Medtronic gets FDA clearance for compact circulatory support system

By Elaine Rigoli

Tampa, Fla., April 13 - Medtronic, Inc. announced Food and Drug Administration clearance for the Medtronic Performer Cardiopulmonary Bypass System, an integrated, compact console that supports the circulatory system during a variety of cardiac surgical procedures.

Medtronic said it is 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, in a statement.

"This industry-leading extracorporeal support system facilitates those procedures and is upgradeable to accommodate new procedures into the future."

The new system 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, according to a news release.

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 machine takes up a mere 20-inch by 22-inch space, the release said.

Medtronic, headquartered in Minneapolis, develops medical technology.

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