Guide wire & Guide catheter!

PTCA Guidewires

PTCA Guidewires

One of the most difficult Interventional products to convert due to its physicians “personal” relationship with their wire of choice.

PTCA Guidewire Functions

PTCA Guidewires are designed to:Access to a lesion“Atraumatically” cross a lesionProvide device delivery supportProvide unhampered device movementUnobstructed lesion visualization

(radiopacity)

Guide wire Characteristics

Tip Trackability Tip softness Ease of tip forming Tip Shape retention

Radiopacity Wire Steering in

anatomy PCI device support PCI Device

trackability

Design trade-offs occur when one of these characteristics are out of balance

Guidewire Overview

Guidewire Construction Coatings Extension Systems

Core Wire

Core Wire: Stainless Steel or Stainless Steel/Nitinol wire (Fusion/BMW family)

The series of barrels and tapers (or transitions), with varying lengths and diameters determine many of the key performance characteristics of the wire

Guidewire Construction Design

Support wire for device delivery (stents)

POBA (balloons)

Crossing Wire-CTO’s

Two Barrel

Single Barrel

Tapered Barrel

Trade-offs

If you have more wire supportStraightens vesselsMore vessel contact during device advancement

increases resistance during advancement

May be the only option for stiff device delivery

If you have less wire support•Conforms to the natural curves in the anatomy•Requires more trackable devices (balloons)•Safer ?

Outer Covering: Spring(s)Helical Coil is wound from Stainless Steel. To provide desired radiopacity the distal tip is either Stainless Steel with gold Markers or more commonly made of Platinum.The Coil fills out the body of the wire “0.014”.

Spring (s)

Forming Ribbon Tip DesignFlat stainless steel wire extending from the distal core wire designed to provide:

-Tip softness

-Tip shape retention/tip shaping

-Tip trackability/prolapsability

SpringsCore wireForming ribbon

Coatings

Reduce friction during wire placement and device delivery

TypesPTFE (Teflon)Silicone (Pro/Pel)Hydrophilic (Hi-Per Coat)

Extension/Exchange Area

Medtronic AVE: Linx – EZ & DocACS: Doc, AnchorCordis: CinchSciMed: Magnet

Challenges of Coronary GW

CTO - Chronic Total Occlusions Vessel Tortuosity Device Delivery

CTO Technique

Operators may start with soft wire Increase tip stiffness incrementally by

trading up wire type Advance balloon closer to wire tip Increase distal vessel visualization by

contralateral Angiography

WiringTechniques

Track Straight Turn/Steer

Guidewire Induced Vessel Straightening

Medtronic AVE PTCA Guidewires

GT2 Fusion GT1 Product Line

Floppy Direct Light Support Support

Hi Per Flex Standard

Factors for Selling Success Know your Doctor’s Preferences

Lucent vs. Opaque“Steerer” vs. “Driver”Support vs. FloppyOne Wire vs. Start Wire/Stent WireRx vs. OTWDevices used in lab (I.e. stents, Rotablator,

DVI, IVUS, etc.)

Medtronic AVE Guidewires

Floppy

Direct

Light Support

Support

GT1 Product Line

Start-to-Finish Performance

Confident access and crossSuperior vessel trackingMaximum push and torque efficiency

Endurance and supportNitinol always “in shape” throughout the caseDevice support from POBA to stentingOptimal in-device wire movement

Union of Technology-Tip to Tail Atraumatic forming ribbon tip design Spring length

25 cm distal spring/3 cm radiopaque length 45 cm Nitinol core wire segment Single-joint, stainless steel, hypotube shaft

supporting Nitinol 180 cm DOC* Compatible/300 cm Pro/Pel silicone-type coating *DOC ®is a registered trademark of Guidant Corporation.

Design Features & Benefits

Nitinol-to-stainless-steel constructionKink-resistant NitinolNitinol memory durability throughout the caseStainless steel hypotube strength and torqueSuperior push efficiencyOutstanding torque transmission

Design Features & Benefits

Precision core wire and tip geometryTip softnessVessel trackingDevice support

A Powerful Union Single-joint design

Joint location in the straight segment of the guide

Provides seamless, transition for device delivery

Enhances torque transmission to the distal Nitinol segment

Superior torque transmission Optimal wire movement

Innovative Hypotube Design

Nitinol and stainless steel are joined 45 cm from the distal tip,ensuring that the joint location is in the straight segment of the guiding catheter

Fusion vs. BMW

Fusion Similarities Nitinol/Stainless steel

construction Forming ribbon tip 3 cm radiopaque length 25 cm spring DOC® Extension-

compatible

•Fusion Differences-Hypotube enhances torque transmission-Single joint attachment process-Superior distal vessel tracking-Distal tip column support-Pro/Pel silicone coating

Distal Tip Comparisons

The Fusion guidewire distal tip design offers ideal,workhorse tip support while minimizing tip stiffness.

