FDA grants MR conditional use to Enterra’s electrical stimulation device for gastroparesis
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The FDA has granted conditional use with magnetic resonance imaging to Enterra Medical’s implantable electrical stimulation device for management of symptoms associated with gastroparesis, according to a company release.
The Enterra II system, specifically its component parts Enterra 37800 Neurostimulator and Enterra Therapy 4351-35 unipolar leads, is intended to relieve symptoms associated with gastroparesis, including nausea and vomiting, the company noted. The system uses gastric electrical stimulation to deliver electrical pulses to the nerves and smooth stomach muscles to control symptoms.
“We are hopeful that the ability to perform MRI examinations will bring patients one step closer to relief from their nausea and vomiting symptoms with Enterra Therapy. - Kenneth Koch, MD
“This is a significant milestone in our journey to increase innovation in this therapeutic area and to help people living with gastroparesis find relief,” Peter Sommerness, CEO of Enterra Medical, said in the release.
Medtronic had originally developed Enterra Therapy in 2000, when it was granted FDA approval as a humanitarian device, the release stated. With the expanded MR conditional labeling, patients who had previously received the Entera II System can “safely undergo MRI examinations of the head or upper/lower extremity under certain conditions.”
“For people living with gastroparesis who have considered Enterra Therapy in the past, the ability to have MRI scans may have been an important factor in their decision,” Kenneth Koch, MD, vice president and medical director of Enterra Medical, said in the release “We are hopeful that the ability to perform MRI examinations will bring patients one step closer to relief from their nausea and vomiting symptoms with Enterra Therapy. We remain passionately focused on helping all gastroparesis patients take back their seat at the table.”
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