
Yellow
0.90mm
5
Four pledgets are included in each device.
*Compressed dimension, swells upon contact with fluid.
The Hunter biopsy sealing device is contraindicated in persons with known hypersensitivity to porcine products.
The Hunter biopsy sealing device is intended for use in percutaneous liver biopsy procedures to facilitate
hemostasis of the biopsy tract and, if desired, mark the biopsy site with a radiopaque marker to help relocate the
site for subsequent intervention or diagnosis.
H E M O STA S I S
Bioresorbable Gelatin Pledget
for Transhepatic Tract Closure
Convenient, pre-loaded delivery system
Two radiopaque markers identify pledget position to ensure precise delivery
Flexible shaft for easy maneuverability through existing sheath
Model
Working Length
Compatible Sheath Length
Shaft O.D.
Compatible Sheath French Size
Pledget Length
Box Quantity
3930
20.5cm
≤13cm
0.048" (2.13mm)
6F-9F
4cm
5
The Hep-Plug sealing device is intended for use in percutaneous transhepatic procedures to seal the tissue tract.
INTERVENTIONAL
ACCESSORIES
INTERVENTIONAL
AC C E S S O R I E S
Maintains Hemostasis
during Interventions
8F inner lumen
Star-shaped seal
Designed for multiple interventional devices
Model
Description
FH101
Guardian II with Guidewire Insertion Tool
25
FH101-T
Guardian II with Guidewire Insertion Tool and Torque Device
25
FH101-25
Guardian II with Guidewire Insertion Tool, Torque Device and 25cm Sidearm Extension Tube
25
FH101-50
Guardian II with Guidewire Insertion Tool, Torque Device and 50cm Sidearm Extension Tube
25
Guardian II NC with Guidewire Insertion Tool
25
FH102
Box Quantity
FH102-T
Guardian II NC with Guidewire Insertion Tool and Torque Device
25
FH102-25
Guardian II NC with Guidewire Insertion Tool, Torque Device and 25cm Sidearm Extension Tube
25
FH102-50
Guardian II NC with Guidewire Insertion Tool, Torque Device and 50cm Sidearm Extension Tube
25
The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or
interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/
interventional devices with outside diameters up to 8F (0.105" or 2.67mm) during diagnostic/interventional
procedures.
The torque device is provided as an aid for steering the guidewire within the vascular anatomy.
The sidearm extension tubing included is provided to extend the sidearm of the Guardian II or Guardian II NC
hemostasis valve.
34 | I N T E RV E N T I O N A L AC C E S S O R I E S
RADIAL ACCESS
R A D I A L AC C E S S
More than Just a
Radial Compression Band
Power of thrombin
Single-operator pressure adjustments
Adjustable foam pads
Model
Description
3501
D-Stat Radial Topical Hemostat
The D-Stat Radial is contraindicated in persons with known sensitivity to bovine-derived materials.
Box Quantity
10
The D-Stat Radial is applied topically and is indicated for the control of surface bleeding from vascular access sites
and percutaneous catheters or tubes.
The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time
(PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin
and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies
against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or
abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be
re-exposed to these products.
36 | R A D I A L AC C E S S
SNARES
SNARES
The Only 0.014" Compatible
Guidewire-Based Snare
Delivery through microcatheters and balloon catheters
Open & use deployment
Unique locking handle
Model
Loop Diameter
Length
O.D.
Box Quantity
6500-002
2mm
180cm
0.014"
1
6500-004
4mm
180cm
0.014"
1
6500-007
7mm
180cm
0.014"
1
38 | S N A R E S
The MICRO Elite Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels
of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning
of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral,
neurovascular and cardiovascular system.
SNARES
Single Helical Loop
0.035" Compatible Guidewire-Based Snare
One-piece construction
Longer reach than right angle loops
Capture in all directions
Model
Loop Diameter
Length
O.D.
Box Quantity
6600-005
5mm
150cm
0.035"
1
6600-010
10mm
150cm
0.035"
1
6600-015
15mm
150cm
0.035"
1
6600-025
25mm
150cm
0.035"
1
6600-035
35mm
150cm
0.035"
1
39 | S N A R E S
The EXPRO Elite Snares are intended for use in the cardiovascular system and hollow viscus to retrieve and/or
manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/
or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the
cardiovascular system.
