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Insights from the Melody Pulmonic Transcatheter Valve Panel

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Presentation on theme: "Insights from the Melody Pulmonic Transcatheter Valve Panel"— Presentation transcript:

1 Insights from the Melody Pulmonic Transcatheter Valve Panel

2 Disclosure Slide Thomas Armitage is an employee of Medtronic, Inc.
I just had knee surgery (hence the crutches, knee brace and blue jeans)

3 Melody Overview Melody Transcatheter Pulmonary Valve (TPV)
Melody Valve: Bovine jugular venous valve segment Platinum-iridium stent Ensemble Catheter Delivery System 22 Fr crossing profile Balloon-in-balloon

4 FDA Advisory Panels

5 What is an FDA Advisory Panel?
FDA Advisory Panels Committees of experts to provide an independent assessment Make recommendations Circulatory System Devices Advisory Panel Physicians and scientists Consumer and industry representative Executive Secretary (FDA employee)

6 What is an FDA Advisory Panel?
Panel meetings sometimes referred to as “running the gauntlet” . . .a form of punishment in which the culprit was made to run stripped to the waist between two rows of men who whipped and beat him as he passed by. These beatings were extremely severe and the victims often died as a result - and many of those that didn't may well have wished they had. Yeah, that sounds right

7 Panel Prep Timeline Elapsed Prep Time: 2 Months

8 Key Considerations for Melody Panel
Primary Considerations Alignment with FDA Presentation and Presenters The Risk / Benefit Equation Secondary Consideration The open public session Media Interest

9 Key Considerations for Panel
Alignment with FDA Reach agreement with the FDA, or at least agree to disagree, before the Panel Don’t force a Panel meeting unless necessary. This is a tactic of desperation. The FDA’s concerns re your technology are reflected by their questions to the Panel members Make it a point to address the FDA’s questions in your presentation

10 Key Considerations for Panel
Presentation Anticipate Being surprised or confused at a Panel meeting can change votes. Anticipate all questions. Be prepared with any materials to answer any question Prepare Mock Panels are valuable. Hire uninvolved experts to critique your presentation

11 Key Considerations for Panel
Presentation Melody Backup Preparation: Backup Slides: 554 (1.8 GB) Anticipated Questions: 199 Questions asked by Panel: 30 Questions requiring new slides: 2

12 Melody Panel Presenters
Takeaway Messages Panel meetings are almost always about the clinical data: Let the clinicians do the talking Select the right clinicians Respected, calm, not easily provoked De-emphasize the sponsors role in the discussion Let the sponsors presenter(s) play quarterback

13 Melody Panel Presenters
Tom Armitage, MD John Cheatham, MD William Hellenbrand, MD James Lock, MD 10 Clinicians / 1 Medtronic Person Additional Experts: Prof Philipp Bonhoeffer, MD Robert Padera, MD, PhD Patrick O’Leary, MD Anjan Batra, MD Marshall Jacobs, MD John Mayer, MD Joseph Massaro, PhD

14 The Risk / Benefit Equation
Risk / Benefit Background FDA Draft Guidance on Risk / Benefit

15 The Risk / Benefit Equation
Risk / Benefit Background FDA Draft Guidance on Risk / Benefit A reasonable assurance of safety occurs when “it can be determined, based upon valid scientific evidence, that the probable benefits … outweigh any probable risks.” The evidence of which is demonstrated by establishing, “the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use.” (21 CFR 860.7(d)(1). Similarly, a reasonable assurance of effectiveness occurs when “it can be determined, based upon valid scientific evidence … the use of the device for its intended uses … will provide clinically significant results.” (21 CFR 860.7(e)(1)). The evidence of which is demonstrated principally through “well-controlled investigations” (see 21 CFR 860.7(e)(2)) as defined in 21 CFR 860.7(f)

16 The Risk / Benefit Equation
Opportunities with the Melody Program In the absence of an RCT, the risk/benefit analysis may need to be made using two different technologies with different risks: Melody Risk of reintervention vs Surgical Conduit Replacement Risk of the Surgery Risk of Right Heart Failure 2○ to delayed surgical intervention

17

18 Melody FDA Panel Recommendation for Approval
Panel unanimously recommends approval with conditions (12-0)

19 Thank You


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