Outstanding Torque Response

Fusion’s stainless steel hypotube shaft offers outstanding torque transmission for improved steering capability

Torque Response:It ’s all in the Physics!

Torque forces applied to ahollow tube are transmittedmore efficiently due to asmaller cross-sectional area

Standard (Steerable) 0.014” and 0.016” diametersCore to tipPTFE or Silicone Coatings ‘J’ tip and 180cm onlyTotal occlusion (CTO) wire, very stiff tip

Other Medtronic AVE PTCA Guidewires

Competitive Overview

Market TrendsCompetitive Products

PTCA Guidewire Market

OTW to RX balloons = 300 cm (exchange) to 180 cm (standard) length trend

Stent trackability Wire support needed Purchasing contracts = more compliance

and fewer choices for physician

PTCA Guidewire Competitors

ACS/Guidant SciMed/Boston Scientific Cordis/J&J Medtronic AVE

Top Selling Wire Brands ACS Balance Wires (BMW and BHW) ACS Support Wires (S’port, All-Star, Support) ACS Hi-Torque Floppy II SciMed Choice Extra SupportCordis Stabilizer XSCordis ATWMedtronic AVE

Factors for Selling Success

Knowledge of ProductHow your wires differ/similarTranslation of design feature into performance

benefit Knowledge of Competitors’ Product

How is yours different, thus better!

Summary Know your products Know your competitors’ products Know your account targets’

Wire preferencesCurrent product used and likes and dislikesContract status and compliance

Functions of a Guide Catheter

• The main functions of a Guide Catheter:

• Conduit for contrast, wire & device transport

• Support for device advancement

Relevant Anatomy

RCA

LCA or Left Main

LAD

LCXCusp of the heart’s Aortic valve

Descending Aorta

Ascending Aorta

Coronary Anatomy

The point at which the ostium of the RCA or LCA is attached to the aortic root can vary.

Right Coronary Ostia

Left Coronary Ostia

Sinuses of Valsalva

Ascending Aorta

• Left Cusp

•Right Cusp•Posterior Cusp

Aortic Valve

Cut away view of Aorta & flattened

RCA

LCA or Left Main

LAD

LCX

Cusp of the heart’s Aortic valve

Ascending Aorta

Coronary Anatomy

Access Site Options

Femoral Approach Radial/ Brachial Approach

1- Heart2- Aorta3- Femoral Artery4- Radial Artery

Access Site Issues

Scar Tissue Tortuosity Surgical Graft Diseased Iliacs (PVD)

The Conduit to the Target Vessel

Important Features of a Guide Catheter

Atraumatic tip Preformed curves & configurations Torque control Kink resistance Radiopacity Support Device Compatibility

Guide Catheter Construction All Guide catheters have the same basic construction:

Primary Curve

Tip

Radiopaque Marker

ShaftStrain Relief

Hub/Luer

Secondary Curve

Guide Catheter Construction

I.D.O.D.Key Measurements:

6 French 7 French5 French 8 French

(1-French = 0.33 mm)

Catheters are named by their OD in French:

Guide Catheter Shaft Construction

Inner LinerStainless Steel braid

Outer jacket

Internal Lumen

Smooth or Lubricious

Material

Device Compatibility

1:1 Torque

Kink resistance

Strength

Support/ Flexibility

Kink resistance

Numerous curve configurations

Importance of Co-Axial Alignment

Coaxial or parallel alignment of the catheter will affect how well the guide catheter operates as a conduit

Non-Coaxial

Coaxial

Curve Selection Factors Anatomical Approach Access Site Issues French Size Influence Back-up Support Aortic Width Coronary Anatomy Native Coronary vs. CABG/IMA Location and Severity of Target Lesion Amount of Calcification in Target

Vessel

Types of Guide Catheter CurvesBroadly split into three categories:StandardStandard guides provide coaxial alignment for the majority of patients with relatively straight forward aortas and vessel orientation. These guides often ride above the sinuses or barely reach into the sinus. (JL, JR, LCB, RCB)

Support– Support guide catheters derive their support

primarily from the Sinus of Valsalva. (AL, AR, Hockey Stick)

Extra Support – Gather their support from the opposite wall

of the aorta (EBU)

