Cherryames,
For your reading pleasure, I have cut an article from
www.medtronic.com website for you to peruse at your leisure. Hope this helps answer some of your questions.
Holly
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FDA Approves New Implantable Drug Pump for Use in Promising Colorectal Liver Cancer Treatment
Medtronic's IsoMed® Infusion System Also Receives U.S. Regulatory Approval for Use in Treating Chronic Pain
MINNEAPOLIS, July 24, 2000 -- A new implantable drug pump from Medtronic, Inc. (NYSE: MDT), today received approval from the U.S. Food and Drug Administration (FDA) for use in a promising colorectal liver cancer treatment that delivers cancer-fighting medication directly to the liver, the most common place for colon cancer to spread. The IsoMed® Constant-Flow Infusion System also received regulatory approval for use in delivering morphine sulfate directly into the spinal fluid as a treatment for chronic pain. For these therapies, it features the most accurate constant-flow, implantable drug pump now available to health care providers and patients.
Colorectal Liver Cancer Treatment
Colorectal cancer is the second-leading cause of cancer death in the United States, with approximately 160,000 new cases diagnosed each year. If detected early, it is highly curable; a colonoscopy remains the best and most definitive screening test. But half of the 160,000 patients will suffer recurrence; and in an estimated 70 percent of patients whose cancer comes back, the disease spreads to the liver, limiting the chances for survival beyond two years.
After surgery to remove liver tumors, direct infusion of chemotherapy agents into the liver -- a treatment called hepatic arterial infusion (HAI) therapy -- holds great promise for keeping the cancer in check. Estimates indicate that approximately 12,000 patients who develop liver tumors from colorectal cancer each year in the United States might benefit from HAI therapy.
"There are two reasons why patients respond better to treatment with the pump than to traditional treatment," according to Elin Sigurdson, M.D., director of surgical research at Fox Chase Cancer Center in Philadelphia. "First, the pump delivers the drug directly into the liver; it's not diluted in the blood. The second reason," explained Dr. Sigurdson, who has studied HAI therapy extensively for 20 years, "is that we can actually give much larger doses of the same type of drug than we can give systemically because the drug is cleared by the liver. As a result, response rates tend to be much higher."
For the treatment of patients with colorectal cancer that has spread to the liver, the Medtronic IsoMed® Constant-Flow Infusion System safely and accurately delivers high concentrations of floxuridine (FUDR) on a continuous basis directly to the liver through the hepatic artery, the main blood supply for liver tumors. The IsoMed drug pump is surgically placed under the skin of the abdomen and filled with the appropriate medication. A catheter that runs from the pump to the hepatic artery delivers medication at a constant rate from the pump into the liver.
Numerous studies conducted over the last 15 years suggest that HAI therapy -- administered alone or in combination with systemic chemotherapy after the surgical removal of liver tumors -- can significantly extend the lives of appropriately selected patients with colorectal liver cancer, decrease the recurrence of disease in the liver and improve quality of life.
"I'm confident that my doctor's recommendation of HAI therapy was the best course of action for me," said James Lewandowski, 58, of Langhorne, Pa., who was diagnosed with colon cancer in late 1998 and was implanted with the IsoMed Infusion System at Fox Chase Cancer Center at the end of January. "I'm still working full time; I'm still able to garden and do other chores around the house. My wife and I are looking forward to taking our boat on a cruise to the Chesapeake Bay in August."
The IsoMed Infusion System underwent clinical trials for its use in administering HAI therapy at 21 U.S. cancer centers, including Fox Chase Cancer Center in Philadelphia, Montefiore Medical Center in New York, Massachusetts General Hospital in Boston, Sinai Hospital of Baltimore, MD Anderson Cancer Center in Houston, Medical City Dallas Hospital, The Cancer Center at Century City Hospital in Los Angeles and the University of California San Francisco.