Healthcare Industry News:  cardiopulmonary 

Devices Surgery Cardiology FDA

 News Release - April 13, 2006

Medtronic Enters Heart-Lung Machine Market with Most Advanced, Compact Circulatory Support System

Medtronic Performer(TM) CPB System Designed to Support Evolving Cardiac Procedures

MINNEAPOLIS--(HSMN NewsFeed)--April 13, 2006--Medtronic, Inc. (NYSE:MDT ) today announced U.S. Food and Drug Administration clearance for the Medtronic Performer(TM) cardiopulmonary Bypass System (CPB), an integrated, compact console capable of providing total support of the circulatory system during a variety of cardiac surgical procedures. Though offering all the functionality of existing systems, it occupies only a 20-inch by 22-inch space, just a third of the footprint of the time-honored "heart-lung" consoles.

"The Performer integrates all of the components that Medtronic has to offer with an innovative pumping system in a small footprint and features that are controlled on a touch-screen," said Brian McCloskey, chief of clinical perfusion, Foothills General Hospital Calgary, Alberta. "Together with the Medtronic Resting Heart(TM) System (RHS), it is an excellent package providing an effective way to run an advanced mini-circuit on a small pump base. It takes up significantly less OR space and helps with coordination of all of the monitoring devices I work with."

The Medtronic Performer CPB responds to the spatial demands in today's operating room, providing convenient access for perfusionists. With disposables at operating-table height, and providing monitoring, pumping, controlling, filtration, air handling, or cardioplegia functions as needed, the Performer CPB, when used with smaller biocompatible circuits like the Medtronic Resting Heart® System, offers a new approach to reducing morbidity of cardiac surgery.

Michael Harostock, M.D., chief of cardiothoracic surgery at Wilkes-Barre General Hospital in Wilkes-Barre, Pa., reports 250 patients at the institution have undergone heart surgery using the Medtronic Resting Heart® System.

"Compared with a similar group, the blood utilization decreased 27% and indicated a decrease in the overall transfusion rate by 37% in people who came to the operating room with a hematocrit of less than 35%," said Harostock. "Now, thanks to this new machine, our patients have access to the best heart and lung technology available. The major benefit to our bypass patient is that it results in a safer and more healthful surgery."

With the Performer CPB, Medtronic becomes the only company offering a comprehensive product line supporting nearly any cardiac surgical procedure the physician chooses for each individual patient - stopped-heart, beating-heart, and valve surgery, with or without concomitant surgical ablation.

"Medtronic is committed to developing medical advances that meet the needs of the patient and his or her surgical team," said Oern Stuge, president, Medtronic Cardiac Surgery. "This industry-leading extracorporeal support system facilitates those procedures and is upgradeable to accommodate new procedures into the future."

The new system, which has evolved from proven extracorporeal support technologies, incorporates the Medtronic Bio-Pump® Plus in the arterial position - which plays the role of the heart when the blood must be routed outside the body - as well as four peristaltic-type roller pumps for non-arterial fluid delivery and retrieval functions. System controls support individual pump function and a central information display with color touch-screen incorporates graphic menus and buttons for user-selectable options. The system monitors all functions pertinent to patient physiology during use and its servo safety technologies provide visual and audible signals and alarms as needed. Height is electrically adjustable, allowing the instrument to be placed closer to the patient.

The Performer CPB also incorporates data management functions to capture, display, store and transmit all key instrument-related perfusion parameters throughout an entire operation. Data can be transmitted from the system to an external Microsoft® Office Excel-based macro program for report and graph generation and case records.

The new system enables Medtronic Cardiac Surgery to continue its leadership in offering the world's most complete product portfolio to facilitate improved outcomes in arrested heart surgery and demonstrates a commitment to invest in innovate technologies to support perfusionists, surgeons and ultimately, patients. For more information about Medtronic Cardiac Surgery products, visit the Medtronic website at

About Medtronic

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

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.

Source: Medtronic

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