Medical Device Daily Associate

A new smaller heart-lung bypass device developed by Medtronic (Minneapolis) has the potential to provide the space-challenged operating room (OR) with an alternative to traditional room-hogging models.

The company reported that the FDA has cleared its Performer 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 traditional “heart-lung“ consoles.

According to Tom Shannon, a senior product manager at Medtronic, the Performer system responds to the spatial demands in today's OR, providing convenient access for perfusionists.

Shannon told Medical Device Daily that the system is able to save space in the OR because it is designed with a vertical pumping system, as opposed to the more commonly used horizontal pump.

“This was a way to cut the space down,“ said Shannon. “Because you're not laying it out in a console that's laid out like a table, it's laid up and down like a column that's adjustable in height up and down.“

With disposables at operating-table height, and providing monitoring, pumping, controlling, filtration, air handling, or cardioplegia functions as needed, Shannon noted that the Performer CPB, when used with smaller biocompatible circuits like the company's Resting Heart system, offers a new approach to reducing morbidity of cardiac surgery.

“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 at Foothills General Hospital (Calgary, Alberta). “Together with the Medtronic Resting Heart system, 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.“

Michael Harostock, MD, chief of cardiothoracic surgery at Wilkes-Barre General Hospital (Wilkes-Barre, Pennsylvania), reported 250 patients at his institution have undergone heart surgery using the company's RHS device.

“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 said it 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.“

The system, which has evolved from extracorporeal support technologies, incorporates the company's 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 that incorporates graphic menus and buttons for user-selectable options. The company said 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 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.

Asked if there is truly a need for a new heart-lung bypass machine in the wake of increased beating-heart surgery, Shannon said the industry perception is that the beating-heart trend spiked several years ago and there has been a gradual return to arrested heart procedures.

And the arrested heart procedures have “more advanced features and safety enhancements that allow for better outcomes for the patient,“ he said. “What [surgeons] are doing is going back to bypass with smaller circuits and more efficient systems with enhanced safety features to rule out some of the things that in the past have been issues with going on bypass.“

While declining to give a specific price for the system, Shannon said it was “comparable“ to existing heart-lung machines on the market. He said these systems have an industry-wide price range of $100,000 to $150,000.