St. Jude Medical Launches New Vascular Closure Device; Angio-Seal(TM) VIP Effectively Seals Arteries in Both Diagnostic and Interventional Procedures.
The new device, which is approved for both diagnostic and interventional procedures, gives physicians an improved method for sealing arterial catheterization access sites. Because the new device provides more coverage on the artery surface than previous devices, physicians may more effectively achieve hemostasis (cessation of bleeding), even in patients using certain blood thinners. In addition, the device's coated suture makes it easier to use, enhancing physicians' ability to effectively seal access sites. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 centimeter of the original site.
"In our experience with Angio-Seal VIP, which includes use in more than 550 patients, we believe that the improvements have been noticeable, particularly in interventional procedures," said Dr. Jack Martin, FACC, FESC, Chief of Cardiology, Main Line Health, Bryn Mawr, Penn. Dr. Martin was involved in pre-market evaluation of the new technology. "Also, we believe that earlier patient ambulation and earlier discharge helps patients get back to their lives sooner, as well as reducing time and cost in the recovery room."
Unlike other vascular closure devices, all components of the Angio-Seal VIP are fully absorbed within 60 to 90 days, so no foreign material permanently remains in the body. These components include a small anchor, collagen and a suture. The anchor is placed in the artery through a small delivery system, where it is pulled against the inside wall of the artery. The anchor and collagen are gently "sandwiched" together with the suture to form a secure seal.
Nearly 10 million catheterizations are performed worldwide each year, in which a thin tube is inserted into the femoral artery in the leg. Prior to the introduction of vascular closure devices, patients were required to endure 15 to 30 minutes of uncomfortable manual pressure at the leg's access site, followed by 4 to 12 hours of bed rest, to ensure that hemostasis was maintained. This required increased time in the catheterization lab and recovery area, longer hospital stays and more monitoring by clinical staff, thereby increasing associated costs.
"The ability to have patients become mobile sooner is better for patient comfort as well as for staff productivity," said Dan Howell, Nurse Manager of Ross Ambulatory Care Center, Richard M. Ross Heart Hospital, Columbus, Ohio.
St. Jude Medical is the market leader in vascular closure devices with procedures using predecessors of the Angio-Seal VIP device (Angio-Seal STS or Angio-Seal STS Plus). Compared to traditional manual pressure and other vascular closure devices, patients with Angio-Seal devices are able to resume normal activity more quickly. In diagnostic cases, most patients are able to walk within 20 minutes and leave the hospital one hour later.
The Angio-Seal VIP device also has received European CE Mark approval and is available in many countries globally. It maintains the same clinical and productivity benefits of previous Angio-Seal devices.
"Due to its benefits for patients, physicians and hospitals, Angio-Seal has been the leader in the vascular closure market for the past several years," said Paul R. Buckman, President of St. Jude Medical's Cardiology Division. "We anticipate Angio-Seal VIP will further reinforce this market leadership and become the standard of care for vascular closure."
More than 7 million Angio-Seal devices have been distributed since the product was first marketed in 1996. For more information about Angio-Seal, visit www.sjm.com.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology, and neuromodulation. Headquartered in St. Paul, Minn., the company employs approximately 10,000 people worldwide. 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 anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success. 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 the Cautionary Statements described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on page 15). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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|Date:||Mar 17, 2006|
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