Healthcare Industry News:  neuromodulation 

Devices Interventional

 News Release - December 9, 2010

Results from CIRSE Multicenter Registry Reinforce Safety of St. Jude Medical Vascular Closure Device

Registry results confirm the excellent sealing performance of Angio-Seal vascular closure devices in interventional radiology procedures

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, commends the efforts of the investigators in the CIRSE Vascular Closure Device Registry, the world’s first multicenter registry aimed at assessing the performance of vascular closure devices in interventional radiology (IR) procedures.

With more than 1,100 patients enrolled at 28 centers in 10 European countries, the CIRSE registry validated the routine use of Angio-Seal™ vascular closure devices in IR, with successful deployment achieved in approximately 97 percent of procedures. The registry was conducted under the leadership of Principal Investigator Jim A. Reekers, M.D., Ph.D., professor of interventional radiology at the University of Amsterdam, The Netherlands, and confirmed that the use of Angio-Seal vascular closure devices in IR procedures is safe and effective with low incidence of serious complications.

“The CIRSE Vascular Closure Device Registry results provide physicians with an unbiased source of information that verifies the benefits of closure devices in interventional radiology procedures,” said Dr. Reekers. “The results offer strong clinical data that demonstrate the use of Angio-Seal vascular closure devices are safe and effective with outstanding deployment success rates.”

The Angio-Seal vascular closure device platform is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner than with manual compression.

Since its introduction to the market 15 years ago, more than 15 million Angio-Seal vascular closure devices have been utilized around the world. In addition, more than 325 studies have documented the potential benefits of Angio-Seal devices for physicians, patients and hospitals.

“This registry once again confirms the exceptional safety and efficacy profile of Angio-Seal, and adds to previous studies that have indicated increased lab efficiency, reduced procedural cost and improved patient outcomes as a result of the use of this technology,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “St. Jude Medical is pleased to see the benefits of our Angio-Seal vascular closure device reinforced by the results from the CIRSE registry, and we anticipate that these results will encourage the use of our Angio-Seal vascular closure device platform in IR procedures.”

Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is the European educational and scientific association for the support of IR. The organization aims at improving patient care through the support of teaching, science and research in the field of IR. CIRSE actively supports clinical trials and research development for the improvement of ethical, technical and material conditions in IR for enhanced patient care.

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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit

Forward-Looking Statements

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 Quarterly Report on Form 10-Q for the fiscal quarter ended October 2, 2010. 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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