Day 1 (September 4, 2024)

7:30-8:30am

Registration and breakfast

8:30-8:45am

Welcome and ice breaker

8:45-9:00am

Bridging stent working group update

9:00-11:00am

Session 1: What do I really want in endovascular aortic-related devices: What are my wants and needs, and what is my tolerance for risk?

Session Objective: There are competing wants and needs for the various stakeholders involved with or affected by aortic-related devices and different tolerances for risks. The objectives of this session are to gain insights into the different perspectives that may provide a better understanding of boundaries around the development, evaluation and use of these devices.

Introduction

Topics: this section is purpose built – we all have the patient in mind but as we go through, we're further removed from the individual patient being treated

Patient perspectives (2)

Topics: What matters most as a patient with respect to initial outcomes, long-term follow-up, secondary interventions

• In the presence of an optimal outcome
• Burden associated with complicated outcome

Physician perspective

Topics: Expectations for device performance, definition of safe and effective treatment (initial and long-term), tolerance for secondary interventions

Hospital/Health System perspective

Topics: Driving factors for hospital economics, including device outcomes vs cost, re-intervention rates, reimbursement, economic value of life-long surveillance

Discussion

Manufacturer perspective

Topics: Desire to bring best devices to the patient within reasonable time/cost/margin, NPD project timelines, risk/benefit assessments, de-risking high-risk items (e.g., leveraging information from previous designs, PSIDE data, OUS data)

Financial perspective

Topics: Generating returns on investment, need to determine exit strategy, how investors look at investing/funding efforts, expectations behind ROI, examples of wins/losses and contributing factors (e.g., device performance, cost, regulatory)

FDA perspective

Topics: Protecting and promoting public health, FDA role in helping patients, SOA vs proposed new device impact, tolerance for risk

CMS perspective

Topics: CMS vs FDA regulations, impact of CMS decisions on device availability

Legal perspective

Topics: What matters in a court of law

Discussion

11:00-11:15 am    

11:15am-12:00pm

Session 2: Sustaining vs Innovation

Session Objectives: The objectives of this session are to understand the investment into sustaining engineering and the competition between meeting requirements for existing products and addressing wants and needs for innovation/improvements.

Introduction

Topics: Revisit what was presented last year and introduce other aspects: resource demands of keeping on market and clinical feedback

Regulatory requirements associated with changes

Topics: Submission types, data needs

Sustaining engineering to support an iterative update or supplier change

Topics: What is needed (e.g., non- clinical testing biocompatibility, clinical data), impact on current supply chain by taking/making new devices, cost of clinical studies, cost of various types of testing, consideration of return on investments, required vs desired changes, managing changes across global regulatory bodies

Sustaining engineering to support indication expansion (existing devices and new uses)

Topics: What is needed (e.g., non- clinical testing biocompatibility, clinical data), impact on current supply chain by taking/making new devices, cost of clinical studies, cost of various types of testing, consideration of return on investments, required vs desired changes, managing changes across global regulatory bodies  

Summary of the burden of sustaining engineering

Topics: What does it take to keep a device on the market & how do I stay competitive with the market? Where does the money go? Meeting regulatory requirements, conditions of approval, post approval studies; potentially walk through a recent sustaining/change project and discuss the time, resources, etc. it takes

Discussion

12:00-12:45pm

Lunch

12:45-1:30pm

Session 2 Continues: Sustaining vs Innovation

Unintended consequences of not making timely changes or not being able to develop technologies

Topics: How lack of timely innovation led to PMEG use in the past and the impact on current state of aortic treatment

Debate: We don’t always get what we want – long-term data vs new tools; what’s the priority for the money?

Topics:

• Need long-term data: Need adequate information to inform patients including the potential for needing secondary interventions after a manufacturer made EVG, vs risks associated with not having new technology (e.g., use of PMEGs)
• Need new tools: It’s better to provide tools with information/data limitations than to have longer term information on near obsolete technology. Are we more worried that there’s more PMEGs for which we have no data?

Marc Schermerhorn, MD (BI-Deaconess): New Tools

Mark Farber, MD (UNC): Need long-term data

Discussion

1:30-2:00pm

Session 3: Ask the Engineers/Manufacturers

Session Objective: The objective of this session is to engage with the people responsible for developing, testing, and manufacturing aortic-related devices to get a better understanding of the challenges they face in balancing wants and needs.

