Important Safety Information for Patients
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
INDICATIONS FOR USE
The Enterra Therapy System for gastric electrical stimulation is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years.
The Enterra Therapy System is not intended for patients whom the physician determines are not candidates for surgical procedures and/or anesthesia due to physical or mental health conditions. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an Enterra device. Patients should not have Magnetic Resonance Imaging (MRI).
This system has not been evaluated for pregnant women, for use in patients under the age of 18, or patients over the age of 70. The system may be affected by or adversely affect cardiac devices. Strong sources of electromagnetic interference (EMI) such as from electrocautery, defibrillation/cardioversion, therapeutic ultrasound, radiofrequency (RF)/microwave ablation, or MRI, can result in serious injury, system damage, or operational changes to the system. EMI, postural changes, or other activities may cause shocking or jolting sensations. Patients on anticoagulation therapy may be at a greater risk for post-operative complications. The use of non-Medtronic components with this system may result in damage to Medtronic components, loss of therapy, or patient injury. There is the possibility of an allergic or immune system response to the implanted materials. When possible, a physician is to identify and treat any infections prior to surgery. Infections at the implant site almost always require the surgical removal of the implanted system. The lead can become entangled with the bowel or perforate your stomach and cause life-threatening blockage or infections that require immediate medical attention, and may require surgery.
Patients should avoid activities that may put undue stress on the implanted system components (activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching that can cause component fracture or dislodgment).
Adverse events related to the therapy, device, or procedure can include: infection, pain at the surgery site, device components may wear through the skin, bruising at the neurostimulator site, bleeding, loss of therapeutic effect, undesirable change in stimulation (described as a jolting, shocking, or burning sensation), gastrointestinal symptoms and gastrointestinal complications (in that the lead may perforate your stomach or device components may become entangled with or obstruct other internal organs, requiring surgery). The system could stop because of battery depletion or mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return.
Authorized by Federal law for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated.
For further information, please contact Enterra Medical.
WHAT IS A HUMANITARIAN DEVICE?
A humanitarian device is a medical device specially designated by the US Food and Drug Administration (FDA) for use in the treatment of a rare medical condition (fewer than 8000 new cases per year in the United States). The FDA requires that any physician who wishes to use the device to treat a patient must first obtain approval from the hospital’s institutional review board. The Enterra Therapy System was designated as a device for humanitarian use by the FDA in 1999.
After Enterra Therapy was designated for humanitarian use, a Humanitarian device exemption application was submitted to the FDA. This type of application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. However, it must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Also, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that the applicant could not otherwise bring the device to market. Once the FDA approved the Humanitarian Device Exemption in 2000, the Enterra Therapy System was then manufactured and distributed in the United States.
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Enterra Medical products is not intended for users in markets that do not have authorization for use.
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