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 lesion Provide device delivery support Provide unhampered device movement Unobstructed lesion visualization (radiopacity)

Guide wire Characteristics

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

Tip Trackability Tip softness Ease of tip forming Tip Shape retention

Radiopacity Wire Steering in anatomy PCI device support PCI Device trackability

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

Single Barrel

Support wire for device delivery (stents)

Two Barrel

POBA (balloons)
Tapered Barrel

Crossing Wire-CTOs

Trade-offs
If you have more wire support
Straightens

If you have less wire support

Conforms to the natural curves in the anatomy Requires more trackable devices (balloons) Safer ?

vessels More vessel contact during device advancement

increases

resistance during advancement

May

be the only option for stiff device delivery

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 Design

Flat stainless steel wire extending from the distal core wire designed to provide: -Tip softness
-Tip shape retention/tip shaping -Tip trackability/prolapsability
Core wire Springs Forming ribbon

Coatings
Reduce friction during wire placement and device delivery Types

PTFE

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

Extension/Exchange Area
AVE: Linx EZ & Doc ACS: Doc, Anchor Cordis: Cinch SciMed: Magnet
Medtronic

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

Wiring Techniques

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 Doctors Preferences

Lucent

vs. Opaque Steerer vs. Driver Support vs. Floppy One Wire vs. Start Wire/Stent Wire Rx vs. OTW Devices used in lab (I.e. stents, Rotablator, DVI, IVUS, etc.)

Medtronic AVE Guidewires

GT1 Product Line Floppy

Direct
Light Support Support

Start-to-Finish Performance

Confident access and cross

Superior

vessel tracking Maximum push and torque efficiency

Endurance and support

Nitinol

always in shape throughout the case Device support from POBA to stenting Optimal 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 construction
Kink-resistant

Nitinol Nitinol memory durability throughout the case Stainless steel hypotube strength and torque Superior push efficiency Outstanding torque transmission

Design Features & Benefits

Precision core wire and tip geometry

Tip

softness Vessel tracking Device 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 Differences

Fusion Similarities
Nitinol/Stainless

steel

construction Forming ribbon tip 3 cm radiopaque length 25 cm spring DOC Extensioncompatible

-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

Fusions stainless steel hypotube shaft offers outstanding torque transmission for improved steering capability

Torque Response: It s all in the Physics!

Torque forces applied to a hollow tube are transmitted more efficiently due to a smaller cross-sectional area

Other Medtronic AVE PTCA Guidewires

Standard (Steerable)
0.014

and 0.016 diameters Core to tip PTFE or Silicone Coatings J tip and 180cm only Total occlusion (CTO) wire, very stiff tip

Competitive Overview
Market

Trends Competitive 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 (Sport, All-Star, Support) ACS Hi-Torque Floppy II SciMed Choice Extra Support Cordis Stabilizer XS Cordis ATW Medtronic AVE

Factors for Selling Success

Knowledge of Product
How

your wires differ/similar Translation 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

preferences Current product used and likes and dislikes Contract 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
Ascending Aorta Descending Aorta

LCA or Left Main RCA

LAD

Cusp of the hearts Aortic valve

LCX

Coronary Anatomy

The point at which the ostium of the RCA or LCA is attached to the aortic root can vary.
Ascending Aorta Left Coronary Ostia Left Cusp Posterior Cusp Right Cusp

Sinuses of Valsalva Right Coronary Ostia

Cut away view of Aorta & flattened

Coronary Anatomy
Cusp of the hearts Aortic valve

Ascending Aorta

LCA or Left Main LCX

RCA

LAD

Access Site Options

Femoral Approach Radial/ Brachial Approach

1- Heart 2- Aorta 3- Femoral Artery 4- 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:

Radiopaque Marker Tip Primary Curve

Hub/Luer

Strain Relief

Shaft

Secondary Curve

Guide Catheter Construction

Key Measurements: O.D. I.D.

Catheters are named by their OD in French: (1-French = 0.33 mm) 5 French 6 French 7 French 8 French

Guide Catheter Shaft Construction

Outer jacket Stainless Steel braid Inner Liner

Strength Support/ Flexibility Kink resistance

1:1 Torque Kink resistance

Internal Lumen Smooth or Lubricious Material Device Compatibility

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 Curves

Broadly
Standard
Standard

split into three categories:

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

< 3.5 cm > 4.0 cm 3.5 - 4.0cm

Narrow Normal

Dilated

Choice of Curve Length

Aortic Width Determines the Choice of Curve Length
S
Judkins Left
5.0 4.0 3.0

P
Curve Length = distance (cm) between P & S
P = Primary Curve S = Secondary Curve

Aortic Width Determines Curve Length

Judkins Right

S
3.0

P
4.0

5.0

Curve Length = distance (cm) between P & S

P = Primary Curve S = Secondary Curve

The Perfect Fit

Proper 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

6F Guides
PROS

7-8F Guides

Small arterial puncture Brachial/radial access Permit active support

Better passive support Better visualization Better torque transmission

Less contrast

CONS

Smaller internal lumen Less visualization

Larger arterial puncture Pressure dampening More contrast

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

Normal

Ventricularization

Damped

Note: Side holes allow perfusion, but dont prevent guiding catheter injury to the ostium

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

Active Soft Distal Segment Balanced Passive Firm Distal Segment

Requires precise curve selection and sizing

Active Support Balanced Support Passive Support No

Requires large Ostia Yes

Requires disease-free ostia

Yes

No
Yes

Indeterminate
Indeterminate

Indeterminate
Indeterminate

Four Families of Medtronic Guide Catheters

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

Medtronic Guide Catheters

Launcher:

Largest ID 6F (0.071) Full Wall Technology Consistent Lubricity Full Wall Technology Extra-Soft tip Choice of distal segment support in 6F

Sherpa NX:

Over 240 curves on every platform Custom curves made to order

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

Distal Segment Tip Secondary Curve
Sherpa NX Active French Size / ID 5: 0.058 6: 0.070 Sherpa NX Balanced 6: 0.070 7: 0.080 8: 0.088 Balanced: Flexible Supportive HDPE Yes, 3 mm proximal from tip Launcher 5: 0.058 6: 0.071 7: 0.081 8: 0.090 Flexible Supportive Coated / Silicone Yes, 3 mm proximal from tip Z2 5: 0.058 6: 0.070 7: 0.081 8: 0.091 Flexible Flexible Coated Yes, 3 mm proximal from tip

Primary Curve Secondary Curve Liner Marker Band

Active: Soft Supportive HDPE Yes, 3 mm proximal from tip