St. Jude Medical's Aortic Connector for Clampless Bypass Surgery Gaining Momentum After One Year On U.S. Market.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--May 23, 2002

More Than 25,000 Implants Worldwide for

Breakthrough Heart Bypass Device

St. Jude Medical's (NYSE:STJ) sutureless mechanical connector for coronary bypass surgery - the Symmetry(TM) Bypass System Aortic Connector - has been widely accepted by cardiac surgeons since receiving U.S. Food and Drug Administration (FDA) clearance on May 24, 2001.

More than 25,000 implants of the Aortic Connector have occurred worldwide, representing a new approach to coronary artery bypass grafting (CABG) surgery. Over 750,000 people undergo this common cardiac procedure every year.

The Symmetry(TM) Bypass System Aortic Connector is the market's first sutureless mechanical connector for CABG procedures. The device deploys in seconds, providing a precise and reproducible anastomosis (connection). The Aortic Connector allows cardiac surgeons to attach vein grafts to the aorta without using any aortic clamps or sutures, minimizing the manipulation of the diseased aorta during CABG surgery.

The ability to perform clampless aortic anastomoses may potentially reduce the risks associated with cardiac bypass surgery. Studies show that manipulating the aorta may cause cerebral and systemic embolization, a process where "debris" dislodges and flows to the patient's brain and other organs. This cerebral microemboli is believed to be a major cause of adverse neurological outcomes following surgery.

"This device allows us to keep manipulation of the aorta to an absolute minimum, which should potentially decrease the incidence of some of the subtle neurological side effects, such as memory loss and problems with fine motor skills, that are common after bypass surgery," said Dr. Lishan Aklog, Associate Chief of Cardiac Surgery at Mount Sinai Medical Center in New York City. "These connectors represent a major advance in coronary bypass surgery and are at the leading edge of a wave of new enabling technologies that are revolutionizing cardiac surgery."

A pilot study at Duke University Medical Center indicated that using the Symmetry(TM) Bypass System Aortic Connector in "off-pump" CABG procedures reduced the amount of cerebral microemboli 10-fold versus a patient-matched "on-pump" group and 2.5-fold versus a matched "off-pump" group with sutures. Both matched groups required full or partial clamping of the aorta, while the cases using the Symmetry(TM) Bypass System connector required no clamping.

In the past year, several studies have demonstrated the benefits of off-pump or beating heart surgery - procedures done without using a heart-lung machine. St. Jude Medical's Symmetry(TM) Bypass System may increase the number of clampless procedures, offering a simpler, faster approach to CABG surgery.

Some of the key studies reported in 2002 about the potential benefits of off-pump CABG surgery and their findings include:

-- A study reported in the April 6, 2002, British medical journal, Lancet,
showing that patients who underwent off-pump bypass surgery had significantly
fewer episodes of irregular heart beats, fewer chest infections, and shorter
hospital stays on average than patients who had conventional bypass procedures.


-- A team at the St. Francis Medical Center in Honolulu reported at the Asia
Pacific Scientific Forum, April 23-26, 2002, that patients did better on four
cognitive tests after off-pump CABG surgery than patients who were put on a
heart-lung machine.

-- A study presented at the American Association for Thoracic Surgery (AATS) on
May 6, 2002, demonstrated that patients who underwent off-pump CABG surgery did
just as well - and in some measures better - than those who had traditional
bypass surgery. The study from Crawford Long Hospital at Emory University in
Atlanta showed that patients who underwent the less-invasive procedure lost
less blood during surgery, had less damage to the heart muscle and left the
hospital a day earlier, on average, than those undergoing the conventional
method.

"A growing body of evidence supports the advantages of off-pump CABG surgery," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery business. "St. Jude Medical is developing a full line of mechanical connectors and delivery systems that will potentially enable an entirely sutureless bypass grafting procedure. We believe the simplicity of these technologies will increase the number of clampless bypass procedures, resulting in a significant improvement in patient outcomes."

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.