Medtronic Supports Physician Report on Safety and Effectiveness of ''Beating Heart'' Bypass Surgery; Review of Evidence Shows Off-Pump Surgery Equal to Conventional Approach for Most Patients; More Appropriate for At-Risk Patients

Business Wire, Dec 1, 2005

MINNEAPOLIS -- Medtronic, Inc. (NYSE:MDT), an innovator in the development of medical instrumentation for surgery on the beating heart, today hailed a first-of-its-kind consensus statement issued by the International Society of Minimally Invasive Cardiothoracic Surgery presenting evidence that off-pump coronary artery bypass (OPCAB) surgery, or "beating heart" surgery, is as safe and effective as conventional coronary artery bypass graft (CABG) surgery in which the heart is stopped for repairs. And, the authors said, OPCAB may be better in some cases for patients that are poor candidates for traditional bypass surgery because of preexisting medical conditions such as diabetes, renal problems, and patient history of stroke or heart attack.

Conventional arrested-heart CABG surgeries utilize a complex perfusion circuit - usually called the "heart-lung machine" - to pump and oxygenate the patients' blood while the heart is stopped during the procedure. In OPCAB procedures, surgeons can avoid the perfusion system by employing advanced medical instruments that allow them to suture a graft on an isolated area of a beating heart.

The "Consensus Statement," authored by 12 of the world's leading cardiac surgeons and conducted according to American College of Cardiology and American Heart Association standards for the development of clinical practice guidelines, included conclusions based on a comprehensive analysis of existing worldwide published clinical evidence. The panel was chaired by Dr. John Puskas of Emory Crawford Long Hospital at Emory University, Atlanta. The review was supported by an unrestricted grant by Medtronic and other industry organizations.

"This effort represents the first and most extensive review of all studies related to OPCAB," said Puskas. "It's clear that this growing body of medical evidence collected over the past decade suggests that off-pump procedures are safe, effective and easier on the patient than conventional CABG surgery."

The authors acknowledge that a large prospective, randomized trial evaluating numerous endpoints will firmly answer outstanding questions regarding the relative merits of on- and off-pump surgical coronary revascularization, particularly in high-risk patients, but note that the rigorous meta-analysis of collected evidence allows several recommendations to be made.

Findings published in the Society's official publication state that OPCAB:

--should be considered a safe alternative to conventional bypass surgery with similar or reduced risk of mortality at 30 days with mixed-risk patients,

--is recommended in certain patient populations to reduce post-surgical problems such as stroke, heart attack, atrial fibrillation and renal failure, which are less likely to occur when grafting is done as the heart continues to beat,

--patients are less likely to experience neurocognitive dysfunction after 30 days (after a year, neurocognitive outcomes are about the same for each type of procedure),

--is recommended to reduce the length of stay in intensive care unit and in the hospital, and

--should be considered for use on high-risk patients.

"Once again, there is a persuasive story to the benefits of beating heart surgery," said Dr. Oern Stuge, Medtronic senior vice president and president, Medtronic Cardiac Surgery. "We expect that more physicians will continue to embrace, and more patients will continue to request, this surgical approach."

Approximately 350,000 U.S. patients undergo coronary artery grafting operations every year. Currently, approximately 25 percent of the general population and 30 percent of the Medicare cases are being performed off-pump.

The Medtronic Octopus(R) System, a combination of devices including the eighth-generation Octopus tissue stabilizer and its partner, the Starfish(TM) or Urchin(TM) heart positioner have been used on more than 400,000 patients worldwide. The devices use innovative suction stabilization technology to hold, lift and rotate the beating heart to expose coronary arteries on any of its surfaces, and then hold the tissue almost stationary where the surgeon is working.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

EDITOR NOTE: Physicians are available for interviews to discuss experience with beating-heart surgery in most major markets. Broadcast quality video and animation also is available. Contact Rich Fischer at 763-505-2975 to arrange interviews or request footage.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results.