Clinical Data Validate Angio-Seal Vascular Closure Systems' Successful
15-Year History with More Than 15 Million Angio-Seal Devices Distributed
ST. PAUL, Minn., Sep 21, 2010 (BUSINESS WIRE) --
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced subset data results for the Angio-Seal(TM) Evolution(TM)
Vascular Closure Device Registry. The results reaffirm the excellent
sealing performance of the Angio-Seal Evolution vascular closure device
in patients undergoing routine diagnostic and interventional cardiac
The Angio-Seal Evolution Device Registry presented at the Transcatheter
Cardiovascular Therapeutics (TCT) 2009 Conference, was the first
large-scale registry to follow more than 1,000 patients undergoing
closure with the Angio-Seal Evolution vascular closure device post
catheterization procedures via femoral artery access. The results
validated the exceptional performance of the Angio-Seal Evolution device
after being successfully deployed in 99.7 percent of procedures and with
hemostasis (cessation of bleeding) achieved in 97.8 percent of these
procedures by the device. This new subset analysis strengthens those
findings by demonstrating no significant difference in deployment
success or hemostasis for patients with challenging conditions that
might negatively impact device performance, such as obesity and scar
tissue at the vascular access site.
"The Angio-Seal Evolution Vascular Closure Device Registry results
demonstrate the benefits Angio-Seal Evolution provides for my patients
and cath lab staff," said Dr. Robert Applegate, M.D., Cardiologist at
Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "With
51.5 percent of patients in the registry having scar tissue at the
vascular access site and 48.6 percent of patients clinically diagnosed
with obesity, the registry and subset analysis provide strong clinical
data that demonstrate the Angio-Seal Evolution has excellent safety and
efficacy in challenging patient subsets."
The Angio-Seal Evolution device 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 quickly, enabling the patient to walk
and resume activities sooner than with manual compression.
Since its introduction into the market 15 years ago, more than 15
million Angio-Seal vascular closure devices have been distributed around
the world. In addition, more than 325 studies have documented the
benefits of Angio-Seal devices for physicians, patients and hospitals.
"The results presented by the subset analysis data confirm the
outstanding sealing performance of our Angio-Seal Evolution vascular
closure device," said Frank Callaghan, president of the St. Jude Medical
Cardiovascular Division. "The results also demonstrate St. Jude
Medical's ongoing commitment to providing best in class vascular access
and closure technologies worldwide."
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 April 3, 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.
J.C. Weigelt, 651-756-4347
Kate Stoltenberg, 651-756-6293