Update on a Tethered Transapical Device for TMVR Vinay Badhwar, MD

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1 Update on a Tethered Transapical Device for TMVR Vinay Badhwar, MD Gordon F. Murray Professor and Chairman Department of Cardiovascular & Thoracic Surgery WVU Heart and Vascular Institute West Virginia University Morgantown, WV

2 Disclosures No Relevant Financial Disclosures Co-Chair Tendyne Global Steering Committee, operated by Abbott (uncompensated)

3 Transcatheter MVR Landscape Company Product MR Target Approach Regulatory Status Abbott Vascular Tendyne Primary/Secondary TA FIH CE Trial, US EFS Neovasc Tiara Primary/Secondary TA FIH CE Trial, US EFS Edwards Lifesciences CardiaQ Primary/Secondary TA, TS FIH CE Trial, US EFS Medtronic Twelve Secondary TA FIH OUS/US EFS Edwards Lifesciences Fortis Secondary TA FIH OUS EFS halted MValve Technologies Boston Scientific MValve Primary/Secondary TA FIH OUS EFS Cephea/Abbott Cephea Secondary TF Pre-Clinical In Development HeartWare/Valtech Cardiovalve Secondary TF Pre-Clinical In Development MitrAssist MitrAssist Primary/Secondary TA Pre-Clinical In Development HighLife HighLife MVR Secondary TA, TF Pre-Clinical In Development Emory University MitraCath Secondary TA Pre-Clinical In Development Micro Interventional EndoValve Secondary TF Pre-Clinical In Development NCSI, Inc. Navigate TMVR Secondary TA, TF Pre-Clinical In Development One Valve OneValve Primary/Secondary TS Pre-Clinical In Development J Thorac Cardiovasc Surg 2016;152:330-6

4 Tendyne Transapical, retrievable repositionable trileaflet porcine valve with an impermeable nitinol skirt Variable D-shaped self expanding outer frame, constant circular inner core Atrial component has large mm cuff Apical tether anchoring mechanism with secure locking pad

5 Tendyne Inclusion Criteria Severe MR of primary or secondary etiology NYHA class II, III or ambulatory IV Age >18yrs, able to provide informed consent Not suitable candidate for cardiac surgery as determined by the Heart team (including Cardiologist, Imager and Cardiac Surgeon)

6 Tendyne Exclusion Criteria Severe mitral annular or valvular calcification/stenosis, vegetation or mass Largest annular dimension <45mm LVEDD >70mm, LVEF<30% severe TR/RV dysfunction/pulmonary HTN Prior aortic or mitral valve surgery Small neo-lvot (echo, CT model, 3D printing)

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10 Image courtesy of D. Muller, St Vincent s Hospital

11 Tendyne LP Valve Design Tendyne LP 2.0 valve Tendyne 1.0 valve Smaller sealing body height Smaller inner frame diameter

12 Tendyne Low Profile 2.0 Valve Introduced into CE Mark Study in mid-2016 and US EFS late-2016 Estimated to reduce screen failure for LVOTO by ~50% Tendyne LP valve (blue) Tendyne 1.0 valve (yellow) Tilted (biased) trajectory Orthogonal trajectory

13 Tendyne Early Results Global Feasibility Trial (n=30) JACC 2017;69:

14 Global Tendyne Experience Abbott NW West Virginia University EFS/CE Mark Study Site Name (n=18 sites) St. Vincent s Prince Charles Hospital Baylor Delray Medical Center Northshore Emory Henry Ford Hospital Pinnacle Health Cleveland Clinic MedStar Honor Health Oslo University Hospital San Donato Royal Brompton Flinders San Raffaele Total experience > 100 cases Longest follow-up 2.9 yrs US Pivotal Commencing 2018

15 Tendyne GFS (n=75) Age at Baseline Mean+SD years Range years Gender Male 50/75 (67%) Female 25/75 (33%) NYHA Functional Class II 26/74 (35%) III 45/74 (61%) IV 3/74 (4%) STS Score (range) (2-16 ) STS>8 27/75 (36%)

16 Tendyne GFS (n=75) Characteristics Primary (n=20) Secondary (n=55) Age Female gender 9/20 (45%) 16/55 (29%) NYHA III/IV 15/20 (75%) 33/54 (61%) STS PROM >8 7/20 (35%) 20/55 (36%) LVEF 52% 47% Pulmonary HT 58% 38% Atrial fibrillation 75% 60%

17 Tendyne GFS: 30-day Outcomes Protocol Defined Device Success at 30 Days Success 80% (60/75) Any Failure* 20% (15/75) Mortality 6.7% (5/75) Implant not Successful 4.0% (3/75) LVOT Obstruction 1.3% (1/75) Valve did not seat properly 1.3% (1/75) Patient became hemodynamically unstable, procedure 1.3% (1/75) not completed, unplanned circulatory support Any re-intervention 2.6% (2/75) Reposition Device- resolve PVL 1.3% (1/75) Bleeding with re-operation 1.3% (1/75) Device-related performance or Adverse Events* 5.3% (6/75) Mitral valve gradient > 6 mmhg 5.3% (4/75) Paravalvular Leak 1.3% (1/75) Device Malpositioning 1.3% (1/75) Device Thrombosis 1.3% (1/75) *Note: Multiple events in single patients - patient totals are not equal to individual event totals (rows do not sum as expected)

18 Tendyne Summary Fully retrievable, repositionable device Predictable, controlled deployment Well tolerated hemodynamically No procedural deaths or strokes Excellent valve performance and low mortality at 30 days Improvements in LV volume, NYHA class, QOL at 30 days CE Mark Study / Expanded Global Feasibility Study US Pivotal in 2018

19 A Contemporary TMVR Paradigm W eary of careful patient selection inclusive chest and apex A nchoring to leaflets and annulus T ranseosophageal Imaging and TMVR Thrombosis C omplexities of leaflets, subvalvular apparatus H OCM and navigating LV and papillary muscle architecture O utflow tract and potential obstruction of anterior leaflet U nderstanding true pathoanatomic mechanism T eam decision making including Imager, Surgeon, IC

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