FDA Approves Enterra II System for MR Conditional Use

Enterra Medical Inc.’s Enterra II System has been granted MR Conditional approval from the U.S. 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. “This is a significant milestone in our journey to increase innovation in this therapeutic area and to help people living with gastroparesis find relief,” Enterra Medical CEO Peter Sommerness said.
 
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.

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. The Enterra II Neurostimulator model 37800 is 2.4 inches (60 mm) long, 2.2 inches (55 mm) high, and 0.5 inches (11.4 mm) thick. It weighs 1.6 ounces (45 grams).
 
“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,” Enterra Medical Vice President/Medical Director Kenneth Koch, M.D., stated. “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.”
 
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. The company is based in St. Louis Park, Minn.