English/Instructions for Use ........................................1

Vascular Solutions LLC

6464 Sycamore Court North

Minneapolis, MN 55369 USA

(866) 246-6990

(866) 804-9881

Teleflex Medical

IDA Business and Technology Park

Dublin Road, Athlone

Co. Westmeath, Ireland

GuideLiner® Coast™ Catheter

Instructions For Use

USA CAUTION

Federal law restricts this device to sale by or on the order of a

physician.

DEVICE DESCRIPTION

The GuideLiner catheter is a single lumen rapid exchange catheter

o󰀨ered in sizes compatible with 6F, 7F, and 8F guide catheters and

may be placed over a standard length guidewire. The larger sizes

of GuideLiner catheters are intended to be used within the proximal

portions of the coronary vasculature to provide support and/or

facilitate use of multiple interventional devices. The 150cm device

has a 125cm stainless steel shaft section covered on the distal 17cm

with a semi-circular polymer. The steel shaft is followed distally by a

25cm lumen section with the distal 22cm hydrophilic coated.

The GuideLiner catheter has two platinum-iridium marker bands,

which enable visibility while using standard uoroscopic methods.

The distal marker band is located on the distal tip. The proximal

marker band is located near the collar. The device has two

positioning marks located at 95cm (single mark) and 105cm (double

mark) from the distal tip.

The GuideLiner catheter is delivered through a guide catheter

resulting in an inner diameter that is approximately 1 French smaller

than the guide catheter. The GuideLiner catheter has a proximal

tab which indicates guide catheter compatibility and the resulting

GuideLiner catheter inner diameter.

The GuideLiner catheter has been sterilized with ethylene oxide.

Sterilized using

ethylene oxide

SPECIFICATIONS

Model

Compatible

Guide

Catheter

GuideLiner

Minimum I.D.

GuideLiner

Tip O.D. (X)

5270

5.5F

≥ 6F

(≥ 0.066" /

1.68mm I.D.)

0.051"

(1.30mm)

0.063"

(1.60mm)

5271

≥ 6F

(≥ 0.070" /

1.78mm I.D.)

0.056"

(1.42mm)

0.067"

(1.70mm)

5272

≥ 7F

(≥ 0.078"/

1.98mm I.D.)

0.062"

(1.57mm)

0.075"

(1.90mm)

5273

≥ 8F

(≥ 0.088" /

2.24mm I.D.)

0.071"

(1.80mm)

0.085"

(2.16mm)

95cm

4mm

105cm

MARKER

25cm

17cm

150cm

2mmx

INDICATIONS

GuideLiner catheters are intended to be used in conjunction with

guide catheters to access discrete regions of the coronary and/

or peripheral vasculature, to facilitate placement of interventional

devices, and to assist in crossing de novo coronary chronic total

occlusions (CTO).

CONTRAINDICATIONS

The GuideLiner catheters are contraindicated in vessels less than

2.5mm in diameter and in vessels in the neurovasculature or the

venous system.

WARNINGS

The GuideLiner catheter is provided sterile for single use only. Reuse

of single-use devices creates a potential risk of patient or user

infections and may compromise device functionality, which may lead

to illness or serious patient injury.

Never advance the GuideLiner catheter into a vessel without a

leading guidewire as vessel damage may result.

Never advance the GuideLiner catheter into a vessel with an

e󰀨ective diameter less than 2.5mm. Vessel injury and/or occlusion

may result. If pressure in a vessel dampens after inserting the

GuideLiner catheter, withdraw the catheter until the pressure returns

to normal.

Due to the size and non-tapered tip of the GuideLiner catheter,

extreme care must be taken to avoid vessel occlusion and damage

to the wall of the vessels through which this catheter passes.

Never advance or withdraw an intravascular device against

resistance until the cause of the resistance is determined by

uoroscopy. Movement of the catheter or guidewire against

resistance may result in separation of the catheter or guidewire tip,

damage to the catheter, or vessel damage.

PRECAUTIONS

Do not use the GuideLiner catheter if the packaging has been

damaged. A damaged package could result in a breach of sterility or

device damage.

