Larry L. Wood Corporate Vice President Edwards Lifesciences Update on the Commercial Launch of TAVR in the US: Site Selection, Training, Clinical Indications, Case Volumes & Clinical Outcomes Larry L. Wood Corporate Vice President Edwards Lifesciences
Disclosure Statement of Financial Interest I, Larry L. Wood, DO have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
FDA-Approved US Indications for TAVR November 2, 2011 October 19, 2012 3
Edwards US TAVR Site Activation Program Overview Selected Training Begins Patient Selection ~5 Cases Required for Fundamentals Room & Heart Team Readiness Follow Up Fundamentals Training Patients Screened Proctoring Begins Proctor Independence
Edwards TAVR Fundamentals Training Program TF Fundamentals Program TA Fundamentals Program DAY 1 DAY 1 DAY 2 TF Procedural Deep Dive– How to avoid, detect, manage PARTNER Data Review Technology Overview Multidisciplinary Team Setup PARTNER A Overview Technology Overview Patient Screening Taped Live-Case Device Demo & Simulation Pt Case Presentations Pt Screening Anesthesia Management Working Lunch Each site presents 2 cases TA Procedural Deep Dive Tips and Tricks Complication Mgmt, Best Practices Working Lunch Panel Q & A Procedure Room Setup Equipment, Staff Case Observation “Live” taped cases Procedural Deep Dive Device Demo & Simulation Pt Case Presentations CT and Echo Workshop
TAVR US Commercial Sites Trained 169 New TF Sites 103 New TA Sites New sites only: Excludes sites from The PARTNER Trial 6
1,450+ US HEART Team Members Trained HEART Teams 457 ICs 394 CTS’ 152 Echocardiographers 87 Anesthesiologists 51 OR/CCL staff members Support Teams Valve clinic coordinators Nurses Administrators Radiologists Cardiologists Vascular surgeons Valve clinic staff members Perfusionists Total: 314 support staff Minimum of 2 each per site New sites only: Excludes sites from The PARTNER Trial
US Commercial Sites Are Experienced Interventional & Surgical Centers PCI sAVR BAV PFO ASD/ VSD Perc. Mitral repair EVAR TEVAR LVAD 1,463 175 20* 23* 16* 12* 53* 13* *Average as-reported annual procedural volume at sites performing given procedure
US Commercial TAVR Cases More Than 5,000 Patients Treated Launch-to-Date
4 – 6 Cases To Independence (US Commercial Average) 144 TF proctor-independent sites 26 TA proctor-independent sites New sites only: Excludes sites from The PARTNER Trial
Edwards Is Committed To Partnering For Procedural Success SAPIEN-specific 3D reconstruction and measurement program Annular sizing & shape analysis Calcification location & loads Access path diagnostics Recommendations for obtaining perpendicularity 11
Post-Approval and Indication Expansion Efforts PAS2 – Post-Market Surveillance Tracking over 3,000 patients for 5 years Annual follow-up -- including echo TVT Registry Required by CMS for reimbursement All patients enrolled in US at all TAVR sites Allows for long term follow-up STS & ACC IDEs Alternative Access on-label & reimbursable for non-operable patients Valve in Valve and Alternate Access for high-risk patients pending
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