VEIN TREATMENT
V E I N T R E AT M E N T
Clinically Proven 810nm
Wavelength Laser Console
Transportable 15W console
Non-proprietary SMA-905 connector
Real-time readout and audible tone options
Class 4 laser
product
Visible and invisible laser radiation
Avoid eye or skin exposure to
direct or scattered radiation
Class 4 laser product
Wavelength 810nm Max output power 20W
Aiming Wavelength 635nm Max power 5mW
[IEC 60825-1 Ed.2 (2007)]
Vari-Lase Laser Console
Model
Description
7555
Vari-Lase 810nm Laser Console
Specifications
Laser wavelength: Output power: Operating modes:
Aiming beam:
810nm
1-15W
Continuous, pulsed
635nm; 5mW
Fiber connection: Non-proprietary SMA-905 connector
Cooling:
Air cooled
Power requirements: 110-240VAC, 50-60Hz
Weight: 4.5Kg (10lbs)
Vari-Lase Laser Console Accessories
Model
Description
7570
Laser Console Travel Case
7573
810nm Laser Protective Universal Overfit Eyewear with Case
7574
810nm Laser Protective Modern Wrap Around Eyewear with Case
7095
VacLok® Syringe, 30ml polycarbonate
41 | V E I N T R E AT M E N T
The Vari-Lase laser console is indicated for the medical treatment of varicose veins and varicosities associated
with superficial reflux of the Greater Saphenous Vein.
1470nm Wavelength Technology
15W endovenous laser console
Programmable physician settings for fast and easy set-up
Non-proprietary SMA-905 connector for use with any laser fiber
Class 4 laser
product
Visible and invisible laser radiation
Avoid eye or skin exposure to
direct or scattered radiation
Class 4 laser product
Wavelength 1470nm Max output power 20W
Aiming Wavelength 635nm Max power 5mW
[IEC 60825-1 Ed.2 (2007)]
Vari-Lase Laser Console
Model
Description
7576
Vari-Lase 1470nm Laser Console
Specifications
Laser wavelength: Output power: Operating modes:
Aiming beam:
1470nm
1-15W
Continuous, pulsed
635nm; 5mW
Fiber connection: Non-proprietary SMA-905 connector
Cooling:
Air cooled
Power requirements: 110-240VAC, 50-60Hz
Weight: 4.5Kg (10lbs)
Vari-Lase Laser Console Accessories
Model
Description
7570
Laser Console Travel Case
7577
1470nm Laser Protective Eyewear, Large Overfit with Case
7095
VacLok® Syringe, 30ml polycarbonate
The Vari-Lase laser console is indicated for the medical treatment of varicose veins and varicosities associated
with superficial reflux of the Greater Saphenous Vein.
Platinum Bright Tip Visibility
in a Low-Profile Design
Tip helps prevents inadvertent contact with vein wall
Low-profile for excellent deliverability
Model
Description
7169
Procedure Kit with 4F 12cm marked sheath and Platinum Bright Tip fiber (≤0.018" guidewire compatible)
4F 12cm marked sheath, 12cm marked Platinum Bright Tip fiber, 0.018" 40cm nitinol mandrel with stainless steel tip guidewire and 21G smooth tip needle
1
7170
1
7171
4F 45cm marked sheath, 45cm marked Platinum Bright Tip fiber, 0.035" 100cm guidewire with J-tip/Straight tip and 19G smooth tip needle
1
7172
1
7173
Procedure kit with 4F 70cm marked sheath and Platinum Bright Tip fiber (≤0.018" guidewire compatible)
1
7174
1
7180
4F 45cm marked sheath, 45cm marked Platinum Bright Tip fiber
1
7181
1
7182
1
7183
Procedure Kit with 4F 70cm marked sheath and Platinum Bright Tip fiber (≤ 0.035" guidewire compatible)
1
Box Quantity
The Vari-Lase procedure kits are indicated for the treatment of varicose veins and varicosities in the lower
extremity that are associated with superficial venous incompetency and reflux in the Great Saphenous Vein.
Better Point of View
Hands-free imaging
Up to 7mm below the skin’s surface
Completely portable
Model
Reference Number
7820
VEINSITE
7821
VTS1000-BAT10
7822
VTS1000-CHARGERS
7823
VTS1000-VGA10
Video Cable for Display Monitor
1
7824
VTS1000-CASE
Carrying Case
1
7825
VTS1000-PAD2PK-18
Headband Pad Sets (2 pack, 10 each)
20**
7826
VTS1000-PAD10PK
Headband Pad Sets (10 pack, 10 each)
100**
*Includes the Veinsite headset, 1 rechargeable battery, 1 battery charger, 1 carrying case,
1 set of replacement headbands and an operating manual.