Inspect the GuideLiner catheter prior to use for any bends or kinks.

Do not use a damaged catheter. Vessel damage and/or inability to

advance or withdraw the catheter may occur.

The catheter lumen should be ushed with sterile, heparinized saline

prior to use to prevent clot formation and to ensure the catheter is

free from debris which could be introduced into the body resulting in

an embolism and/or occlusion.

Precautions to prevent or reduce clotting should be taken when any

catheter is used in the vascular system.

Exercise care in handling of the catheter during a procedure to

reduce the possibility of accidental breakage, bending or kinking. Do

not apply torque to the catheter during delivery, as catheter damage

may result.

When the catheter is in the body, it should be manipulated only

under uoroscopy. Do not attempt to move the catheter without

observing the resultant tip response, as catheter damage or vessel

injury may occur.

Never advance the GuideLiner catheter more than 15cm beyond the

tip of the guide catheter as the GuideLiner catheter may become

lodged in the guide catheter making it di󰀩cult to remove.

Do not withdraw an undeployed stent back into the GuideLiner

catheter when the catheter is in the body, as it may result in

dislodging the stent. Instead, simultaneously pull both the GuideLiner

catheter and undeployed stent back into the guide and remove

together.

ADVERSE EFFECTS

Potential adverse e󰀨ects that may be associated with the GuideLiner

catheter include, but are not limited to, the following:

• Cardiac arrest

• Embolism

• Infection

• Myocardial infarction

• Slow-ow/Occlusion

• Stent dislodgement

• Thrombosis

• Vessel dissection

• Vessel perforation

CLINICAL SUMMARY

A prospective, multi-center, single-arm study of 150 subjects was

performed to evaluate the safety and e󰀨ectiveness of Vascular

Solutions’ specialized guidewires, microcatheters, and guide

extensions in patients undergoing CTO-PCI. The objective of the

study was to evaluate angiographic conrmation of placement of

any guidewire beyond the CTO, in the true vessel lumen, in patients

undergoing CTO PCI in which at least one study guidewire and one

Turnpike catheter were used.

Device Use

A total of 566 study-guidewires (55% of the total number of

guidewires used; used in all 150 subjects) and 457 non-study

guidewires (45% of the total; used on 112 subjects) were used in

the CTO-PCI Study. At least one Turnpike catheter and one study

guidewire were used in all cases, and a GuideLiner V3 catheter

(used in 16% of cases) or TrapLiner catheter was used in all cases

where a guide extension was required (64% of cases).

GuideLiner Coast was not used in the study. The di󰀨erences

between the GuideLiner Coast catheter and the GuideLiner V3

catheter are the hydrophilic coating, the ability to advance the device

an additional 5 cm beyond the tip of the guide catheter, and modied

hub materials.

Study device procedural technique is provided in the following table.

Procedural Technique – n (%)

Wire escalation 86 (57.3%)

Dissection/re-entry 23 (15.3%)

Wire externalization 21 (14.0%)

Safety 15 (10.0%)

Stabilization and/or support 7 (4.7%)

Delivery 5 (3.3%)

Reverse CART 4 (2.7%)

Crossing 2 (1.3%)

Not specied 2 (1.3%)

CTO RCA and RPL 1 (0.7%)

Donor vessel 1 (0.7%)

Knuckled 1 (0.7%)

Workshorse 1 (0.7%)

Baseline Demographics

Baseline demographics are provided in the following table.

Baseline Demographics

Characteristics N=150¹

Gender

Female 23 (15.3%)

Male 127 (84.7%)

Age (years) at enrollment

Mean ± SD 65.4 ± 10.8

Range 37.1 - 91.8

Race/Ethnicity

White 130 (86.7%)

Black or African American 8 (5.3%)

Native Hawaiian or Other Pacic Islander 1 (0.7%)

Asian 4 (2.7%)

Unknown or not reported 7 (4.7%)

Non-Hispanic/Latino/Spanish origin 139 (92.7%)

Hispanic/Latino/Spanish origin 7 (4.7%)

Ethnicity unknown or not reported 4 (2.7%)

¹Includes data from ve subjects who were enrolled twice in the

study, for the treatment of separate de novo CTO lesions.

