Posted October 16, 2018
First FDA-cleared non-invasive medical device for OCD, now available in the Bay Area
SAN FRANCISCO – October 16, 2018 – Mindful Health Solutions, the Bay Area’s largest provider of mental health services for treatment-resistant patients and a leader in education on TMS for mental health disorders, announced today that the company is now offering BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) for the treatment of Obsessive-Compulsive Disorder (OCD). Deep TMS was recently cleared by the U.S. Food and Drug Administration (FDA) for the treatment of OCD, becoming the first FDA-cleared medical device for treatment of OCD and first TMS system to address multiple brain disorders.
“We are excited to provide this groundbreaking and life-changing treatment to patients in the Bay Area,” said Dr. Ryan Vidrine, lead physician for the OCD program at Mindful Health Solutions. “This is a big breakthrough that can help the many OCD patients who have not fully benefited from medications and therapies.”
According to the American Psychiatric Association, about 2.2 million Americans have OCD. Today, roughly half of patients with OCD do not respond to conventional treatments such as antidepressants and Exposure Response Prevention Therapy (ERP Therapy). BrainsWay’s patented breakthrough treatment, using the company’s proprietary Deep TMS technology introduces a new era of treatment to help those suffering from OCD.
The Deep TMS helmet for OCD sends magnetic fields into the deep structures of the anterior cingulate cortex, the region of the brain known to be involved in OCD. Deep TMS has many advantages over other treatment options. It is an outpatient procedure, does not require hospitalization or anesthesia, is generally well-tolerated, and has minimal systemic side effects.
With eight locations across Northern California, Mindful Health Solutions provides extensive mental health services, with a team of clinicians and staff focused on the research and treatment of mental health disorders. Mindful Health Solutions specializes in offering TMS to patients with treatment-resistant depression and can now expand services to include patients suffering with OCD.
Mindful Health Solutions also leads TMS Health Education, a continuing education initiative for doctors to learn the benefits of TMS. One course within the initiative, Hands-On TMS Symposium, provides practical and current information to physicians and health professionals interested in the clinical use of TMS. The program is led by Dr. Richard Bermudes and Dr. Karl Lanocha, two of the leading experts in brain stimulation technology.
BrainsWay’s OCD therapy clearance is based on excellent results from a multicenter, randomized controlled study. 38% of patients achieved a response to the treatment, corresponding to a greater than 30% reduction in OCD symptoms (as measured by the Y-BOCS scale), and 54% achieved a partial response, corresponding to a greater than 20% reduction in OCD symptoms.
About Mindful Health Solutions
Mindful Health Solutions was founded in 2007 by Dr. Richard Bermudes, who sought to develop a group practice that provided innovative, patient-centric care with the focus of an academic research institution, continually incorporated new and groundbreaking treatment methods while educating the community. Since then, Mindful Health Solutions has opened eight clinics across Northern California, with locations in Burlingame, Oakland, San Francisco, Walnut Creek, El Dorado Hills, Roseville, and Sacramento.
BrainsWay Ltd./ BrainsWay USA is a leader in noninvasive treatments for brain disorders utilizing Deep Transcranial Magnetic Stimulation (Deep TMS). Our unique patented technology was developed in collaboration with the National Institute of Health (NIH) and is FDA and CE cleared to treat patients with depression and obsessive-compulsive disorder who are not currently responding to medication. The treatment has been enthusiastically supported by many academic communities and is widely covered by most insurance payers. For more information, please visit www.brainsway.com.
BrainsWay Deep TMS is indicated by the FDA for the treatment of depressive episode in adults suffering from Major Depressive Disorder, who failed to achieve satisfactory improvements from previous antidepressant medication treatment in the current episode. FDA 510(k) No. K122288
Brainsway Deep TMS is indicated by the FDA as an intended adjunct treatment for adult patients suffering from Obsessive-Compulsive Disorder (OCD). FDA De Novo No. DEN170078.
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