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The Lotus Device Design & FIM Experiences with a Repositionable Self Expanding Percutaneous Aortic Valve Ian T. Meredith MBBS, BSc(Hons), Ph.D, FRACP,

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Presentation on theme: "The Lotus Device Design & FIM Experiences with a Repositionable Self Expanding Percutaneous Aortic Valve Ian T. Meredith MBBS, BSc(Hons), Ph.D, FRACP,"— Presentation transcript:

1 The Lotus Device Design & FIM Experiences with a Repositionable Self Expanding Percutaneous Aortic Valve Ian T. Meredith MBBS, BSc(Hons), Ph.D, FRACP, FACC, FCSANZ, FSCAI, FAHA, FAPSIC Professor and Director of Monash HEART Southern Health & Monash University, Melbourne Australia

2 Ian T Meredith, MD, PhD Honoraria: Abbott Vascular
Boston Scientific Corporation Medtronic, Inc.

3 All-cause mortality (%)
TAVR Clinical Results Encouraging PARTNER B: All Cause Mortality Standard Rx Hazard ratio, 0.55 (95% CI, 0.40–0.74) P<0.001 TAVI ∆ at 1 yr = 19.0% p<0.001 49.7% 30.7% All-cause mortality (%) Months Numbers at Risk TAVI 179 138 122 67 26 Standard Rx 121 83 41 12 Leon M, Smith C, Mack M, et al. NEJM 2010;363:

4 TAVR vs. AVR: Transfemoral Cost per QALY gained (Partner Cohort A)
∆ QALYs = ICER = dominant % dominant = 59.7 D 1-yr cost (TAVR - AVR) % <$50,000 per QALY = 74.7 Better QOL Less Expensive Complete Population M Reynolds, TCT 2011 D QALY (TAVR - AVR)

5 Current Clinical Concerns
Performance Paravalvular AR Size and Deliverability Learning Curve and Ease of Use Clinical Events Stroke Bleeding Vascular Complications Mortality by Grade of AR -Sinning JM, et. al., EuroPCR 2011 Leon M, ACC 2011

6 Current Technology Gaps
Matrix of Device Sizes Commercially Available Device Repositioning/retrievability Paravavular Leakeage Device Preparation challenges

7 Sadra-BSC Lotus™ Valve System
Second generation TAVR system designed to address gaps with first generation systems Valve pre-attached to delivery system Easy device preparation Repositionable – proximal or distal for controlled and accurate valve placement Retrievable at any point up to release Valve functions early in deployment Adaptive seal designed to minimize paravalvular leakage

8 Sadra-BSC Lotus™ Valve Delivery System
Easy to Prepare Pre-Loaded System Deploy, Lock Release Unlock, Retrieve Intuitive Handle Design 2 Controls Release

9 Sadra-BSC Lotus™ Valve Lotus™ Valve
Pre-Loaded System Locking Mechanism Enables operator control of implant Nitinol Frame Designed for retrieval and repositioning Bovine Pericardium Long-term proven material Adaptive Seal Designed to minimize perivalvular leaks

10 The Lotus™ Valve System Product Design Goal Attributes Compared to First Generation Devices
Edwards Sapien™ XT Medtronic CoreValve® BSC / Sadra Lotus™ Pre-loaded Delivery System Reversibility of Deployment partial 1 Bovine Tissue Leaflet Material (porcine tissue) ≤18F Profile Paravalvular Sealing Component 1 - Retrievable up to and including full deployment, and prior to the implant release from the delivery system. Other Sources: Edwards.com, Medtronic.com, Sadramedical.com; The Lotus Valve System is an investigational device, not available for sale. Sapien and CoreValve are investigational devices in the U.S., and not approved for sale. See Glossary

11 The Lotus™ Valve System Procedure Steps
Delivery Unsheathing Locking Assessment Release Final Result Release Images from Lotus Feasibility Study, 2010, HELIOS Klinikum Siegberg

12 The Lotus™ Valve System Repositionable and Retrievable
Complete assessment is performed while valve is fully locked and still attached to the delivery system Unlock Resheath Complete Recapture Enabling repositioning or full recapture

13 Sadra-BSC Lotus™ Valve 21 Fr FIM Study
10 patients enrolled: July 2007 – October 2008 6 patients implanted, 4 surviving Procedure time < 20 minutes No significant perivalvular leaks No valve migrations First patient implanted doing well 4 years after implant

14 Sadra-BSC Lotus™ Valve 21 Fr FIM – 1 Year Follow-up

15 Sadra-BSC Lotus™ Valve 18 Fr Feasibility Study
12 patients enrolled at 3 sites; 9 patients implanted with the Lotus™ Valve System First patient enrolled: April 13, 2010 at Essen Elisabeth by Prof. Grube Site # PI Pts Enrolled Pts Implanted 01 - Siegburg Dr. R. Mueller 4 02 - Essen Elisabeth Prof. E. Grube 2 03 - Essen University Prof. R. Erbel 3 Total 12 9

16 Sadra-BSC Lotus™ Valve 18 Fr Feasibility Study Demographics
Characteristic N=12 pts Age, years 84±3.8 Gender, Female 12 (100%) STS 7%±5.9 Euroscore 25%±9.6 NYHA Class III or IV EF 60%±7 CHF 2 (17%) CAD or CID 8 (67%) Hypertension Peripheral Vascular Disease 5 (42%)

17 Sadra-BSC Lotus™ Valve 18 Fr Feasibility Study– 1 Year Follow-up

18 The Lotus™ Valve System REPRISE I Feasibility Study
Objective Assess acute safety and performance of Lotus™ Valve System for TAVR in patients with aortic valve stenosis at high risk for surgical intervention Primary endpoint: Clinical procedural success, defined as device success without in-hospital MACCE Valve Size 23 mm valve  aortic annulus size mm Sites: Monash Medical Center Royal Adelaide St. Vincent’s Hospital Prof. Ian Meredith (Principal Investigator) Prof. Rob Whitbourn Prof. Stephen Worthley

19 The Lotus™ Valve System REPRISE II Clinical Trial
Objective Evaluate safety & performance of Lotus™ Valve System in patients with severe aortic stenosis at high risk for surgery Primary endpoint Device performance: 30-day Mean aortic valve pressure gradient Safety: 30-day all cause mortality Enrollment Up to 120 patients in Australia, France, Germany, UK Two valve sizes 23 mm  aortic annulus size mm 27 mm  aortic annulus size mm Rigor to support regulatory approvals

20 Sadra-BSC Lotus™ Valve REPRISE II Study
VARC endpoints and definitions Patient selection with Case Review Committee oversight Frailty: Nutritional assessment Grip strength Gait speed Activities of daily living Cognitive function Physical activity Comprehensive aortic valve and iliofemoral analyses Modified Rankin Score at baseline and all follow-up visits, 30-day and 90-day after a neurological event Long term QOL assessments (baseline, 6 mo, 1, 3 and 5 yrs)

21 REPRISE II Patients’ Screening - Valve and Femoral Anatomy
21

22 Conclusions TAVR results in  both symptomatic and prognostic improvement in elderly high risk patients with severe symptomatic aortic stenosis who would otherwise be treated medically Adverse events with first generation TAVR systems highlight opportunities to improve upon current outcomes The Lotus™ Valve System is designed to address many of the current challenges with first generation technology The REPRISE I and II clinical trials will assess the safety and performance of the Lotus Valve replacement system

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