Primary Endpoints

The primary endpoint for the study was dened as procedure

success through discharge or 24 hours post-procedure, whichever

came rst. Procedure success was dened as angiographic

visualization of any guidewire in a position either distal or proximal

to the occlusion depending on the route of access, and absence of

in-hospital MACE (cardiac death, target lesion revascularization, or

post-procedural MI dened as CK-MB ≥ 3x ULN).

Summary of Primary Endpoints

The study primary endpoint result (75.3%) met the predetermined

performance goal.

Category Study Results %

(n/N)

Overall Primary Endpoint Met 75.3% (113/150)

Components of Primary Endpoint

Angiographic Visualization of any

guidewire distal/proximal to CTO in the

true vessel lumen

94.7% (142/150)

Absence of in-hospital MACE 80.7% (121/150)

Secondary Endpoints

The secondary endpoints include:

• Frequency of successful recanalization (dened as

angiographic conrmation of crossing CTO and restoring

blood ow to the a󰀨ected area).

• Frequency of MACE through discharge or 24 hours post-

procedure, whichever comes rst (in-hospital follow-up),

and at 30 days post-procedure (MACE components are also

reported separately).

• Frequency of clinically signicant perforation (dened as

any perforation resulting in hemodynamic instability and/

or requiring intervention including pericardiocentesis,

embolization, prolonged balloon occlusion, stent graft, or

comparable therapy).

• Procedural success according to crossing technique.

• Technical success.

Summary of Secondary Endpoints

Category Study Results %

(n/N)

Successful recanalization 140 (93.3%)

MACE 29 (19.3%)

In-Hospital 29 (19.3%)

30-Day 0 (0.0%)

Clinically Signicant Perforations 16 (10.7%)

Procedure success by Crossing Technique

Antegrade 69 (85.2%) (69/81)

Retrograde 1 (50.0%) (1/2)

Combined Antegrade and Retrograde 43 (64.2%) (43/67)

Technical Success 140 (93.3%)

MACE includes all MIs dened as CK-MB ≥ 3x ULN

Summary of Adverse Events

The most common study device- and/or procedure-related AEs were

myocardial infarction (19.3% of the subjects), vessel perforation

(13.3% of the subjects) and coronary artery dissection (9.3% of the

subjects).

Category Study Results % (n/N)

In-Hospital MACE 29 (19.3%)

Cardiac Death 1 (0.7%)

Target lesion revascularization 1 (0.7%)

Post-Procedural MI (CKMB ≥

3 x ULN) 27 (18.0%)

Post-Procedural MI (CKMB ≥

10 x ULN) 9 (6.0%)

30-Day MACE 0 (0.0%)

Perforations

All Perforations 21 (14.0%)

Clinically Signicant

Perforations 16 (10.7%)

Class I 3 (2.0%)

Class II 10 (6.7%)

Class III 8 (5.3%)

Dissection

NHLBI Class A 3 (2.0%)

NHLBI Class B 2 (1.3%)

NHLBI Class C 2 (1.3%)

NHLBI Class D 3 (2.0%)

NHLBI Class E 1 (0.7%)

NHLBI Class F 0 (0.0%)

Conclusion

In a multicenter, prospective registration trial, procedural success

was achieved in a high lesion complexity patient population (e.g.,

94.7% severely calcied lesions) using contemporary technique and

application of dedicated CTO guidewires, microcatheters and guide

catheter extensions

CLINICAL PROCEDURE

The GuideLiner catheter should be used by physicians trained on the

procedures for which it is intended. The techniques and procedures

described do not represent ALL medically acceptable protocols, nor

are they intended as a substitute for the physician’s experience and

judgment in treating any specic patient. All available data, including

the patient’s signs and symptoms and other diagnostic test results,

should be considered before determining a specic treatment plan.

PACKAGE CONTAINS:

1x Catheter

OTHER ITEMS REQUIRED BUT NOT PROVIDED:

• Guide catheter with an inner diameter large enough to

accommodate the specic model of GuideLiner catheter in

use

• Y-adaptor with hemostasis valve (Tuohy-Borst type)

• Guidewire with diameter ≤ 0.014" / 0.36mm

• Sterile syringe (for ushing)

• Sterile heparinized saline (for ushing)

PREPARATIONS FOR USE

1. Prior to use, carefully inspect the GuideLiner packaging and

components for damage.

