St. Jude Medical Announces Global Launch of Next-Generation Angio-Seal Vascular Closure Device at 2003 Transcatheter Cardiovascular Therapeutics Conference.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 15, 2003

3 Million Angio-Seal Devices Sold

St. Jude Medical, Inc. (NYSE:STJ) announced today the global launch of the Angio-Seal(TM) STS Plus, the Company's latest-generation vascular closure device at the 2003 Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. The TCT Conference brings together clinicians from around the world, providing an arena for discussion and discovery of the latest techniques and technologies. The Company also announced shipment of the 3 millionth Angio-Seal(TM) device.

Angio-Seal(TM) is the number one vascular closure device used worldwide. The STS Plus offers enhancements to St. Jude Medical's Angio-Seal(TM) STS Platform, with more efficient device positioning, smoother arterial access and other new features. Following a phased launch that began in late August 2003, St. Jude Medical anticipates rapid acceptance of this enhanced technology by clinicians.

The St. Jude Medical Angio-Seal(TM) STS Plus device is offered in both 6 and 8 French sizes and is indicated for use in closing femoral arterial puncture sites following diagnostic or interventional catheterization (cath) procedures. It builds on the STS Platform, which features a self-tightening suture that allows the arterial closure procedure to be completed in the catheterization lab. The STS Platform offers clinicians vascular closure technology that is very reliable and easy to use. Its introduction was instrumental in propelling the Angio-Seal(TM) device to its current number one market position.

The STS Plus launch benefits by momentum created by new labeling which demonstrates how the Angio-Seal(TM) STS device significantly reduces the time to patient ambulation and discharge following diagnostic procedures. The labeling results from a prospective clinical study, which demonstrated that 35 percent of patients ambulating in less than five minutes and the majority ambulating within 10 minutes. The U.S. Food and Drug Administration (FDA) approved labeling includes clinical data that shows many diagnostic patients can be safely ambulated in less than 20 minutes and discharged one hour post-ambulation when a 6F Angio-Seal(TM) device is used. No other vascular closure device can make such claims.

The Angio-Seal(TM) STS Plus incorporates design enhancements to further simplify deployment technique and provide optimal patient outcomes. A redesigned arteriotomy locator and insertion sheath system allows for improved positioning of the insertion sheath in the artery prior to deployment. The new arteriotomy locator system also reduces the chance of arterial trauma, helping maintain optimal conditions for effective and consistent mechanical closure.

"Catheterization labs are under constant pressure to improve productivity and decrease costs," said David W. Adinolfi, President of St. Jude Medical's Daig business. "That's why we constantly analyze their tools and processes to find opportunities for improvement. Providing rapid hemostasis was a big step. But today's Angio-Seal(TM) device also offers faster ambulation and discharge, factors which can dramatically reduce costs and increase patient comfort."

The cost savings offered by the Angio-Seal(TM) device were demonstrated in a June 2003 economic model created by St. Jude Medical and Deloitte & Touche. The model demonstrates how return on investment (ROI) per $1 spent using Angio-Seal(TM) devices could be as high as $3.49 depending on case mix and device use scenarios. This study was cited in the August 29, 2003, issue of the Advisory Board's The Cardiovascular Watch as follows: "Changes in the technology's design have made closure devices safer and easier to use, and the increase in outpatient caths--along with capacity crunches--has rendered the economic situation surrounding the devices more favorable. Data from one manufacturer show that using closure devices in cath-based procedures could afford a significant ROI for hospitals (St. Jude Medical report, 6/16/03). Roundtable analysts note that other institutions could realize similar gains, if cath lab processes are optimized (Cath Lab Performance, 2003)."

"St. Jude Medical has shown continuous dedication to improving the speed and effectiveness offered by Angio-Seal(TM)," continued Adinolfi. "Improving the simplicity and reproducibility of deployment is one key way of accomplishing that goal. The introduction of our fifth-generation device, paired with clinical studies and FDA-approved labeling that supports earlier ambulation and discharge, helps clinicians to maximize the effectiveness of vascular closure while maintaining a foundation for safe, efficient patient treatment. The shipment of our 3 millionth Angio-Seal(TM) device is an important milestone for this market-loading St. Jude Medical product. Only 30% of catheterization procedures currently utilize closure devices, but the technology is rapidly becoming the standard of care in many hospitals around the world."

The original Angio-Seal(TM) device received U.S. Food and Drug Administration (FDA) approval in September 1996, and became the industry's number one closure device in early 2002. Since acquiring the technology in 1999, St. Jude Medical has introduced four iterations of the product. The newly refined Angio-Seal(TM) STS Plus design, which had a phased launched in August 2003 and is being launched globally this week, has already gained broad market acceptance and reinforced the Angio-Seal(TM) product line's number one market share in the industry.

Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2002 (see pages 6-8). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.