1. REPRISE I The Sadra Lotus Valve for TVAR
Ted Feldman, M.D., FSCAI FACC FESC
Evanston Hospital
CRT
Cardiovacular Research Technologies
Washington, D.C.
February 23rd–26th 2013

2. Ted E. Feldman, MD Consulting: Abbott Laboratories
Boston Scientific Corporation
Edwards Lifesciences, LLC

3. The Lotus™ Valve Design Features Pre-loaded Valve 18F Delivery System
23mm & 27mm Diameter
Accurate Placement & Repositionable
True Retrievability
Negligible Aortic Regurgitation
Deploy Retrieve
Release
The Lotus™ Valve System is an investigational device, not for sale

4. The Lotus™ Valve System
The Lotus™ Valve System is an investigational device, not for sale

5. Lotus Valve Designed for Controlled Deployment
Radiopaque center marker
Valve expands radially as it shortens for radial strength and flexibility
Valve functions early in deployment for controlled positioning
Repositionable and fully retrievable before release if initial positioning is suboptimal
Adaptive seal designed to minimize paravalvular aortic regurgitation

6. Lotus™ Valve Deployment Phases
1. Elongated Configuration (for Delivery)
2. Intermediate Configuration
20mm
25mm
3. Final Locked Configuration
23mm
27mm
40mm
35mm
19mm
23 mm Valve
27 mm Valve
23 mm Valve
27 mm Valve
The Lotus Valve System is an investigational device, not available for sale.

7. REPRISE I Key Inclusion Criteria
Age ≥70 years
Documented calcified native aortic stenosis
AVA <1.0 cm² (or AVA index <0.6 cm²/m²) plus either MPG >40 mmHg or jet velocity >4 m/s (by echocardiography)
High risk for surgical AVR
STS score ≥8% or euroSCORE ≥20% or documented heart team agreement of high risk due to frailty or comorbidities
Symptomatic aortic valve stenosis with NYHA Class ≥II
Aortic annulus size mm
23 mm valve size used in study
AVA=aortic valve area; MPG=mean pressure gradient; NYHA=New York Heart Association; STS=Society of Thoracic Surgeons

8. REPRISE I Study Organization
Clinical
Sites
Clinical Events Committee
Sergio Waxman, MD (Interventional Cardiologist, Chair)
Carey Kimmelstiel, MD (Interventional Cardiologist)
Gregory Smaroff, MD (Cardiothoracic Surgeon)
Roberto Rodriguez, MD (Cardiothoracic Surgeon)
Viken Babikian, MD (Neurologist)
Echocardiography Core Laboratory
Victor Davila-Román, MD CVR Consulting, St. Louis, MO, USA
Electrocardiography Core Laboratory
Peter J. Zimetbaum, MD
Harvard Clinical Research Institute, Boston, MA, USA

9. Baseline Patient Characteristics REPRISE I
Patients (N=11)
Age (Years)
83.0±3.6
Gender (Female)
11/11
STS Score (%)
4.9±2.5
Logistic euroSCORE (%)
9.5±4.4
NYHA Class III or IV
5/11
Diabetes, medically treated
2/11
Hypertension, medically treated
10/11
History of coronary artery disease
History of PCI or CABG
History of cerebrovascular accident
Atrial fibrillation
Values are mean±SD or n/N
CABG=coronary artery bypass graft; PCI=percutaneous coronary intervention; STS=Society of Thoracic Surgeons

10. REPRISE I Procedural Characteristics (N=11) Measure Outcome
Lotus Valve implanted
11/11
Symptomatic coronary obstruction
0/11
Successful valve repositioning, if attempteda
4/4
Successful valve retrieval, if attempteda
N/A
a: Secondary endpoint

11. Primary Endpoint – Discharge/7 Days REPRISE I
Patients
Clinical Procedural Success (per patient)
9/11
Device Success
10/11
Successful access, delivery, deployment, valve positioning, delivery system retrieval
11/11
Intended valve performancea
One valve implanted
No MACCE through discharge or 7 daysb
a: AVA >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate/ severe prosthetic valve aortic regurgitation
b: Major adverse cardiovascular or cerebrovascular events including all-cause mortality, peri-procedural MI ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction

12. Patient Details REPRISE I Primary Endpoint
Patient A: Post-Procedure Major Ischemic Stroke
Parieto-temporal, left MCA branch
mRS = 3 at discharge and 2 at 90 days
Also left femoral dissection treated with balloon angioplasty (VARC Safety Composite)
Patient B: Gradient / Velocity Criterion Not Met
Valve functioning well, no regurgitation
Core Lab Measures
Discharge
90 Days
Mean Gradient
22 mmHg
12.9 mmHg
Peak Velocity
328 cm/s
245 cm/s
Aortic Valve Area
1.6 cm2

13. Aortic Regurgitation with TAVR
Eccentric Annulus + Concentric Valve = Paravalvular Regurgitation
Lotus™ Valve Adaptive™ Seal
mitigates Aortic Regurgitation
The Lotus™ Valve System is an investigational device, not for sale

14. REPRISE 1 – Aortic Regurgitation Transthoracic Echocardiography
Ian Meredith, AM, MBBS, PhD at TCT 2012

15. First Lotus™ Valve Patient (Age 98 yrs): Five Year Follow-up (June 2012)
The Lotus™ Valve System is an investigational device, not for sale

16. Case Study MonashHeart
Demographics
88 year old man, No CAD
Height/Weight
166 cm, 84 kg, BMI 30.5
Medical history
Myelodysplasia and atypical CLL
Hb 102, Haematologist has estimated prognosis at very worst as 3.5 – 5.7 years
Asthma
FEV1 0.96L (47%)
DLCO 9.8 (45%)
T2DM
Obesity
Hypertension
Renal impairment
Cr 140
STS score
Mortality 4.4%, Morbidity 25.7%
STS plus factors
Pulm HTN mmHg +5%
FEV cc +5%
euroSCORE 2011
27.1%

17. Deploy & Recapture 23mm

18. 23mm vs 27mm

20. The Lotus Aortic Valve Program
3M data reported
REPRISE I
Pre-CE Mark Feasibility Trial
11 patients, 3 sites (AU), 23mm valve
Primary endpoint: Clinical procedural success (acute device performance without in-hospital MACCE)
Enrolling
REPRISE II
CE Mark Trial
120 pts, 15 sites (AU, FR, DE, UK), mm valves
Primary endpoint: Device performance at 30 days (mean valve gradient) + safety endpoint (all-cause mortality)
REPRISE III
Pivotal IDE Trial (PMA)
Inoperable, high-risk and moderate-risk pts, sites TBD (US, AU, EU, Japan), mm valves
Primary endpoint: composite safety & effectiveness
The REPRISE Program is sponsored and funded by Boston Scientific Corporation.
The Lotus Valve System is an investigational device, not available for sale.