7:45-8:30am

Registration and breakfast

8:30-8:45am

Welcome and ice breaker

Matthew Eagleton, MD (MGB)

8:45-10:30am

Session 1: Introduction and Part of Steps 0-4

Milestones to cover:

• Step 0 | Market Validation and Ideation (Payment covered in Session 4):
• Market opportunity report
• Step 1 | Prototyping
• Step 2 | Building the Business Case:
• Feasibility report
• Market Spec – product description from the physician’s/user’s perspective
• Step 3 | Engineering Development:
• Solidify the design – Product Spec – product description in precise engineering terms
• Obtain scoping/screening bench data appropriate given the risk to the patients (i.e., patient risk-driven)
• Create test sample demand plan
• Complete design control documents (e.g., design trace matrix, design verification master plan, DFMEA, PFMEA, use design risk analysis)
• Design freeze (business milestone)
• Step 4 | Design Verification Testing (Non-GLP Animal Study, if applicable, covered in Session 3)
• Obtain data needed to show device meets product specifications
• Obtain scoping/screening biocompatibility data appropriate given the risk to the patients
• DV report

8:45-9:00am

Introduction

Robert Whirley, PhD
(Engineer Supreme)

9:00-9:15am

Steps 0-2 (ideation)

Design input identification in the real world

Jarin Kratzberg, PhD
(Cook)

That would be great to have – is it worth doing the work?

Josh Lovekamp, PhD
(Gore)

9:15-10:05am

Steps 3-4 (design development and verification)

Introduction: including compare and contrasting

Ben Wolf
(Abel and Wolf)

Deep dive: notebook studies

TBD

Making choices – finalizing the design and specs based on what’s possible and the market opportunity. When is enough...   enough?

Deepal Stevenson
(Artivion)

Negotiating and navigating change with stakeholders (e.g., clinicians, regulators) – Tension between what clinicians want and what the FDA allows and budge/time

Robert Whirley, PhD
(Engineer Supreme)

Deep dive: design verification and pre-clinical validation testing

*Melissa Renteria
(Medtronic)

The clinical cost of delays to product availability

Shahab Toursavadkohi, MD
(University of Maryland Medical Center & School of Medicine)

Animal Study Considerations for Complex Aortic Repair

*Karen Manhart  
(FDA)

10:05-10:30am

Discussion

10:30-10:45am

Break

10:45-11:50am

Session 2: Part of Step 5/6

Milestones to cover:

• Steps 5/6 | Clinical (GLP Animal Study covered in Session 1):
• Prove it works for yourself
• Prove it to others

10:45-11:30am

Steps 5/6 (clinical)

Moderator:
*Carmen Gacchina-Johnson, PhD (FDA)

Clinical overview: Little bit of what gets done in these phases and how it gets allocated, timelines associated w/IRB approvals, CMS submissions, contracts,… Typical costs and cost drivers of each type study. Perspectives of startup (time &. burn rate) vs. strategic (multiple commercial product lines; NPD is not the focus of the entire organization).

• Feasibility – Internally confirm that we know it works and address rules around FIH/EFS
• Pivotal Study - Prove to everyone else that it works
• Post Market Study

Don Tunucci
(Gore)

Considerations with regard to totality of clinical data to support marketing of complex aortic repair device

*Gordon Bryson
(FDA)

Mitigating liability risk in clinical studies: OUS FIH, US EFS, US Pivotal

*Sean Burke
(Duane Morris, LLP)

Clinical feasibility strategies: What works when? US based EFS vs. OUS based FIH? PSIDE vs. Internal/Company EFS?

Sara Sherman
(Cook)

Clinical perspective talk (OUS experience, then US pivotal)

Grace Wang, MD
(Penn Medicine)

Clinical costs

• Compare types of studies
• Per patient, per site, per geography
• Follow-up as a cost driver: assessment modality/imaging, f/u duration
• Not being able to use feasibility toward pivotal
• Performance goals and predicates

Jeff Mifek
(Terumo)

11:30-11:50am

Discussion

12:00-1:30pm

Networking Lunch – with an Ask the FDA Session

Ask the FDA:
*Carmen Gacchina Johnson, PhD, *Aurko Shaw, and *MaiQuyen Nguyen

1:30-2:35pm

Session 3: Steps 7, Part of 9, 10, and Part of 11

Milestones to cover:

• Step 7 | Complete Activities Necessary for Regulatory Milestones for the IDE:
• Submit IDE
• Step 9 | Complete Activities Necessary for Regulatory Milestones for the PMA
• Step 10 | Begin PMA Process:
• Get PMA approval so can sell (more broadly) for a higher price
• Step 11 | Complete/Address Post-market Conditions (Secure Reimbursement covered in Session 4)

1:30-2:05pm

Steps 7, 9, 10, and 11 (activities for regulatory milestones)

Overview (including regulatory): How do we get through the IDE & PMA

Scott Rush
(Terumo)

Deep Dive: Durability Considerations in the Visceral Segment

Nonclinical testing considerations for complex aortic repair.