2. Using sterile technique, transfer the dispenser coil with the

GuideLiner catheter into the sterile eld.

3. Remove the GuideLiner catheter from the dispenser coil and

thoroughly ush the lumen of the GuideLiner catheter from the

distal tip with sterile, heparinized saline solution.

4. Wet the distal section of the catheter with heparinized saline

to activate the catheter's hydrophilic coating.

DEPLOYMENT PROCEDURE

Deploy the GuideLiner catheter according to the following steps:

1. Secure the previously inserted guidewire and backload the

distal tip of the GuideLiner catheter onto the guidewire and

advance until the catheter is just proximal to the hemostasis

valve.

2. Open the hemostasis valve and advance the GuideLiner

catheter through the hemostasis valve and into the guide

catheter.

3. Under uoroscopy, advance the GuideLiner catheter beyond

the distal tip of the guide catheter and into the desired location

within the vessel.

WARNING: Never advance the GuideLiner catheter into a

vessel with an e󰀨ective diameter less than 2.5mm. Vessel

injury, ischemia, and/or occlusion may result. If pressure

in a vessel dampens after inserting the GuideLiner

catheter, withdraw the catheter until the pressure returns

to normal.

WARNING: Due to the size and non-tapered tip of the

GuideLiner catheter, extreme care must be taken to avoid

vessel occlusion and damage to the wall of the vessels

through which this catheter passes.

4. Using uoroscopy, conrm the desired position of the

GuideLiner catheter in the vessel.

5. If performing an interventional procedure, backload the

interventional device over the existing guidewire and advance

the device through the guide catheter and GuideLiner catheter

into the desired vascular space.

NOTE: If a second wire is used during the intervention

and encounters resistance within the guide catheter, pull

the wire back several centimeters and slowly readvance.

6. Tighten the Y-adaptor hemostasis valve securely on the

proximal shaft of the GuideLiner catheter to prevent back-

bleeding.

7. Perform the catheterization procedure. After completing the

procedure, remove the GuideLiner catheter prior to removing

the guide catheter from the vessel.

8. Dispose of the GuideLiner catheter following standard hospital

procedures.

STORAGE & HANDLING

No special storage or handling conditions.

LIMITED WARRANTY

Vascular Solutions LLC warrants that the GuideLiner catheter is

free from defects in workmanship and materials prior to the stated

expiration date. Liability under this warranty is limited to refund or

replacement of any product, which has been found by Vascular

Solutions LLC to be defective in workmanship or materials. Vascular

Solutions LLC shall not be liable for any incidental, special or

consequential damages arising from the use of the GuideLiner

catheter. 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 LLC 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 LLC.

THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER

WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY

WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE OR ANY OTHER OBLIGATION OF

VASCULAR SOLUTIONS LLC.

PATENTS AND TRADEMARKS

May be covered by one or more U.S. or international patents.

See: www.teleex.com/patents-intv

Teleex, the Teleex logo, GuideLiner, and Coast are trademarks or

registered trademarks of Teleex Incorporated or its a󰀩liates in the

U.S. and/or other countries.

See the International Symbols Glossary on page 3.

See the Content Glossary on page 4.

International Symbols Glossary

Phone Number

Fax Number

Guide catheter

inner diameter

GCID

GuideLiner

inner diameter

GLID

International Symbols Glossary Phone

number

Fax number Guide catheter

inner diameter

GuideLiner inner

diameter

Medical device Catalogue

number

Non-pyrogenic Do not re-use Do not use if package

is damaged

Caution, consult

accompanying

documents

Rx ONLY

UDI

Manufactured by

International Symbols Glossary Caution, consult

accompanying

documents

Prescription Use

Only

Sterilized using

ethylene oxide

Unique Device

Identication

Single sterile

barrier system

Use-by date Batch code Manufacturer

Content Glossary

Content Glossary GuideLiner Catheter