DEERFIELD, Ill., September 29, 1998 — Baxter Healthcare Corporation, the principal U.S. operating subsidiary of Baxter International Inc. (NYSE:BAX), announced today that it has received pre-market approval from the U.S. Food and Drug Administration (FDA) for its Novacor® Left Ventricular Assist System (LVAS) in the United States as a bridge to heart transplant. Significantly, the approval also allows patients to live outside of the hospital while awaiting transplantation. The Novacor LVAS is an implantable, electric device that supports circulation in patients with heart failure by taking over the workload of the heart's main pumping chamber.
"This important milestone presents the possibility of new hope and a higher quality of life for many patients suffering from end-stage heart disease," said Michael A. Mussallem, Baxter group vice president. Mussallem noted that while an estimated 40,000 American cardiovascular patients under age 65 could benefit from a heart transplant each year, a severe organ donor shortage has resulted in fewer than 2,400 patients actually receiving transplanted hearts. "Many patients die," he added, "while waiting for a suitable donor organ to become available."
" In an ideal situation, if you have severe heart failure, you can reach up on the shelf and put a new heart in somebody and have a heart transplant. Unfortunately, we don’t have anything on the shelf in the natural form for cardiac replacement," said Robert Kormos, M.D., director of the Artificial Heart Program and Adult Cardiac Transplantation at the University of Pittsburgh. "The Novacor LVAS is the next best thing to a natural heart that you can pull off the shelf, put in somebody and provide normal function to someone who is dying.
"I am now able to offer relatively normal life to some patients who would otherwise be dead," continued Dr. Kormos, who participated as a principal investigator in the clinical trials. "Prior to implantation of the Novacor system, more than 90 percent of our patients are bedridden. After the system is implant, they’re up and walking, usually within two or three days."
The Novacor LVAS has been marketed in Europe since 1994 as both a bridge to transplant and a long-term alternative to other medical therapies, such as chronic drug treatment and heart transplantation. Among the nearly 900 individuals worldwide who have received the Novacor LVAS, two recipients in Europe recently surpassed three years of continuous support with their original devices, while three others in Europe and the United States have exceeded the two-year mark, and 27 additional patients have been supported longer than one year. The system’s portability has allowed hundreds of these patients to return home, where they often resume their normal work and leisure activities while awaiting availability of their donor hearts.
How it Works
Baxter’s Novacor LVAS is an electromechanically driven pump, about the size of a human heart that is implanted in the abdomen. The LVAS connects to the patient’s left ventricle, the heart’s main pumping chamber, and provides circulatory support by taking over most of the workload of the failing heart. An inflow circuit directs blood from the left ventricle into the blood pump. The pump ejects blood through an outflow conduit into the body’s arterial system.
The system is operated and monitored by an electronic controller and powered by primary and reserve battery packs, which are worn on a belt around the individual’s waist or carried in a shoulder bag. The controller and batteries are connected to the implanted pump by a percutaneous lead (a small tube containing several wires) through a patient’s skin. The system is completely self-regulating, responding and adjusting instantaneously to the patient’s changing heartbeat and circulatory demands. When a Novacor patient walks briskly, for example, the heart naturally beats faster and so does the pump, responding immediately to the change in heartbeat.
"Our engineers and scientists, along with leading cardiovascular clinicians, have worked for decades to advance this technology, to produce a system that is durable, reliable and easy for patients to use," said Peer M. Portner, Ph.D., LVAS technology pioneer and chairman of Baxter’s Novacor unit.
"Our ultimate goal has always been to evolve into a totally implantable system that would serve as a long-term alternative to other medical therapies like chronic drug treatment and heart transplantation."
"The unfortunate reality is that donor organs will always be in short supply. And as the number of patients with end-stage cardiovascular disease increases, the need for alternative treatment options will become more acute," added Tom Kelly, president of Baxter’s Novacor unit.
Baxter International is a global medical products and services company that focuses on critical therapies for life-threatening conditions. Baxter’s products and services in blood therapies (biopharmaceuticals and blood collection, separation and storage devices), cardiovascular medicine, medication delivery and renal therapy are used by health-care providers and their critically ill patients in 112 countries.
Baxter’s CardioVascular Group provides a wide range of technologies to treat patients with advanced cardiovascular diseases, encompassing perfusion products and services; critical care monitoring devices, heart valve replacement and repair products; cardiac assist systems, and catheters and technologies for surgical treatment of peripheral vascular disease.