*Nicole Shiavone
(FDA)

Durability Basics

• Axial loading & Respiratory loading – fenestrations vs. branches
• Take-off angulation and gap distance - aortic device from wall
• Balloon vs. Self-Expanding

Chris Cheng, PhD
(Stanford University)

Does the existence of bridging stent in a branch/fenestrated device affect the loads on proximal stent (as compared to a more standard infrarenal repair)?

Rob Friederichs
(Gore)

Clinical – Back in clinical practice - where are the clinical concerns – if any.  Are there preferences for selection of stents for a given visceral vessel?

Darren Schneider, MD
(Penn Medicine)

2:05-2:35pm

Discussion

2:35-2:50pm

Break

2:50-4:05pm

Small Group 1: How device designs are selected vs how they should be selected

Moderators:
Jarin Kratzberg, PhD (Cook) and Physician (TBD)

Small Group Leaders:
Group 1: Shahb Toursavadkohi & Mark Farber
Group 2: Rob Rhee & *Carlos Timaran
Group 3: Matt Sweet & Omar Selim
Group 4: Ben Starnes & Grace Wang
Group 5: Sunita Srivastava & Bjoern Suckow
Group 6: V. Patel & Darren Schneider
Group 7: Dan Clair & Jassar Mohebali
Group 8: Randy Moore & Nick Swerdlow
Group 9: Marc Schermerhorn & Sukgu Han

4:05-5:15pm

Session 4: Steps 0, 8, and Part of 11, and Part of Steps 2 and 5-6

Milestones:

• Step 0 | Payment Opportunities:
• Part of market opportunity report
• Step 8 | Initiate Reimbursement Planning
• Step 11 | Secure Reimbursement
• Step 2 | Building the Business Case:
• Close pre-seed or seed investment (e.g., angels, family offices, grants)
• Step 5/6 | Clinical and GLP Animal:
• Support next round of investment (i.e., first institutional round – Venture Capitalists (investors) or strategics (grow product portfolio or learn the space))

Session Objective(s):

4:05-4:20pm

Steps 0, 8 and 11 (reimbursement)

Moderator:
Sara Sherman
(Cook)

Pre-market
Reimbursement: How does the device get paid for?
Pre-market considerations for reimbursement that factor into the business case. What if this device is different that it doesn’t match anything currently available and needs its own code?

Adam Borden
(Gore)

Post-Market
Clinical perspective – cost of complex repair.  How much does cost affect clinical decisions?  Do surgeons know what various items cost at their hospital? How is cost discussed with patients?

Sunita Srivastava, MD
(MGB)

4:20-4:30pm

Steps 2 and 5/6 (VC and strategics)

VC Funding
NOTES: What is an attractive VC investment?  How do they arrive at a valuation? What do they look for? Market, team, maturity of the technology, customer obstacles to adoption, clear regulatory path? What exit value is needed to be a viable investment for a particular device?
option

*Zack Scott
(Northwest Venture Partners)

4:30-4:40pm

Q&A

4:40-4:55pm

The Cost of Doing Business Summary 

• Pie chart
• Where does the money go?
• Complaint handling
• Pre / Post market studies (ratio between 2)
• R&D Development
• Burn rates
• Excluding sales/marketing/commercial costs

Nectero perspective
Vs.
Medtronic

4:55-5:15pm

Discussion

5:15-5:45pm

Day 1 Wrap Up

6:30pm

Faculty Networking Dinner and Report Out (Location TBD)

7:45-8:45am

Registration and breakfast

8:45-9:00am

Update on Bridging Stent
 

Dorothy Abel
(Abel and Wolf)

9:00-10:15am

Small Group 2: Development and adoption of complex aortic repairs
Moderators:
Scott Rush (Terumo) and (TBD)

Opening: perpetual unmet clinical needs – will we always need PMEGs?