**Individual units are not sold separately.
Manufactured for Vascular Solutions, Inc.
Description
Box Quantity
Veinsite Headset Vein Viewing System
*
1
Battery
1
Battery Charger
1
Veinsite is a non-invasive, electronic device to aid in the visualization of superficial, subcutaneous vasculature.
It is indicated for use in procedures requiring vascular or peripheral vessel access.
Easy Local Anesthesia Delivery System
Simple and efficient fluid delivery system
Multiple fluid doses without the need to manually reload the syringe
Includes polycarbonate control syringe,
IV extension line and three-way check valve
KIT COMPONENTS
• 12cc polycarbonate syringe (accuracy ±5%)
• IV tubing (108"/ 274cm) with spike, three-way check valve and roller clamp
• 36" (91.44cm) extension tubing
Model
Description
7600
Auto-Fill Syringe Kit
Devices packaged in quantities of 10 units per box. Individual units are not sold separately.
Please see the Instructions for Use for a complete listing of indications, contraindications,
Box Quantity
10
The Auto-Fill Syringe kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for
the purposes of local anesthesia.
Customer Service
Phone: (001) 763-656-4298
Fax: (001) 763-656-4251
Email: customerservice@vasc.com
Placing Purchase Orders
All orders should be directed to the Customer Service
department, Minneapolis, MN, United States by telephone,
fax or email. The Customer Service department is open
weekdays (excluding U.S. national holidays) between the
hours of 8:00am and 5:00pm (U.S. Central Time); however,
emergency assistance is available 24 hours a day. After
business hours, you may call Vascular Solutions to obtain
immediate assistance or leave a message (to be answered on
the next business day by the Customer Service department).
For after hours clinical emergencies, an on-call Vascular
Solutions clinical specialist can be paged by calling the
customer service number.
Corporate Office Locations
Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis, MN 55369
United States
Vascular Solutions Zerusa Limited
PMC Sierra Building
Galway Business Park
Dangan
Galway, Ireland
Website
www.vasc.com
Intended Product Usage/Storage
Most products in this catalog are supplied sterile and nonpyrogenic. Do not use any product if its sterile package is
damaged. Use sterile products prior to the “Use Before”
date.
Prior to use, refer to the Instructions for Use accompanying
the product.
Discard catheters and single use accessories after
one procedure. DO NOT REUSE OR RESHAPE. DO NOT
AUTOCLAVE SINGLE USE PRODUCTS. Structural integrity
and/or function may be impaired through reuse, reshaping
and cleaning. ACCORDINGLY, VASCULAR SOLUTIONS WILL
NOT BE RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM REUSE OF
PRODUCTS.
Product Complaints and Adverse Events
As a medical device manufacturer, Vascular Solutions has a
quality system procedure for the handling of adverse events
(also known as complaints). Adverse events related to any
Vascular Solutions product should be reported immediately
to Customer Service. All adverse events are entered into
Vascular Solutions’ complaint handling database to facilitate
tracking, trending and reporting. An interdisciplinary
team of Vascular Solutions employees will prepare an
46 | O R D E R I N G I N FO R M AT I O N
investigation plan and a follow-up plan for the adverse
event and determine if corrective action or other follow-up
is necessary.
Product Performance Return Policy
Vascular Solutions is committed to providing our customers
with quality products. For this reason, we will happily
accept any product for return that is a result of an error by
Vascular Solutions or does not perform to specification.
Authorization
Before a Vascular Solutions product is returned for credit
consideration, approval for the return must be obtained.
Authorization of a return can be requested by calling
Vascular Solutions’ Customer Service department: (001) 763656-4298. Upon approval of the return, Customer Service
will provide a return authorization (RA) number.
Return of Products
Once an RA number is acquired, products should be
returned postage prepaid in proper protective packaging to:
RA #__________
6464 Sycamore Ct. North,
Minneapolis, MN 55369
United States
If a product is returned without an RA number, Vascular
Solutions’ Customer Service department will not authorize
credit for, or replacement of, the product.
No allowance for, nor replacement of, defective goods
covered by warranty will be made unless the alleged defects
are established to the reasonable satisfaction of Vascular
Solutions. Any defective product must be returned to
Vascular Solutions within 14 days of discovery of defect in
order to receive any credit or replacement.
To receive credit for a product shipped by mistake of
Vascular Solutions the product must be returned in its
original unopened, unmarked packaging within 14 days
of receipt. Eligible products not returned within 14 days
of receipt may be accepted by Vascular Solutions in its
discretion, subject to a 20% restocking fee.
