'Octopus4' From Medtronic Achieves New Technological Heights to Aid Surgery On Beating Heart.

Business Editors & Health/Medical Writers

MINNEAPOLIS--(BW HealthWire)--Aug. 14, 2002

Joins 'Starfish2' in Supporting CABG Procedures

That Reduce Transfusions, Complications

Amid growing evidence that coronary artery bypass grafting (CABG) surgery on the beating heart is safe, effective and easier on the patient than conventional CABG surgery with the time-honored "heart-lung machine," Medtronic, Inc., (NYSE:MDT) today announced commercial release of the Octopus(R)4 device, which is designed to make rapidly evolving surgical techniques on the beating heart easier.

The new Octopus4 device embodies the latest innovation in tissue stabilization technology, joining the Medtronic Starfish(TM)2 heart positioner, which was launched in May. Together they form the new Medtronic Octopus System II, which features added flexibility and lower profiles that improve the surgeon's access to, and view of, target arteries on any surface of the heart. The Octopus4 stabilizer attaches to the heart with suction to gently hold small areas of cardiac surface tissue nearly motionless, providing excellent stabilization as the surgeon sutures grafts that bypass artery blockages.

Surgery on the beating heart represents a major medical advancement because it eliminates the need for an external perfusion circuit - the "pump" or heart-lung machine - which pumps oxygenated blood through the body when the heart must be stopped for repairs. Use of this perfusion circuit has been the "gold standard" for more than 30 years. However, because of its complexity and potential risks, combined with the accumulating positive outcomes data about patients who have undergone beating heart surgery, an increasing number of surgeons are opting to avoid the perfusion circuit when possible. Use of beating heart techniques has grown more than 40 percent each year since 1997. It is estimated that 25 percent of the 350,000 CABG procedures that take place annually in the United States are now performed "off-pump."

Heightened interest in beating heart surgery, which is associated with less blood loss than surgery with the perfusion circuit, has coincided with shortages of banked blood across the nation, as well as increased costs of transfusions and the risk of bloodborne diseases. In a study comparing results of 200 CABG patients, John Puskas, M.D.,(1) cardiac surgeon at Crawford Long Hospital of Emory University, Atlanta, reported in the Annals of Thoracic Surgery that, while 70 percent of patients who underwent surgery with the perfusion circuit required transfusions, only 33 percent of beating heart patients required banked blood. Another study of 8,400 patients, supporting those results, was published in the same journal with Mitchell J. McGee, M.D.,(2) of the Cardiopulmonary Research Science and Technology Institute, Dallas, as lead author.

Other persuasive outcome measurements have concentrated on critical long-term factors:

Can grafts be sutured as well while the heart continues to beat as when it has been stopped? Do the bypass grafts stay open? Early and mid-term rates of unobstructed flow after beating heart CABG surgery have now been shown by several studies to be equal to or better than those of traditional pump techniques. In a study of 90 patients, a team headed by W. Douglas Boyd, M.D.,(3) at London Health Sciences Center, University of Western Ontario, Canada, found 100 percent of all grafts performed on the beating heart stayed open. Similar results came from an Italian team headed by Antonio Calafiore, M.D.,(4) at the University G. D'Annunzio.

Can surgery on the beating heart avoid physiologic stresses and complications - heart and brain damage - that have been associated with use of the perfusion circuit during heart surgery? Accumulating evidence suggests an advantage for beating heart techniques. Prof. Anno Diegeler of the University of Leipzig, Germany, reported that, "The off-pump technique appears to be promising in order to eliminate (emboli that are) the source of these neuropsychologic impairments following CABG operation."(5) John M. Murkin, M.D.,(6) of the University of Western Ontario, published similar findings related to both short- and intermediate-term postoperative followup periods.

At the same time, clinical reports also note that beating heart surgery is less costly in many cases. Dr. Puskas noted that his patients spent less time in the intensive care unit and, in many instances, their total hospital stay was shorter than that of patients who had been placed on the perfusion circuit during surgery.

