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Storyboard and Writing SampleLesson: Medtronic’s Mosaic Stented Tissue Heart Valve

Template formatting, pictures and specific data tables have been deleted to minimize file size.

Content Outline

Overview Overview Objectives

Product Details Development History Features and Benefits• Indications for Use• Product Specifications

Performance Factors• Durability• Thromboresistance• Hemodynamics• Implantability

Clinical Studies• Market Need• Clinical Evidence• Our Competitive Advantage• Sales Scenario

Overview

The Mosaic bioprosthesis is Medtronic’s third-generation valve with outstanding durability. Its performance positions it to be a tissue valve of choice for most aortic and mitral tissue valve replacement surgeries, worldwide.

Objectives

At the end of this lesson, you will be able to:

Demonstrate product design and materials knowledge Associate performance enhancement with design factors Combine product design, materials, and performance factors to identify Mosaic’s

competitive edge Explain the significance of clinical study data

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Development History

In December 1983, Medtronic invested in Xenotech, the manufacturer of the Intact tissue valve, acquiring rights to market and sell its products; the Intact valve was not FDA approved, nor was it available for sale in the U.S. In 1987, Medtronic purchased Johnson & Johnson Cardiovascular, the makers of the Hancock II tissue valve.

Over the years, Medtronic’s tissue valve technologies evolved: (Note to production, create timeline of the text and pictures below)

First generation: High pressure fixation, no tissue treatments. Hancock, Hancock MOSecond generation: Low/zero pressure fixation, T6 tissue treatments. Intact, Hancock IIThird generation: Physiologic fixation, AOA tissue treatment. Mosaic, Freestyle

The first Mosaic bioprosthesis was implanted at Albertinen Krankenhaus hospital in Hamburg, Germany in February 1994.

Selling focus: Mosaic, a third generation valve, has over fifteen years of clinical data.

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Features and Benefits

Tissue Valve

When it comes to tissue valves, Medtronic’s focus, as always, is on quality. For every 100 pig hearts that enter the plant in Santa Ana, California, only five become Medtronic bioprosthetics.

ImageTitle: Figure 2, Mosaic Product FeaturesCaptionNotes to production: Make this a click and reveal using modal windows.

Source file name: Mosaic.jpg Mosaic 2.jpg

Modal Window text:1. Valve leaflets are made from a single porcine aortic valve, using physiologic pressure

fixation. It preserves leaflet collagen so that the circumferential (required for initial opening) and radial (for complete opening) stretching of the fibers are maintained. Porcine leaflet tissue allows excellent coaptation because the cusp tissue stretches far more in the radial direction than in the circumferential. In addition, the nodes of Aranti at the tips of the leaflets form a seal that helps to avoid regurgitation.

2. Mosaic is Medtronic’s third generation stented tissue valve. As such, it is not only sterilized, preserved, and stabilized through its gluteraldehyde fixation and storage medium, but it is also chemically treated with the AOA antimineralization treatment to address biochemical failure.

3. Physiologic pressure fixation addresses biomechanical failure and preserves anatomy through exerting 0 mm Hg across the leaflets. This allows the leaflets to float freely, thus preserving leaflet structure; it is also the reason the leaflets remain open during shipping and storage.

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4. The acetal homopolymer stent reduces stress on the tissue when the valve closes while maintaining controlled flexibility after implanted within the heart.

5. It has asymmetrical commissure support that conforms to the natural anatomy of the fixed porcine aortic valve.

6. It has a polyester stent cover and suture ring, which encourages tissue ingrowth. Mosaic Aortic has a scalloped sewing cuff to conform to the patient’s native anatomy.

7. It has metal stent post markers, which allow radiographic visualization of stent post tips after implantation.

For the Mosaic valve, standard valve sizers (obdurators) are green.

Quick Check – Multiple Select

Instructions: Choose all that apply, then select Submit.

In what way(s) do(es) the acetal homopolymer stent give the Mosaic valve an edge over the competition?

It flexes without compromising the stent material.

It reduces stress on the tissue when it closes.

It conforms to the natural anatomy of the annulus.

It allows for optimum coaptation with a complete seal.

Feedback Text:

Correct Feedback: The acetal homopolymer stent gives Mosaic an edge over the competition because it flexes without compromising stent material and reduces stress on the tissue at the same time.

Incorrect Feedback. 1st Attempt: Try Again

Incorrect Feedback. 2nd Attempt: Because the acetal homopolymer stent flexes without compromising stent materials and reduces stress on the tissue when the leaflets close, this provides an edge for Mosaic over the competition.

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Durability

The Mosaic stented tissue valve has fifteen years of data demonstrating its clinical safety and excellent performance with the highest durability compared to similar valves.(specific data deleted)

What is the secret to Mosaic’s longevity? Flexible stent The amino oleic acid (AOA) antimineralization treatment to help mitigate calcification Physiologic fixation that preserves leaflet structure, ensuring that leaflets function similarly

to native aortic valves

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Hemodynamics

Because tissue valves open physiologically as native valves do, they provide excellent forward flow and do not allow the same kind of retrograde flow, jetting, and regurgitation that mechanical valves exhibit.

Surgeons must always size the valve to the patient’s appropriate body surface area (BSA).

Mosaic Aortic Ultra’s reduced sewing cuff provides surgeons with the flexibility to implant a larger sized valve, which could potentially improve blood flow and EOA. In addition, its scalloped sewing ring follows the aortic annulus, allowing complete supra-annular placement.

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Thromboresistance

Generally, due to their design and materials, tissue valves do not put the patient at constant risk of thrombogenesis as mechanical valves do.

Remember, however, that AHA guidelines recommend placing tissue valve recipients on anticoagulation therapy for three months after receiving the bioprosthesis.

