Medtronic Octopus 4.3 device offers new refinements to facilitate surgery on the beating heart

Minneapolis 23 January 2004Continuing its leadership in significant new technologies for bypass grafting surgery on the beating heart, Medtronic Inc. has launched the worldwide commercial release of the Medtronic Octopus 4.3 Tissue Stabilizer. With more than 325.000 of its market-leading predecessor Octopus devices used by the world's surgeons since the innovative instrument was introduced in 1997, Medtronic demonstrated significant new refinements at meetings of the Society for Thoracic Surgeons in San Antonio.

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The new Octopus 4.3 device embodies the latest innovations in tissue stabilization technology. First the Medtronic Starfish2 or Urchin heart positioner lifts and positions the heart. Next, the Octopus 4.3 device uses suction to gently hold small areas of cardiac surface tissue nearly motionless as the heart continues to beat. This allows the surgeon to suture grafts in place to carry blood flow around artery blockages.

A flexible headlink and redesigned turret for the Octopus 4.3 device are engineered to facilitate surgeon access to all target vessels, then provide best-in-class stability with reinforced arm links, turret and clamp design. Though precise and stable, the low arm profile and turret manoeuverability afford advanced levels of visualization.

"It is much stronger than other stabilizers I have used", stated Steven Hoff, M.D., who used the new device at St. Thomas Hospital, Nashville, Tennessee, last week. "Stabilization and accessibility are critical in bypass surgery, and the Octopus 4.3 device takes another big step ahead. I'm certain that it will provide new levels of confidence to surgeons and reduce operating room time for patients."

Dr. Stuart Miller, cardiac surgeon at Albany, New York, Medical Center, also noted improvements in stability during his recent procedures with the new Octopus 4.3 device. "The new device incorporates the best features of the earlier versions and adds greater arm strength, stability and easier access to the various areas of the heart. It enhances what already was my preferred approach in bypass cases."

The improved device comes amid growing clinical evidence that coronary artery bypass grafting surgery on the beating heart is safe, effective and easier on the patient than conventional bypass procedures performed with the time-honoured "heart-lung machine". The now well-established techniques, and the developing technologies, eliminate the need for an external perfusion circuit to pump oxygenated blood through the body while the heart is stopped for grafting. It is estimated that 25 percent to 29 percent of the estimated 350.000 coronary artery bypass grafting (CABG) procedures that take place annually in the United States are now performed "off-pump".

Accumulating clinical evidence demonstrates comparable graft revascularization, or blood flow, the key indicator of effectiveness. In a study comparing results of 200 patients randomly assigned to beating-heart or stopped-heart CABG surgery, John Puskas, M.D., cardiac surgeon at Crawford Long Hospital of Emory University, Atlanta, reported in the Journal of Thoracic and Cardiovascular Surgery that beating-heart surgery "off-pump" achieved similar completeness of revascularization, similar in-hospital and 30-day outcomes, shorter length of stay, reduced transfusion requirement, and less injury to heart muscle. (Puskas J. et. al., Off-pump coronary artery bypass grafting provides complete revascularization with reduced myocardial injury, transfusion requirements, and length of stay: A prospective randomized comparison of two hundred unselected patients undergoing off-pump versus conventional coronary artery bypass grafting. Journal of Thorac and Cardiovascular Surgery 2003; 125: 797-808)

In a statistical study of randomized and non-randomized research, a team headed by James T. Reston, Ph.D., of the Department of Health Technology Assessment, ECRI, reported in the Annals of Thoracic Surgery that their meta-analysis found rates of myocardial infarction, stroke, reoperation for bleeding, renal failure and mortality rates that were lower by statistically significant levels after off-pump grafting than after similar procedures with the heart-lung machine. (Reston, et. al., Meta-analysis of short-term and mid-term outcomes following off-pump coronary artery bypass grafting. Annals of Thoracic Surgery 76:1510-1515)

Bob Guezuraga, president of Medtronic Cardiac Surgery, noted that each advancement in Medtronic instrumentation for beating heart surgery provides new options for the surgeon. "The launch of the Octopus 4.3 stabilizer signals Medtronic's continued commitment to making beating heart surgery easier and offering the surgeon a choice between the two best tissue stabilizers on the market. The Octopus 4.3 device will offer 90-degree flexibility with it split-ball headlink, while the Octopus 4 device features an ultra low-profile design. Both offer unsurpassed stability through arm, turret and clamp."

Medtronic Cardiac Surgery offers the world's most complete product portfolio to facilitate beating heart surgery. More news is available in this VMW issue's article Medtronic releases two left-heart delivery systems designed to help navigate challenging heart anatomies.


Leslie Versweyveld

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