Healthcare Industry News: vascular closure
News Release - September 21, 2010
St. Jude Medical Announces Results from Angio-Seal Evolution Vascular Closure Device Registry Subset Analysis
Clinical Data Validate Angio-Seal vascular closure Systems’ Successful 15-Year History with More Than 15 Million Angio-Seal Devices Distributed GloballyST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced subset data results for the Angio-Seal™ Evolution™ 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 catheterization procedures.
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.
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 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
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