Registry results confirm the excellent sealing performance of Angio-Seal
vascular closure devices in interventional radiology procedures
ST. PAUL, Minn., Dec 09, 2010 (BUSINESS WIRE) --
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(TM)
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
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 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 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, Inc.
St. Jude Medical, Inc.