Lessons Learned from the TVT Registry Experience Larry Wood Corporate Vice President/General Manager Transcatheter Heart Valves Edwards Lifesciences

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.

The Unique Promise of TAVR Source: Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007, Freed 2010, Iung 2007, Pellikka 2005, Internal estimates

The Unique Promise of TAVR Monday AM Tuesday AM Tuesday PM 5:30PM: Around Family Dinner Table At Son’s House in Phoenix, AZ Morning After TAVR Breakfast in ICU

The Unique Promise of TAVR Heart Team

Establishing the TVT Registry 2010 February 2011: Discussions between FDA, ACC and STS July 2011: TVT Registry proposed at the FDA Advisory Panel for Edwards Sapien Valve September 2011: ACC and STS filed a request with CMS for a NCD for transcatheter valves November 2011: Edwards Sapien THV approved in U.S. Dec 2011: STS/ACC TVT Registry launched May 2012: CMS issued a NCD for transcatheter valves mandating participation in a national registry as a requisite for reimbursement July 2012: Web-based data entry portal opened 2011 2012 2013 2014 2015

TVT Registry Successes Created, operated, and funded by a collaborative model of different stakeholders including FDA, CMS, professional societies, and medical device industry Provided ability to assess and monitor dispersion of technology Expanded indications Potential to streamline adverse event monitoring

But It Isn’t Free… Burden of data collection: > 300 data elements Significant resources needed to support registry needs >$3M per year Potential for misinterpretation and misuse of data Long-term sustainability Start up cost for 350 sites > $10M Maintenance cost >$7M per year

Sustainability Requires Innovation Sustainable TVT Registry Replace Existing Systems Medical Device Reporting (MDR) Tracking of hospital quality measures Leverage Data for New Indications Continue to use data to support indication expansion in order to help address undertreated patient population . Eliminate Redundancy Expand Indications Streamline Data Collection Simplify Data Entry Further reduce down to essential fields Optimize EHRs: move to data capture vs. data input

What Does Success Looks Like? Once the government mandate goes away…