UNITED STATES | INTERNATIONAL
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INDICATIONS FOR USE: The TriVascular Ovation Abdominal Stent Graft System is indicated for use in subjects diagnosed with an aneurysm in the abdominal aorta with small aortic diameters and access vessels of less than 7 mm in diameter, having vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; a non-aneurysmal proximal aortic neck with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 15.5 mm and no greater than 17.4 mm, and with an aortic angle of d 60 degrees if proximal neck is > 10 mm and < 45 degrees if proximal neck is < 10 mm; adequate distal iliac landing zone with a length of at least 10 mm, with an inner wall diameter of no less than 8 mm and no greater than 17 mm.

CONTRAINDICATIONS: The TriVascular Ovation Abdominal Stent Graft System is contraindicated indicated for use in patients who have a condition that threatens to infect the graft and patients with sensitivities or allergies to the device materials. Also consider the information in Section 4 Warnings and Precautions of the systems Instructions for Use.

Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

HUMANITARIAN DEVICE Authorized by Federal law for use in the treatment of abdominal aortic aneurysms. The effectiveness of this device for this use has not been demonstrated.

Leadership

Michael V. Chobotov, Ph.D.

Michael V. Chobotov, Ph.D.
President, Chief Executive Officer; Co-founder

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Michael co-founded TriVascular in 1998, and serves as President and CEO. Michael and his co-founders Robert Whirley and Joseph Humphrey also developed the business and technical strategies for the successful re-launch of TriVascular, following its re-emergence from Boston Scientific in 2008. In his role as President and CEO, Michael led TriVascular’s original platform technology and corporate conception, private venture financings, strategic partnership and acquisition by Boston Scientific, as well. Prior to co-founding TriVascular in 1998, as its President/CEO he co-founded TransMotive Technologies, an engineering and product development consulting company with unique capabilities for computer simulation and analysis of complex mechanical, structural, and dynamic phenomena in a variety of industries, including medical devices. Previously, Michael served as Senior Vice President of R&D and board member of U.S. Electricar, and also led the design of the Lunar Prospector spacecraft (subsequently licensed to Lockheed Martin). Michael began his career with Hughes Aircraft Company as a systems engineer.

Michael holds a Ph.D. in Mechanical Engineering, an M.S. in Mechanical Engineering and a B.S. in Engineering and Applied Science, all from the California Institute of Technology.
Robert G. Whirley, Ph.D.

Robert G. Whirley, Ph.D.
Vice President, Research and Development; Co-founder

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Robert co-founded TriVascular in 1998, and serves as Vice President, Research and Development. Robert and his co-founders Michael Chobotov and Joseph Humphrey also developed the business and technical strategies for the successful re-launch of TriVascular, following its re-emergence from Boston Scientific in 2008. During his tenure at TriVascular, Robert has worked closely with the CEO in business planning and fund-raising for all financing rounds. His strong relationships with key opinion leaders and clinicians have helped him lead the development of products aligned with their needs. In previous roles Robert has served as Vice President of Engineering for TransMotive Technologies, Vice President of Technology R&D for U.S. Electricar, and President of Livermore Research and Engineering Corp. Robert previously served as a Research Engineer and Lead Developer at Lawrence Livermore National Laboratory and in technical roles at TRW.

Robert holds a Ph.D. in Mechanical Engineering from California Institute of Technology, a M.S. in Applied Mechanics from California Institute of Technology, and a B.S. in Mechanical Engineering from Georgia Institute of Technology.
Joseph W. Humphrey, Ph.D.

Joseph W. Humphrey, Ph.D.
Vice President, Manufacturing Technology; Co-founder

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Joe co-founded TriVascular in 1998, and serves as Vice President of Manufacturing Technology. Joseph and his co-founders Michael Chobotov and Robert Whirley also developed the business and technical strategies for their successful re-launch of TriVascular, following its re-emergence from Boston Scientific in 2008. During his tenure at TriVascular, Joe has held numerous positions including Vice President of Administration, CFO, and CIO. Prior to TriVascular, Joe co-founded TransMotive, where he served as Vice President of Technology. In prior roles, Joe served as Vice President of Programs for U.S.Electricar, Co-founder and President of Advanced Projects Research Inc., and Research Scientist at the Marquardt Company. Joe began his career at Aerojet Propulsion Research Institute.