Surgeons use tissue valves to avoid lifelong anticoagulation therapy for their patients.

Quick Check – Multiple Select – please randomize

Instructions: Choose all that apply, then select Submit.

What kind of blood flow do tissue valves avoid that mechanical valves do not?

Jetting

Regurgitation

Retrograde flow

Forward flow

Feedback Text:

Correct Feedback: Tissue valves avoid jetting, regurgitation, and retrograde flow, which, due to their design, mechanical valves do not. Tissue valves allows excellent forward flow.

Incorrect Feedback. 1st Attempt: Try Again

Incorrect Feedback. 2nd Attempt: Due to their design, mechanical valves allow retrograde flow, jetting, and regurgitation, where tissue valves allow excellent forward flow.

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Implantability

Cinch® Implant System facilitates aortic valve insertion, particularly through a tight sinotubular space. It is especially suited for minimally invasive procedures.

Cinch Implant SystemThe Cinch Implant System comprises a disposable blue plastic holder attached to the valve with highly visible contrast sutures. Designed to protect tissue from inadvertent damage, it is shipped in the jar with the valve and used with a recyclable and re-sterilizable handle similar to those used with annuloplasty rings.

The Cinch Implant System highlights the flexibility of the valve, making it easier to implant.

ImageTitle: Figure 3, Cinch Implant SystemCaption: Aortic Valve and as marked (Mitral Valve) and add labels

Source file name: Cinch Implant System.jpg Cinch MitralGreen suture.jpg (remove A from lowest image)

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The laser-engraved and embossed size marker on the holder is oriented to denote the largest native valve leaflet.

Highly visible contrast sutures

Low profile holder and ratcheting mechanism draws the stent posts in. Aortic valve - provides better

visualization and more room for tying behind the stent posts

Mitral valve - helps prevent looping of the sutures around the stent posts

Color easily differentiates Cinch from the stent posts

Mitral Valve

The green suture marker on the sewing ring of the mitral valve is positioned toward the right fibrous trigone.

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When implanting a Mosaic valve, several items must be kept in mind: After the Cinch holder is screwed onto the handle, the mechanism is activated by further

rotation, causing the stent posts to be drawn inward simultaneously. For ease of suturing, the holder does not hinder or obscure access to the sewing ring. The holder does not have to be removed to complete suturing, so the stent posts remain deflected throughout the implantation procedure until the sutures are cut and holder removed.

When orienting a Mosaic aortic valve, the surgeon must take care not to block the coronary ostia.

The mitral Cinch should be ratcheted until the three stent posts are 1 mm apart from each other.

The aortic Cinch holder is fully activated when the tension is so great it becomes difficult to ratchet.

The Cinch device should not be activated for over 30 minutes.

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The part of the mitral Mosaic that sits in the ventricle includes the stent posts.

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Quick Check – Multiple Choice

Instructions: Choose the correct answer, then select Submit.

How does the Cinch II Implant system aid implantability?

It holds the stent posts in place until the sutures are removed.

It allows the surgeon to visualize the coronary ostia less easily.

The sutures are transparent for ease of removal and deployment.

Its green suture marker on the sewing ring is positioned toward the left fibrous trigone.

Feedback Text:

Correct Feedback: One of the ways the Cinch II Implant System aids implantability is by holding the stent posts in place until the sutures are removed.

Incorrect Feedback. 1st Attempt: Try again.

Incorrect Feedback. 2nd Attempt: One way that the Cinch II Implant System aids in implantability is by maintaining stent post position until the sutures are removed.

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Selling Scenario:

Instructions: This scenario presents a real-world situation that allows you to self-assess your product knowledge and practice your selling skills.

Notes to Production:Insert a Storyline Learning Object here. ImageTitle: Dr. ThurstonSource file name: iStock http://www.istockphoto.com/stock-photo-11224631-speciality-doctor.php?st=4a7305d

Question 1

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A“First generation valves are yesterday’s technology. And based on our findings in durability, chances are good that your patients could live longer.”

At a local hospital, you meet a seasoned cardiothoracic surgeon, Dr. Thurston. He was unimpressed with first generation porcine valves and has never given them a second thought since.

He asks, “What difference would it make to my patients if I changed to porcine valves now?”

B (correct answer)“Agreed, first generation valves needed work. We kept refining and improving to today’s third generation valve that has great durability and hemodynamics.”

C“Agreed, first generation valves needed work. But today’s data is just awesome; wait until you see our 15-year data on the Mosaic.”

Potential Answers

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ImageTitle: Dr. Thurston’s Second Question

Source file name: iStock http://www.istockphoto.com/stock-photo-11485343-team-doctors.php?st=d211ae0

Question 2

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After his resident joins the discussion, the surgeon asks, “But what about pressure gradients? I thought I’d heard that Medtronic’s bioprosthetics had high pressure gradients.”

A“Medtronic’s pressure gradients are actually lower than our competitors will admit to.”

B (correct answer)“The difference is just a couple of points. Is that clinical significant?”

C“Pressure gradient is a non-issue at this point because it’s unprovable.”

Potential Answers

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Image Source file name: iStock http://www.istockphoto.com/stock-photo-11256788-friendly-team-doctors.php?st=489b6f7

Question 3

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The surgeon says, “I understand how important durability is, so why would I ever put a tissue valve into someone under 60?”

A“Mosaic’s 15-year data shows that it is as durable as any mechanical valve in patients of all ages and especially inpatients under 60.”

B (correct answer)“Mosaic’s 15 year data suggests that this tissue valve may be an option for a younger patient due to its durability.”

C“Mosaic’s 15-year data shows clearly that that it does not fail in patients under 60.”

Potential Answers

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Resources

Mosaic IFU

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