Product Returns
Products shipped and accepted by Buyer without error
or defect are not entitled to any right of return. Vascular
Solutions, in its discretion, may allow returns in certain
circumstances.
To be eligible for return consideration, the product must be
in its original packaging integrity (i.e., original ship unit).
Products will not be accepted if:
• Model is discontinued from sale
• Packaging is opened
• Packaging is damaged
• Product is used
• Product has less than 6-month shelf life
• Case is partial or incomplete
• Packaging has stickers or markings
Excusable Delays
Vascular Solutions is not responsible or liable for any delays
in the delivery of orders due in whole or in part, directly
or indirectly, to fire, act of God, strike, shortage of raw
materials, supplies or components, retooling, upgrading of
technology, delays of carriers, embargo, government order
or directive, or any other circumstance beyond Vascular
Solutions’ reasonable control.
Limited Warranty
Vascular Solutions warrants that its products are free
from defects in workmanship and materials at the date
of shipment. Liability under this warranty is limited to
refund or replacement of any product that has been
found by Vascular Solutions to be defective in materials or
workmanship. Vascular Solutions shall not be liable for any
incidental, special or consequential damages arising from
the use of its products. Damage to the product through
misuse, alteration, improper storage or improper handling
shall void this limited warranty.
No employee, agent or distributor of Vascular Solutions has
any authority to alter or amend this limited warranty in any
respect. Any purported alteration or amendment shall not
be enforceable against Vascular Solutions.
THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER OBLIGATION OF
VASCULAR SOLUTIONS.
Limitations
Under no circumstance will Vascular Solutions be liable
for any indirect, consequential, collateral, special or
incidental damages (including, without limitation, loss of
profits) with respect to any product or service provided
by Vascular Solutions, whether such claim is based on
contract, negligence, strict tort, warranty or any other basis.
Vascular Solutions’ liability may not, in any event, exceed
the purchase price of the particular product with respect to
which a claim is made.
Confidential Information
Buyer agrees that all information furnished in relation to the
purchase of products is proprietary to Vascular Solutions,
and Buyer must hold that information in confidence and
must not use, or permit disclosure to third parties of, that
information without Vascular Solutions’ prior written
consent.
No License
The sale by Vascular Solutions of its products does not
constitute a license, implied or otherwise, for the use of
any patents or know how of others or of Vascular Solutions
except in conjunction with the use of the Vascular Solutions
product involved.
47 | O R D E R I N G I N FO R M AT I O N
Applicable Law
Purchases of Vascular Solutions’ products are governed by,
and must be construed in accordance with, the substantive
laws of the state of Minnesota, without regard to the laws or
principles of any jurisdiction regarding conflict of laws.
Please see the Instructions for Use for a complete listing
of the indications, contraindications, warnings and
precautions for each product.
CAUTION: Vascular Solutions products should be used by
physicians with adequate training in the use of the products
and/or related procedures.
Vascular Solutions’ products and related procedures may be
covered by one or more U.S. and/or International patents.
Please see: www.vasc.com/products/patents.
Auto-Fill, D-Stat, GuideLiner, Langston, Minnie, PiggyBack,
Pronto, SmartNeedle, Turnpike, Twin-Pass, Vari-Lase and
Venture are registered trademarks of Vascular Solutions
within the United States. Guardian is a registered trademark
of Vascular Solutions Zerusa Limited within the United
States.
Expro Elite, Gel-Bead, Hunter, Micro Elite, Navigation,
Platinum Bright Tip, R350, SuperCross and Vasc Band are
trademarks of Vascular Solutions.
VacLok is a registered trademark of Merit Medical
Systems Inc. within the United States. Veinsite is a registered
trademark of VueTek Scientific LLC within the United States.
This catalog discusses products intended for
distribution in the following European Union countries:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, United
Kingdom, and Members of European Free Trade
Association: Iceland, Norway, Liechtenstein and
Switzerland. Availability in other countries may be
limited.
Regulatory approvals and indications for use
of certain products in some countries may
be restricted and/or limited.
©2016 Vascular Solutions, Inc. All rights reserved.
ML3158 Rev. A 02/16
6464 Sycamore Court North
Minneapolis, Minnesota 55369 USA
Customer Service:
Phone: (001) 763.656.4298
Fax: (001) 763.656.4251
Email: customerservice@vasc.com
www.vasc.com

Publication - Vascular Solutions

Transcription

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