Ben Starnes, MD
(University of Washington)

Small Group discussion

Small Group Leaders:
Group 1: Shahb Toursavadkohi & Mark Farber
Group 2: Rob Rhee & *Carlos Timaran
Group 3: Matt Sweet & Omar Selim
Group 4: Ben Starnes & Grace Wang
Group 5: Sunita Srivastava & Bjoern Suckow
Group 6: V. Patel & Darren Schneider
Group 7: Dan Clair & Jassar Mohebali
Group 8: Randy Moore & Nick Swerdlow
Group 9: Marc Schermerhorn & Sukgu Han

10:15-10:30am

Break

10:30am-12:00pm

Session 5: Look Toward the Future and Preventative Medicine

Moderator:
Matthew Eagleton
(MGB)

10:30-10:40am

Introduction

Matthew Eagleton, MD
(MGB)

10:40-11:10am

Prevention of aneurysm growth – Treatment of small/mid-sized aneurysm options

Physician perspective - What will preventing growth mean to the vascular surgeon

V. Patel, MD
(Columbia Aortic Center)

The Boneyard – what hasn’t worked 
NOTES: Small aneurysm EVAR, doxycycline, etc.

Ken Ouriel, MD
(21 Bridge Capital Partners)

The Crystal Ball – What’s coming next? (e.g., Nectero, Angiolutions)

Dan Clair, MD
(Vanderbilt University)

11:10-11:25am

Q&A/Discussion

11:25-11:50am

Improving patient selection & management/follow-up

What will improving patient selection mean to the vascular surgeon

Randy Moore, MD
(University of Calgary)

Why are we treating who we treat today?  (basis of current risk stratification criteria)

Jim Black, MD
(Johns Hopkins Medicine)

What’s coming next? (e.g., VITAA, Aneurisk)

David Vorp, MD
(University of Pittsburgh)

11:50am-12:15pm

Q&A/Discussion

12:00-1:00pm

Lunch

1:00-1:30pm

Debate:
Failure to Regress: An indicator of all cause mortality? What is the goal?

Moderator:
Matthew Eagleton, MD (MGB)

Regression is needed and beneficial for all-cause mortality

Marc Schermerhorn, MD
(Beth Israel Deaconess Lahey)

Data is hog-wash – failure to regress doesn’t have any impact on all-cause mortality

Frank Arko, MD
(Atrium Health)

Rebuttals

1:30-1:45pm

Discussion

Prevention of future complications (e.g., migration, Type II, failure to regress)

1:45-2:15pm

Neck Management

What is the unmet clinical need? Is there one?
NOTES: Will need to cover both sides of the argument – needed and not needed.

Mark Farber, MD
(University of North Carolina)

What’s coming next? (e.g., Exovasc, Endoron, increased adoption of Heli-FX) – One slide per company

Jahan Mohebali, MD
(MGB)

Q&A/Discussion

2:15-2:45pm

Sac Management

What is the unmet clinical need? Is there one? (coils, plugs)
NOTES: Will need to cover both sides of the argument – needed and not needed.

Rob Rhee, MD
(Maimonides Medical Center)

What’s coming next? (e.g., Shape Memory, LifeSeal, TripleMed)

Nick Swerdlow, MD
(MGB)

Q&A/Discussion

2:45-3:00pm

Break

3:00-3:45pm

Secondary/additional interventions
NOTES: Clinical need to allow for future procedures

Need to preserve future intervention options

*Carlos Timaran, MD
(UT Southwestern Medical Center) &
TBD (Cook)

Less complex secondary interventions should be the goal

Sara Zettervall, MD
(University of Washington) &
TBD (Terumo)

Complex repair is the next step after failing EVAR

Sukgu Han, MD
(University of Southern California) &
Kimberley Wunder, PhD
(Gore)

There won’t be secondary interventions after neck and sac management

Bjoern Suckow, MD
(Dartmouth Hitchcock) &
*Dipan Ghosh
(Medtronic)

Q&A/Discussion Look to add additional discussion time.

3:45-4:00pm

Session 5 Discussion
NOTES: What do you think is most important and why?

4:00-5:15pm

Small Group 3: What do you need to consider when deciding
which treatment to select for a patient?

Moderators: Matthew Sweet, MD (UW Medical Center – Montlake) and
Matthew Eagleton, MD (MGB)

Small Group Leaders: (2 clinicians, 1 FDA, 1 Manufacturer)
Group 1: Shahb Toursavadkohi & Mark Farber
Group 2: Rob Rhee & *Carlos Timaran
Group 3: Matt Sweet
Group 4: Ben Starnes & Grace Wang
Group 5: Sunita Srivastava & Bjoern Suckow
Group 6: V. Patel & Darren Schneider
Group 7: Dan Clair & Jassar Mohebali
Group 8: Randy Moore & Nick Swerdlow
Group 9: Marc Schermerhorn & Sukgu Han

5:15-5:45pm

Day 2 Wrap Up

6:30pm

Faculty Networking Dinner and Report Out (Location TBD)

Breakfast

9:00-11:00am

Review of Key Issues
Agenda for Stent Summit 2026