St. Louis Park, MINN.— October 25, 2023—Enterra Medical, Inc., an innovator in treatments for people living with gastroparesis, announced today that the Enterra® II System has been granted MR Conditional approval from the United States Food and Drug Administration (FDA).
The Enterra II System (specifically its component parts Enterra 37800 Neurostimulator and Enterra Therapy 4351-35 unipolar leads) is an advanced treatment system, designed to relieve the nausea and vomiting symptoms associated with gastroparesis—a complex medical condition that prevents the stomach from emptying properly.
The MR Conditional label means that patients who receive or have received the Enterra II System in the past can safely undergo Magnetic Resonance Imaging (MRI) examinations of the head or upper/lower extremity under certain conditions.
“This is a significant milestone in our journey to increase innovation in this therapeutic area and to help people living with gastroparesis find relief,” said Peter Sommerness, Chief Executive Officer of Enterra Medical.
“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,” said Kenneth Koch, MD, Vice President and Medical Director of Enterra Medical. “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.”
About Enterra® Therapy
Enterra Therapy was originally developed by Medtronic and approved by the FDA as a Humanitarian Device in 2000. A unique therapy called Gastric Electrical Stimulation (GES), Enterra Therapy delivers mild electrical pulses to the nerves and smooth muscles of the stomach to control the chronic nausea and vomiting symptoms associated with gastroparesis. To learn more about Enterra Therapy visit the company’s website and follow us on LinkedIn.
About Enterra Medical
Enterra Medical was founded in 2022 to help people living with chronic nausea and vomiting find the relief to take back their seat at the table. For help navigating diagnosis and considering the treatment options that are right for you, visit www.enterramedical.com.
Important Safety Information
Intended Use: The Enterra® Therapy System is an implanted device that provides gastric stimulation to treat chronic, intractable, nausea and vomiting that is not well treated by drugs or other means in patients aged 18 to 70 years caused by diabetes or an unknown origin.
Contraindications: Enterra Therapy is only for patients who are healthy enough for surgical procedures and/or anesthesia. Once implanted, patients need to avoid diathermy, which is deep heat treatment from electromagnetic energy, as it may cause injury or device failure.
Warnings: Enterra Therapy has not been studied in pregnant women, patients under the age of 18, or over 70. Issues may occur if the system interacts with other implanted devices such as pacemakers. Patient injury or device failure may be caused by other medical treatments such as electrocautery, defibrillation/cardioversion, therapeutic ultrasound, or radiofrequency (RF)/microwave ablation. Patient activities may cause shocking or jolting sensations.
The Enterra II System is MR Conditional. This means that patients with the Enterra II System can safely have MRI examinations of some body parts under certain conditions. Consult your doctor to determine if you are eligible for MRI examination.
Risks: Potential risks include infection, pain at the surgery site, allergic or immune system response, lead and bowel twist together, device wearing through the skin, bruising, bleeding, loss of therapeutic effect, jolting, shocking, burning sensation, gastrointestinal or stomach issues, loss of therapy due to component failure or battery wear out, or perforated stomach which may cause life-threatening blockage or infections that require immediate medical attention including surgery. Risks can be minimized by avoiding activities such as sudden, excessive, or repetitive bending, twisting, bouncing, or stretching.
Humanitarian Device: Authorized by Federal law for the intended use described above. The effectiveness of this device has not been demonstrated.
Always discuss potential risks and benefits of the device with your physician.
For further information, please contact Enterra Medical at firstname.lastname@example.org.
Enterra® is a registered trademark of Enterra Medical, Inc. in the US, EU, and other regions.
This press release contains “forward-looking statements” concerning the development of Enterra Medical’s products, the benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Enterra Medical undertakes no obligation to update any forward-looking statements for any reason.
Jenny Rogers, VP Marketing
MKT-D-0003, Rev K
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.
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?