"Octopus System II addresses the access, visibility and stabilization issues - all critical in performing beating heart CABG - in a very effective way," said Albert J. Pfister, M.D., of Washington (DC) Hospital Center. "Equally important, the outcomes we're seeing give us added assurance that CABG surgery on the beating heart is the preferred approach for a growing number of our patients.

"My entire O.R. team is excited about the ease of setup, the low profiles that help surgeons and their assistants work with more precision, and the ease of applying the Octopus4 device to the heart surface. When good technique meets good technology, the result makes everyone feel good."

Bob Guezuraga, president of Medtronic Cardiac Surgery, noted that each advancement in Medtronic instrumentation for beating heart surgery reinforces surgeon confidence and extends use of the proven techniques. "Medtronic intends to be fully responsive to the cardiac surgeon - whatever technique is used. We are continually improving tools and technologies to help ensure that all outcomes continue to be as positive as the results we are seeing for beating heart procedures. While the Octopus System II represents the state of the art today, I assure you that Medtronic Cardiac Surgery Technologies will continue its pioneering leadership in this area."

The new Octopus II system offers:

Secure, stable access to all coronary arteries. Using gentle suction, the Starfish gently lifts, positions, and holds the beating heart, enabling the surgeon to easily access any surface for optimal positioning with minimal negative impact on the patient's hemodynamic condition. A new swivel headlink and high-flow flexible tubing greatly increase positioning options.

Stabilization of tissue at the grafting site. The smaller, more flexible arm and turret-mounted design of the Octopus4 device make it easier to access all vessels for complete revascularization. Automatic, controlled tissue spreading of the malleable suction pods assures easy application, wider exposure and solid capture of the surface tissue where the surgeon will suture the graft.

Improved visibility. The overall reduced profile of the devices minimizes clutter in the surgical field, while the downsized control components, the turret, and a single vacuum line reduce obstructions for the surgical team.

Easier, quicker setup. The system's tubing set incorporates an in-line fluid collection canister that minimizes the potential for vacuum leaks in the suction lines and simplifies setup by making it unnecessary for operating room staff to provide and connect their own canister.

Medtronic Cardiac Surgery offers the world's most complete product portfolio to facilitate beating heart surgery as well as conventional procedures using the external perfusion circuit. For more information about Medtronic Cardiac Surgery products, visit the Medtronic Cardiac Surgery website at www.medtronic.com/physician/cardsurgery.html.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 26 2002. Actual results may differ materially from anticipated results.

(1) Puskas J. et al. Clinical outcomes, angiographic patency, and resource utilization in 200 consecutive off- pump coronary bypass patients. Ann Thorac Surg 2001:71:1477-1484. n = 200 OPCAB / 1,000 CPB 

(2) McGee M. et al. Elimination of cardiopulmonary bypass improves early survival of multi-vessel coronary artery bypass patients. Ann Thorac Surg 2000; 73:1196 - 1203. n = 1,983 OPCAB / 6,466 CPB

(3) Boyd WD, et al. Off-pump surgery decreases post-operative complications and resource utilization in the elderly. Ann Thorac Surg. 1999; 67:450-456. n = 106 OPCAB / 227 CPB

(4) Calafiore A, et al. Multiple arterial conduits without cardiopulmonary bypass: early angiographic results. Ann Thorac Surg.1999; 67:450-456. n = 106 OPCAB / 227 CPB

(5) Diegeler A, et al. Neuromonitoring and neurocognitive outcome in off-pump vs. conventional coronary bypass operation. Ann Thorac Surg. 2000; 69:1162-1166. n = 20 OPCAB / 20 CPB.

(6) Murkin J. et al. Beating heart surgery: why expect less central nervous system morbidity? Ann Thorac Surg. 1999; 68:1498-1501. n = 35 OPCAB / 33 CPB