Sizing based on Aortic Width

Narrow

Normal

< 3.5 cm

Dilated

> 4.0 cm3.5 - 4.0cm

Aortic Width Determines the Choice of Curve Length

3.04.0

5.0

Judkins Left

P

S

P = Primary Curve S = Secondary Curve

Curve Length = distance (cm) between P & S

Choice of Curve Length

Aortic Width Determines Curve Length

Judkins Right

S

3.04.0

5.0

P = Primary CurveS = Secondary Curve

P

Curve Length = distance (cm) between P & S

The Perfect FitProper fit is a 45o angle at the primary curve with coaxial alignment and the secondary curve buttressing against the contralateral wall

Curve Length Considerations

• Shorter curve:

• May be useful for vessels with superior orientation

Longer curve: May be useful for vessels

with inferior orientation

Tip Orientation

French Size Influence Historically, 8F guides were necessary to deliver devices

because of their larger internal lumens.

Current 6-7F catheters have internal lumens just as large as previous generation 8F catheters.

Small guides require ‘back-up” curves more frequently for added support.

Large guides require side-holes more frequently to improve perfusion.

French Size Influence

Better passive support

Better visualization

Better torque

transmission

Small arterial puncture

Brachial/radial access

Permit active support

Less contrast

PROS

Larger arterial puncture

Pressure dampening

More contrast

Smaller internal lumen

Less visualization

CONS

7-8F Guides6F Guides

6F = 2mm/0.79” OD 7F = 2.3mm/0.92” OD

8F = 2.7mm/0.105” OD

Perfusion of Target Vessel

Smaller Diameter catheters, such as a 5F or 6F allow for perfusion of the target vessel.

Larger diameter catheters such as 7F and 8F, or deep seated catheters may cut off perfusion of the target vessel. Side-holes in the guide help to alleviate this issue. Location for side holes

Deep-seating

Pressure Damping

Note: Side holes allow perfusion, but don’t prevent guiding catheter injury to the ostium

Normal Ventricularization Damped

Types of Catheter Support The ability of the guiding catheter to remain in position

and provide a stable platform for the advancement of interventional equipment.

There are three main types of catheter support: Active Support Passive Support Balanced Support

Distal Segment

Active Support Active Support users typically:

Use the artery itself to ensure guide curve conformability and back-up (deep seating)

Relies on active manipulation of guiding catheter to: Obtain stable position Seat coaxially Pre-select LAD or LCX

Passive Support Passive support users typically:

Rely on properties of the shaft and tip to maintain position in the ostium

Depend on Support provided by either anatomy or catheter composition/curve shape

Rarely deep-seat the catheter Prefer minimal manipulation of the guide catheter Prefer guides with a stiffer distal segment

Balanced Support Balanced support users typically:

Rely on properties of the shaft and tip to maintain position in the ostium but prefer a flexible distal segment that can be manipulated/seated for extra back up if needed

Choosing Types of Support

Requires precise curve selection and sizing Requires large Ostia

Requires

disease-free ostia

Active Support

No Yes Yes

Balanced Support

No Indeterminate Indeterminate

Passive Support

Yes Indeterminate Indeterminate

Soft Distal Segment

Firm Distal Segment

Active Balanced Passive

Four Families of Medtronic Guide Catheters

Active Support: Sherpa NX, Zuma 2 Balanced Support: Sherpa NX, Launcher Passive Support: Zuma

Launcher: Largest ID 6F (0.071”) Full Wall Technology

Sherpa NX: Consistent Lubricity Full Wall Technology Extra-Soft tip Choice of distal segment support in 6F

Over 240 curves on every platform Custom curves – made to order

Medtronic Guide Catheters

Note: Zuma and Z2 are still available, however Launcher and Sherpa are actively promoted as the latest guide catheter technology from Medtronic.

Full Wall Technology

Nylon liner and outer jacket fuse together through the flat wire braid

during extrusion process

• PTFE liner• Round/flat braid layer• Outer Jacket

Medtronic Guides at a Glance…

Sherpa NX Active Sherpa NX Balanced

Launcher Z2

French Size / ID

5: 0.058”

6: 0.070”

6: 0.070”

7: 0.080”

8: 0.088”

5: 0.058”

6: 0.071”

7: 0.081”

8: 0.090”

5: 0.058”

6: 0.070”

7: 0.081”

8: 0.091”

Primary Curve

Active: Soft Balanced: Flexible Flexible Flexible

Secondary Curve

Supportive Supportive Supportive Flexible

Liner HDPE HDPE Coated / Silicone Coated

Marker Band Yes, 3 mm proximal from tip

Yes, 3 mm proximal from tip

Yes, 3 mm proximal from tip

Yes, 3 mm proximal from tip

Distal Segment

Secondary Curve

Tip