Healthcare Industry News: Millennium
News Release - August 21, 2007
St. Jude Medical Announces Japanese Approval of the Angio-Seal STS Plus Vascular Closure DeviceST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, for the Angio-Seal(TM) STS Plus Vascular Closure device.
Angio-Seal STS Plus is designed to provide physicians with an improved method of sealing catheterization sites, allowing patients increased comfort and offering hospitals improved efficiencies. Approved for both percutaneous peripheral and cardiac interventional catheterization procedures, the device enables physicians to quickly seal femoral artery punctures made during those procedures.
The device offers a significant advantage over the Angio-Seal Millennium vascular closure platform, which has been used in Japanese catheterization labs since 2004. With the addition of a self-tightening suture, the Angio-Seal STS Plus allows vascular closure to be completed entirely in the catheterization lab, saving labor and reducing the length of time required to complete the procedure.
Nearly 10 million catheterizations are performed worldwide each year. In these procedures, a catheter, or thin tube, is inserted into the femoral artery in the leg. Physicians then deliver diagnostic tools or interventional therapies, such as balloons, stents and medications, through the catheter to the point of treatment.
The Angio-Seal STS Plus device offers quick, consistent and predictable hemostasis (cessation of bleeding) at the puncture site. Its fast, secure closure reduces the risk of complications and can allow patients to resume activities sooner than if managed with manual compression.
"Japanese approval for the Angio-Seal STS Plus device will further reinforce the strong worldwide market position that the Angio-Seal system holds," said Paul Bond, president, St. Jude Medical Japan Co., Ltd. "Since 1996, more than 9 million Angio-Seal devices have been distributed and more than 250 studies have documented their benefits to doctors, patients and hospitals. These findings, and the experience of thousands of physicians around the world, are helping to establish the Angio-Seal device as the standard of care in vascular closure."
The Angio-Seal STS Plus device includes a small bio-resorbable anchor, suture and collagen pad. The anchor is placed in the artery through a small delivery system and secured against the artery's interior wall. Then the collagen pad, which is positioned on the outside of the artery, is bound together with the suture to form a secure seal. The self-tightening suture enables the physician to finalize the closure procedure immediately. Unlike many other vascular closure devices, all components of the Angio-Seal STS Plus device are fully absorbed with 60 to 90 days, so no foreign material permanently remains in the body.
If physicians need to repeat catheterization at a later time, they can re-access the original site, within one centimeter, when the Angio-Seal STS Plus device has been used to close the original site.
Prior to the introduction of vascular closure devices, patients were required to endure 15 to 30 minutes or more of uncomfortable manual pressure at the catheter's access site in the leg, followed by four to 12 hours of bed rest, to ensure that hemostasis was maintained. This typically required increased time in the catheterization lab and recovery area, longer hospital stays, more monitoring by clinical staff and, thereby, increased costs.
St. Jude Medical is a market leader in vascular closure devices and offers multiple platforms including Angio-Seal STS Plus and Angio-Seal VIP devices. These devices are available in many countries globally and provide many clinical and productivity benefits. Compared to traditional manual pressure and other vascular closure devices, patients treated with Angio-Seal devices generally 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.
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., St. Jude Medical employs approximately 12,000 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 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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on August 9, 2007 (see pages 26-29). 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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