Introduction

Discussion

Engineers:
Janie Goldsworthy (Gore)
Jarin Kratzberg (Cook Medical)
Mithun Vora, R&D Director (Medtronic)
Yaxel Tablada (Terumo)
Dave Baker (Getinge)
Mary Dennehy (Shape Medical)

2:00-3:00pm

Session 4: Considerations around off-label use and on-label use

Session Objectives: The objectives of this session are to understand the meaning of on-label use and its practical implications and to investigate approaches for getting off-label on-label (i.e., a want of all stakeholders).

The session will provide insight on when and why off label use is performed by physicians. Additionally, understanding of the risk/benefit of off label use will be addressed and how physicians ultimately make the decision to move forward with off-label treatment. Finally, industry will provide insights into what is done in order to address off label use and the complexities of getting off label use on-label 

Introduction

What does on-label mean to FDA?

What does on-label mean to physicians/Physicians are going to do what is needed to treat a patient

Topics: Successful off-IFU treatment inclusive of PMEG and how included in standard of care

Bjoern Suckow, MD (Dartmouth Hitchcock)

Decision pathway for performing new, off-label procedures

Topics: Decision around first time off-label use (e.g., endo Bentall), transition between an idea and first use in a patient

How does industry deal with on-label vs off-label?  What is the burden on industry/physicians/patients with off-label use?

Internal training

Engineering due diligence

Discussion

3:00-3:15pm

Break

3:15-4:15pm

Session 4 Continues: Considerations around off-label use and on-label use

Getting off-label use on-label panel discussion

Moderator: Matthew Eagleton, MD (MGB)

Charlie Yongpravat (FDA/RWE)
FDA Rep - TBD

Simona Zannetti (Medtronic)
Scott Rush (Terumo)
Josh Lovekamp (Gore)
Jarni Kratzberg (Cook)

Ben Starnes, MD (U. Washington)
Shahab Toursavadkohi, MD
(U. Maryland)
Patrick Kelly, MD (Dakota Vascular)
Eric Roselli, MD (Cleveland Clinic)

Ethics around off-label use

Physician modified

Topics: Back table modifications

Industry – clinical support

Topics: There are potential fixes/improvements/modifications but are not done due to investment and time required.

Regulatory: pre-market vs post-market expectations

Discussion

4:15-5:30pm

Session 5: Small Group Discussion

Small Group Leaders: (2 clinicians, 1 FDA, 1 Manufacturer)

Group 1: Daniel Clair, Arminder Jassar
Group 2: Patrick Kelly, Chris Cheng
Group 3: Mark Farber, Nick Osborne 
Group 4: Marc Schermerhorn, Nick Swerdlow
Group 5: Adam Beck, Jahan Mohebali
Group 6: Andres Schanzer, Shahab Toursavadkohi
Group 7: Grace Wang, Frank Caputo
Group 8: Sherene Shalhub, Joseph Lombardi*
Group 9: Eric Roselli, Matthew Sweet
Group 10: Rob Rhee, Ourania Preventza
Group 11: Jeromy Brink, Bjoern Suckow

5:30pm

Day 1 Ends

6:30pm

District Winery – Reception and Dinner

Day 2 (September 5, 2024)

8:00-9:00am

Registration and breakfast

9:00-9:15am

Opening remarks

9:15-11:15am

Session 6: Accounting for diverse patient populations- introduction, expectations and impact

Session Objectives: The objectives of this session are to investigate the impact of the implementation of the FDA Diversity Action Plan Guidance on pre- and post-market studies of devices intended to treat aortic diseases and to discuss the relevance of diversity specific to aortic disease.

Introduction

Introduction by FDA on the Diversity Action Plan Guidance and what it means

Topics: Perceived benefits, need vs. want, how broad do we need to get (gender, ethnicity, age, socioeconomic factors; pre-market vs post-market expectations; Gore Conformable Excluder PAS example

Diversity in clinical studies for aortic devices; how are we currently doing?

Topics: Physician perspective on populations being treated; potentially discuss where they do see population differences that need additional attention;

discuss the potential need to set limitations on the numbers of diverse patients enrolled in a clinical study;

Target population vs. Study population  

Pre-market study; impact of diversity focus on trials

Topics: Think of a study such as TAAA – small patient population already, further reducing in “inclusivity” aspect, regulatory/testing/time to market focus)

Beth Tohill, PhD (Gore)

Robert Rhee, MD (Maimonides)

Post-market study: all comers welcome, a perfect place for diversity

Topics: Focus on how study could be designed such that many diversity questions could be assessed under one umbrella, findings could then inform IFU changes, expansion of indications, etc.

