FDA Green Lights Medtronic, Inc. System To Treat Serious Stomach Disorder
Medtronic Introduces Enhanced Therapy to Treat Debilitating Symptoms of Serious Stomach Disorder
FDA-Approved System May Provide Long-Term Symptom Relief for Patients Suffering from Gastroparesis
MINNEAPOLIS - January 23, 2015 -Medtronic, Inc. (NYSE: MDT) today announced it has received United States Food and Drug Administration (FDA) approval, under a humanitarian device exemption* (HDE),for the Medtronic Enterra® II System. The system is used to treat chronic, intractable (drug-refractory) nausea and vomiting associated with gastroparesis of diabetic or unknown origin when more conservative treatments fail or cannot be tolerated.
Gastroparesis is a serious and debilitating condition with no known cure in which the stomach muscles work poorly or not at all. It has many possible causes and is of particular concern to the increasing U.S. diabetes population,i as it is estimated to affect about five percent of people with diabetes.ii
Medtronic Enterra Therapy consists of a small medical device called a neurostimulator, which is implanted under the skin, usually in the lower abdominal region. Two insulated wires, called leads, are implanted in the stomach wall muscle and then connected to the neurostimulator, which delivers mild electrical pulses through the leads to stimulate the smooth muscles of the lower stomach. After the device is implanted, the doctor uses a handheld, external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs. Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer.
While Medtronic Enterra Therapy has been available to patients since 2000, the new Enterra II System improves the therapy by providing physicians with greater system flexibility and ease of use. The Enterra II System features improved programming software, improvements to the system's battery-life indicator, and a customized tool that simplifies implantation of the device for physicians.
Henry P. Parkman, M.D., Professor of Medicine at Temple University School of Medicine, and Director of the GI Motility Laboratory at Temple University Hospital, is one of the first to use the Enterra II System. Neither Dr. Parkman nor any member of his immediate family has any financial interest in Medtronic.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting," said Dr. Parkman. "The new advanced system simplifies the implantation process and is easy to program."
"Medtronic Enterra Therapy is a well-established treatment option, and we are pleased to make the new Enterra II System available to physicians and patients," said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. "These therapy enhancements are the latest examples of our ongoing commitment to provide physicians with a therapy that eases life-altering gastroparesis symptoms and enables patients to more comfortably participate in the things they enjoy."
Enterra Therapy has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Complications related to the device also can occur and may require additional surgery. Additional information on Medtronic Enterra Therapy is available at www.enterratherapy.com.
About HDEs
Humanitarian Use Devices (HUDs) facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of a "Humanitarian Device Exemption" (HDE) application, a company must demonstrate the product's safety and probable benefit in lieu of a product's safety and effectiveness. For any center in the United States to be able to offer this gastric electrical stimulation therapy option (the Medtronic Enterra II System), approval is required from an Institutional Review Board (IRB), a committee that approves, monitors, and reviews research within that center.
About Temple Health
Temple University Health System (TUHS) is a $1.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System (TUHS) and by Temple University School of Medicine. TUHS neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with TUHS member organizations. Each TUHS member organization is owned and operated pursuant to its governing documents.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
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FDA-Approved System May Provide Long-Term Symptom Relief for Patients Suffering from Gastroparesis
MINNEAPOLIS - January 23, 2015 -Medtronic, Inc. (NYSE: MDT) today announced it has received United States Food and Drug Administration (FDA) approval, under a humanitarian device exemption* (HDE),for the Medtronic Enterra® II System. The system is used to treat chronic, intractable (drug-refractory) nausea and vomiting associated with gastroparesis of diabetic or unknown origin when more conservative treatments fail or cannot be tolerated.
Gastroparesis is a serious and debilitating condition with no known cure in which the stomach muscles work poorly or not at all. It has many possible causes and is of particular concern to the increasing U.S. diabetes population,i as it is estimated to affect about five percent of people with diabetes.ii
Medtronic Enterra Therapy consists of a small medical device called a neurostimulator, which is implanted under the skin, usually in the lower abdominal region. Two insulated wires, called leads, are implanted in the stomach wall muscle and then connected to the neurostimulator, which delivers mild electrical pulses through the leads to stimulate the smooth muscles of the lower stomach. After the device is implanted, the doctor uses a handheld, external programmer to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs. Medtronic Enterra Therapy can be turned on and off at any time using the physician programmer.
While Medtronic Enterra Therapy has been available to patients since 2000, the new Enterra II System improves the therapy by providing physicians with greater system flexibility and ease of use. The Enterra II System features improved programming software, improvements to the system's battery-life indicator, and a customized tool that simplifies implantation of the device for physicians.
Henry P. Parkman, M.D., Professor of Medicine at Temple University School of Medicine, and Director of the GI Motility Laboratory at Temple University Hospital, is one of the first to use the Enterra II System. Neither Dr. Parkman nor any member of his immediate family has any financial interest in Medtronic.
"Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting," said Dr. Parkman. "The new advanced system simplifies the implantation process and is easy to program."
"Medtronic Enterra Therapy is a well-established treatment option, and we are pleased to make the new Enterra II System available to physicians and patients," said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. "These therapy enhancements are the latest examples of our ongoing commitment to provide physicians with a therapy that eases life-altering gastroparesis symptoms and enables patients to more comfortably participate in the things they enjoy."
Enterra Therapy has risks similar to any surgical procedure, including swelling, bruising, bleeding, and infection. Complications related to the device also can occur and may require additional surgery. Additional information on Medtronic Enterra Therapy is available at www.enterratherapy.com.
About HDEs
Humanitarian Use Devices (HUDs) facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of a "Humanitarian Device Exemption" (HDE) application, a company must demonstrate the product's safety and probable benefit in lieu of a product's safety and effectiveness. For any center in the United States to be able to offer this gastric electrical stimulation therapy option (the Medtronic Enterra II System), approval is required from an Institutional Review Board (IRB), a committee that approves, monitors, and reviews research within that center.
About Temple Health
Temple University Health System (TUHS) is a $1.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System (TUHS) and by Temple University School of Medicine. TUHS neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with TUHS member organizations. Each TUHS member organization is owned and operated pursuant to its governing documents.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Help employers find you! Check out all the jobs and post your resume.