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Update : November 14, 2008

	Left main coronary disease

	Ostial disease

	Bifurcation

	Graft vessel disease

	Diffuse coronary disease

	Chronic total occlusion (CTO)

	Restenosis

	Multivessel disease

	Drug eluting stent

	Vulnerable plaque

New Products List


	DRIVER Device Information : General Introduction

Device Information

General Introduction

Slide for Features & Benefits

Case Presentation

AMC Experience

/ User's Comment

Clinical Study

Driver
Rapid Exchange Coronary Stent System

Tine Struts Deliver Result

Benefits of Advanced Cobalt Alloy

The Driver stent is constructed from a cobalt alloy that has several benefits compared to 316L stainless steel. This alloy is stronger- it has a higher modulus, higher coefficient of strain hardening, and higher ultimate tensile strength, and it has a higher density. It is also more fatigue and corrosion-resistant and more MRI-compatible than stainless steel. Cobalt-based alloys have been used since 1937 in a number of medical implants, but never before in as coronary stent.

The Evolution Toward Thinner Struts

Medtronic AVE has been reducing strut dimensions with each generation of coronary stent. Thinner struts result in a more flexible, lower profile stent. Some research indicates that strut thickness may also play a role in restenosis. The market is moving towards thinner struts- thinner can then be achieved in a stainless steel design.

With the S7, the design of a modular stainless steel stent had been optimized. To further improve performance, Medtronic AVE has challenged the fundamentals of stent design starting with the metal. The new alloy delivers thinner struts without compromising radial strength or radiopacity. The Driver is both a premium performance uncoated stent and a future platform for our drug-eluting stent program.

Drive Optimizes Vessel Support

The Driver maintains the excellent scaffolding of the S7 with :

• Short, 1.0mm elements

• 10 crowns and 20 struts per element

• Small cell areas = high "resolution" coverage

• Maximum support resulting in clean angiographic appearance

• Custom fusion patterns which allow for side branch expansion

The increased strength strain hardening coefficient, and yield and modulus of the cobalt alloy were chosen to offset the reduction in strut thickness and maintain ideal radial strength properties.

New Warp - Crimp Process

One of the first things our S7 customers will notice about the Driver when handling it is that the profile has been significantly reduced. This difference is dramatic in as side-by-side comparison. It represents a reduction of about 0.006" (ed. From .048" to .043" for a 3.0mm Driver). This reduction in profile is achieved through a combination of two mechanisms :

1.	A new balloon wrapping process allows the balloons to be wrapped tighter to achieve a lower balloon profile.
2.	The thinner struts and a new crimping process allow the stent to be crimped tighter. You can see the result in this SEM where we have cut a cross-section of the catheter at the distal end of the crimped stent.

Lower profile contributes to greater flexibility and greater access to tight lesions for direct stenting.

Secure Technology - Designed for Direct Stenting

The Driver also continues the Medtronic AVE tradition of Secure Technology- a proprietary process using heat and pressure to partially encapsulate the stent struts with the balloon material. This process is used in addition to the stent crimping process to produce a smooth transition from balloon to stent, to protect the stent edges during advancement and withdrawal, and to enhance stent securement.

With the Driver, the design of the proximal pillow has been modified by reducing its length slightly. This design enhances its ability to protect the stent edges upon withdrawal.

You should feel very confident about the stent security of the Driver out of the box and in the body.

5F Compatibility - Designed for Direct Stenting

The 3.0, 3.5, and 4.0mm diameter Drive are all 5F (0.056" I.D.) guide catheter compatible. The 4.5mm Driver is 6F (0.064" I.D.) compatible. The low profile, excellent stent securement, and enhanced proximal pillow all contribute to confident use in 5F guides.

It is important to note here that the Driver IFU now allows for retraction of the stent delivery system back into the guide, if no resistance is felt.