Joe holds a Ph.D. in Mechanical Engineering from the California Institute of Technology, a M.S. in Mechanical Engineering from California Institute of Technology and B.S. degree in Mechanical Engineering from the Georgia Institute of Technology.
Shari L. Allen

Shari L. Allen
Vice President, Clinical/Regulatory Affairs and Quality Assurance

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Shari joined TriVascular in September 2009 as Vice President: Clinical, Regulatory & Quality. In this role, Shari leads the development and execution of global clinical studies, regulatory approvals, and quality programs. Shari joined TriVascular most recently from Aptus Endosystems where she served as the Vice President of Clinical and Regulatory. Her aortic and peripheral vascular experience also includes leadership roles at Bard Peripheral Vascular and W.L. Gore & Associates. Shari began her career as a consultant at Quintiles Medical Technology Consultants where she specialized in developing global clinical and regulatory strategies for commercialization of implantable cardiovascular devices.

Shari holds dual bachelor’s degrees in Chemistry and Biology from the University of Virginia.
Vivek K. Jayaraman

Vivek K. Jayaraman
Vice President, Commercial Operations

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Vivek joined TriVascular in October 2009 as Vice President, Commercial Operations. In this role, Vivek leads Global Marketing, Sales and Business Development. Vivek joined TriVascular from Medtronic, where he spent 8 years in roles of increasing leadership responsibility. Most recently, Vivek served as the Vice President of Global Marketing for Medtronic’s EVAR franchise and helped lead them to worldwide market share leadership. In previous roles, Vivek managed the global P&L for Medtronic’s Peripheral Vascular franchise, worked as a Policy Fellow in Medtronic’s Government Affairs Office in Washington, D.C., and served as an expatriate in Hong Kong, SAR and Tokyo, Japan leading the gastroenterology and urology franchise. Vivek joined Medtronic in business development supporting the Neurological and Diabetes sector. Prior to Medtronic, Vivek worked at the Johnson & Johnson Development Corporation. Vivek began his career as a consultant with The Wilkerson Group, a healthcare focused management consultancy.

Vivek holds an MBA in Healthcare Management from The Wharton School at The University of Pennsylvania and dual bachelor’s degrees in Biology and History from the University of Michigan.
Michael R. Kramer

Michael R. Kramer
Chief Financial Officer

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Mike joined TriVascular in September 2010 as Chief Financial Officer. In this role, Mike leads the Finance and Administrative functions—including IT, Human Resources and Legal. Prior to joining TriVascular, Mike was Chief Financial Officer at ATS Medical, a publicly traded cardiovascular device Company until its sale to Medtronic in August 2010. While at ATS Medical, he oversaw two acquisitions and led several debt and equity financings. His career includes Controller at CABG Medical, Inc.— a cardiovascular device manufacturer, and Corporate Finance Manager at Ecolab, Inc.—a developer and marketer of products and services to the hospital, foodservice, healthcare and industrial markets. Prior to entering industry, he was a manager in the assurance and advisory services practice at the professional services firm of Ernst & Young LLP.

Mike holds a Bachelor of Accountancy from the University of North Dakota.
Lou J. Molinari

Lou J. Molinari
Vice President: Manufacturing Operations

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Lou joined TriVascular in July, 2004. Lou brings over 25 years of experience in Operations, Manufacturing, and Engineering Management to TriVascular. Prior to TriVascular, he held the position of Director of Operations for Brooks Automation. Lou also held the position of Director of Manufacturing/Process Development Engineering for TriVascular as well as Boston Scientific. Previously, Lou has held positions in various industries including medical devices, semiconductor equipment, telecommunications components, disk drive manufacturing, and power generation.

Lou received a bachelor’s degree in Electrical Engineering from California Polytechnic University, San Luis Obispo.