Enterra Medical, Inc.
Therese (Tess) Radtke, M.S., RAC has a diverse background in regulatory affairs, including roles at companies like Enterra Medical, Stryker, Boston Scientific, Synovis Surgical Innovations, Baxter International Inc., and Upsher-Smith Laboratories. With a Master's degree in Regulatory Affairs from St. Cloud State University and a Bachelor's degree in Biochemistry and Molecular Biology from the University of Minnesota Duluth, Therese brings a wealth of knowledge and experience to their current position as Senior Principal Regulatory Affairs Specialist at Enterra Medical, Inc.
Enterra Medical, Inc.
Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.* In order to increase investment and focus on the therapy, Enterra Medical was formed in 2022 and has begun the process to assume ongoing responsibility of Enterra Therapy from Medtronic. This process began with commercial responsibilities and will continue to expand to other aspects of the business. Medtronic remains a strong operational partner in this new management model and will continue to handle customer and patient support until Enterra Medical is fully equipped to assume those functions. Gastroparesis is a condition in which food moves through the stomach too slowly, causing chronic nausea and vomiting. Enterra Therapy, approved by the FDA under a Humanitarian Device Exemption in 2000, may be a surgical option for certain people who are unable to control chronic symptoms of gastroparesis.* It is the first and only implantable therapy for Gastric Electrical Stimulation, and over 15,000 people have received Enterra Therapy to help resume everyday activities. Consult with a doctor to see if Enterra Therapy may be an option for you. *Humanitarian Device. Enterra Therapy is 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. Visit www.enterramedical.com/important-safety-information/ for important safety information.