Healthcare Industry News: heart valve
News Release - August 20, 2008
St. Jude Medical Announces FDA Approval of Arecibo Manufacturing PlantST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE: STJ ) today announced U.S. Food and Drug Administration (FDA) approval of the company’s new facility in Arecibo, Puerto Rico, for the manufacturing of pacemakers and cardiac leads.
The 150,000 square-foot facility, located in Arecibo’s Santana Industrial Park, will initially be used to produce St Jude Medical pacemakers and cardiac leads for domestic and international markets, and the company plans to begin manufacturing implantable cardioverter defibrillators (ICDs) at the facility late this year. The new plant will expand the company’s cardiac rhythm management manufacturing capacity and is expected to create at least 1,250 new jobs within the next three years.
The approval followed a six-month review that included an on-site evaluation by FDA inspectors.
“Our success in Puerto Rico reflects our commitment to the highest quality standards, so we are pleased to expand our manufacturing capabilities there,” said Daniel J. Starks, chairman, president and chief executive officer of St. Jude Medical. “The expansion of our Puerto Rico operations enhances our ability to provide life-saving devices to people around the world.”
The expansion in Puerto Rico follows other recent expansions at two St. Jude Medical manufacturing facilities in Sylmar, Calif., and Liberty, S.C., as well as the ongoing expansion at the company’s global headquarters in St. Paul, Minn.
In 1987, St. Jude Medical began operations in Puerto Rico with 25 employees at its current Caguas facility. The original 23,000 square-foot plant, which manufactured mechanical heart valves, has evolved with the company’s continuous development of new cardiovascular products, tripling its size and expanding its scope to manufacture more than 220 models of cardiovascular and cardiac rhythm management products that are exported to countries around the world.
The Caguas site will continue to manufacture mechanical heart valves and Angio-Seal™ vascular closure devices, and also is expected to add new product lines in the future.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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