Leaders gonna lead
Who is the Senior Vice President of Structural Heart, reporting up through Medical Devices
Sandra Lesenfaants
Which studies do the Therapy Development Specialist Team currently support?
Envision, Repair MR, Catalyst, and Veritas
What TMVr Studies are currently enrolling or in development?
Repair MR and Coapt II
Name the Catalyst CSL and TDS Champ
Romina and Hannah
How many patients have been enrolled in Envision in 2025?
91
246 total
This person is the Divisional Vice President for Structural Heart Global Clinical Affairs
Barathi Sethuraman
Name the 4 Therapy Development Managers and Regions
West - Brooke Cummings, Central - Danelle Homeyer, Great North - Kris Vance, SE - Hannah Adams
Enrolling SI Studies
Veritas, Catalyst, Paradigm
Name the Repair MR CSL and TDS Champ
Kevin Parikh and Brooke Cummings
What happens to a patient who is consented but not randomized in Catalyst if 2400 analysis is positive?
Consented but not randomize = withdrawn
Randomized - proceed with treatment in randomized arm
Which 5 Directors Report to the DVP for SH?
Ryan Palmer (Cardiac Surgery + SI), Meghan Griffin (Tricuspid Repair/Replacement), OPEN (TAVI), Kyle Brunner (Transcatheter Mitral Repair/Replacement), Stephen Imig (Therapy Development)
How many Therapy Development Specialist are currently in place?
10
Enolling or coming soon TAVI Studies
Envision, Stellatus, Vantage (Europe)
Name the Envision CSL and TDS Champ
Jacob Simon and Danelle Homeyer
What is the minimum number of commercial cases required for an implanter to be approved to enroll in the ViV registry?
No minimum as ViV is currently off label.
Who (job function) reports into each Director?
Clinical Science, Field Clinical Procedural Specialist.
or
Therapy Development Managers
Commercial SH Leadership Two Divisional VPs and Roles
Omari Bouknight - Stroke Intervention (Stroke Prevention and Congenital Heart Disease)
Jason Gentiles - Heart Valves (TAVI, TMTI, Surgical Valves)
Enrolling or coming soon TMVI studies
Summit and Cephea
Catalyst Commercial Champion
Erin Baier
Enrollment goal for Repair MR is 500 subjects. To complete enrollment what all needs to occur?
500 randomizations
GCO/Regulatory Affairs Vice President Reporting to Executive VP Medical Devices
Gary Johnson/Priya Jagasia
Jeff Dressler report to Gary
If you are Stephen Imig, how many patterns do you have to wear at once to make it stylish?
Minimum of 3
Name the 6 Therapy/Franchises within Structural Heart.
Transcatheter Mitral Valve Replacement, Tricuspid Therapies, Transcatheter Mitral Valve Repair, Transcatheter Aortic Valve Replacement, Structural Interventions, Surgical Valves
Who is the PM for Catalyst
Paolo Amato - Katherine Tollefson supporting partially, transitioning to Cephea
Which site in the SE is the highest enroller in TDS supported studies?
Vanderbilt - 59
Catalyst - 53, Repair - 4, Envision - 2