Healthcare Industry News: anastomosis system
News Release - April 16, 2007
Cardica Appoints Ric Ruedy Vice President of Regulatory, Clinical and Quality AffairsREDWOOD CITY, Calif., April 16 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that it has appointed Ric Ruedy vice president of regulatory, clinical and quality affairs. Mr. Ruedy brings to Cardica nearly 20 years of experience and a successful track record, including two original PMA approvals and multiple 510(k), IDE and PMA submissions for class I, II and III medical devices.
"Ric's extensive experience leading clinical and regulatory efforts both domestically and internationally will be instrumental as we work to increase the adoption of our C-Port system, pursue U.S. regulatory approval of our PAS- Port system and continue development of additional products based on our proprietary anastomosis technology," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc.
Mr. Ruedy joins Cardica from Abbott Vascular, where he was director of regulatory affairs for their endovascular and vessel closure business units, responsible for all regulatory operations for class II and III medical devices, including stents and stent grafts, closure devices and angioplasty catheters. He was responsible for all U.S. and international regulatory filings for these devices, and under his supervision, Abbott Vascular received two original PMA approvals in the same year. Prior to Abbott Vascular, Mr. Ruedy was vice president of regulatory, clinical and governmental affairs for Parallax Medical (acquired by ArthroCare Corporation), where he executed a corporate strategy for all domestic and international device approvals, registrations, clearances and licenses. Prior to Parallax Medical, Mr. Ruedy held escalating clinical, regulatory and quality assurance positions in multinational medical device companies, including Medtronic and Baxter Healthcare. Mr. Ruedy was also a co-founder of Acta Vascular Systems, a privately held neurovascular device company that recently merged with CardioVasc Inc. Mr. Ruedy received his bachelor of arts degree from Bucknell University.
About Cardica, Inc.
Cardica designs and manufactures automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica provides cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure.
Cardica's C-PortŪ Distal anastomosis systems are marketed in Europe and the United States. The PAS-PortŪ Proximal anastomosis system is marketed in Europe and Japan and is being evaluated in a pivotal trial in the United States and Europe. Cardica also is developing additional devices to facilitate vascular and other surgical procedures. Go to http://www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements relating to increased adoption of the C-PortŪ Distal anastomosis system, regulatory approval of the PAS-Port System, development of additional product candidates and other matters. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "believe," "plan," "expect," "estimate," "intend" and "will" or similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Cardica's results to differ materially from those indicated by these forward-looking statements, including risks associated with the degree of market acceptance for our products, receipt of regulatory approvals and development of additional products, as well as other risks detailed from time to time in Cardica's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended December 31, 2006. Cardica does not undertake any obligation to update forward-looking statements.
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