Anna Schumacher (Terumo)

Ben Starnes, MD
(U. Washington)

Importance of hospital infrastructure in supporting clinical studies

Discussion

Aortic disease itself is diverse

Topics: Standard aneurysm/dissection patient vs connective tissue disorders, discuss this in brief;

focus the talk on how we learn more about this patient group in terms of treatment/clinical outcomes (high risk group, smaller sample size, but potential for tremendous QoL impact)

Diversity in aortic tissue, results from the Matadors evaluation

Debate: Diversity matters in aortic disease

Topics/potential positions:

• Yes: There are different outcomes in the different patient populations (e.g., race); Are there different treatment or device design considerations by race
• No: This is a mechanical repair – diversity doesn’t matter – an aorta is an aorta

Ourania Preventza, MD (U. Virginia)*
vs

Discussion

11:15am

Break

11:30am-12:00pm

Session 7: Ask the FDA

Session Objective: The objective of this session is to engage with the people responsible for regulating aortic-related devices to get a better understanding of the challenges they face in balancing protecting and promoting public health.

12:00-1:00pm

Lunch

1:00-2:30pm

Session 8: Long-term follow-up

Session Objectives: The objectives of this session are to obtain stakeholder perspectives around the conduct of studies and registries and to discuss the benefits and limitations of data collection.

Understand trade-offs between sample size, data granularity, resource utilization, and data usefulness.  Participants (Industry and Regulators) should come away with new perspectives regarding the need to prioritize critical long-term follow-up objectives during study design, understanding that less may be more.  Physicians should gain appreciation for the commitment required for successful study participation and their value in long-term study execution.

Introduction

Compare and contrast pre-market, PAS, and VQI

Enrollment

Frank Caputo, MD (Cleveland Clinic)

Ami Sood, MD (Endologix)

Quality of data

Topics: Core lab vs site reported, monitoring

Nick Swerdlow, MD (MGB)

Data granularity/communication

Joe Lombardi, MD (Cooper U)*

Discussion

Case Study - VQI dissection project: 5-year lessons learned

VQI

Manufacturer

Clinician Perspective – publishing the information, and how could we achieve better results or is it fundamentally flawed?

Discussion

2:30-3:30

Session 9: Follow-up compliance

Session Objectives: The objectives of this session are to obtain stakeholder perspectives around the challenges of obtaining follow-up and to discuss follow-up compliance responsibilities and mechanisms for improvement.

Identify possible differences in compliance associated with subject demographics and implications to population diversity.

Introduction

What do you want and need as a physician

Topics: Mention the SVS recommendations for follow-up; Imaging requirements vs. Clinical Outcomes in Post Approval Studies: Would getting DUS alone make it more likely that someone would come back? Can we get 1, 3, and 5 year CTs with DUS in between? Utility of Remote follow-ups – is there useful data that can be gathered?  What is necessary to make the data from remote visits useful?

Current expectations and experiences with follow-up

VQI

Topics: What is follow-up in standard practice?  We have guidelines and how many people are actually meeting it without having a device clinical study?

Manufacturer

Topics: What control do manufacturers have?

CRO

Topics: Are there certain types of studies/approaches that yield better compliance?

Discussion

3:30-3:45pm

Break

3:45-4:15pm

Session 9 Continues: Follow-up compliance

Mechanisms for improving follow-up compliance: Michigan/Blue Cross example

Who is responsible for follow-up compliance and/or who should be?

Discussion

4:15-5:30pm

Session 10: Small Group Discussion

Session Objectives: The objectives of the small group discussions are to make progress toward a goal of a) collecting additional information around challenges with obtaining follow-up; and b) communicating a problem statement regarding follow-up compliance. After the small groups discuss, the groups will discuss together in effort to develop a consensus on moving toward the goal.

Small Group Leaders: (2 clinicians, 1 FDA, 1 Manufacturer)

Topics: What has worked, what hasn’t worked, what are the challenges
Group 1: Daniel Clair, Arminder Jassar             
Group 2: Patrick Kelly, Chris Cheng                               
Group 3: Mark Farber, Nick Osborne                   
Group 4: Marc Schermerhorn, Nick Swerdlow   
Group 5: Adam Beck, Jahan Mohebali                         
Group 6: Andres Schanzer, Shahab Toursavadkohi
Group 7: Grace Wang, Frank Caputo
Group 8: Sherene Shalhub, Joseph Lombardi
Group 9: Eric Roselli, Matthew Sweet
Group 10: Rob Rhee, Ourania Preventza
Group 11: Jeromy Brink, Bjoern Suckow

5:30pm

Day 2 Ends

6:30pm

Kick Axe Throwing Social and Dinner

Day 3  (September 6, 2024)

8:30-9:00am

Breakfast

9:00-11:00am

Wrap Up