The Recover study is designed to determine whether active VNS therapy is a superior option compared to a no-stimulation control in producing a reduction in baseline symptom severity of depression.
LivaNova plans to enroll up to 500 unipolar and up to 500 bipolar patients across as many as 100 sites in the U.S. for the double-blinded, randomized, placebo-controlled study. Recover has a follow-up duration slated for one year and a possibility to extend to a prospective longitudinal study.
The VNS therapy system received CE Mark approval in 2001 and FDA approval in 2005 for the adjunctive long-term treatment of chronic or recurrent depression in patients 18 or older who have not had an adequate response to four or more antidepressant treatments. Earlier this month, the FDA approved The London-based company’s Symmetry VNS therapy system. On September 6, Medicare approved the Recover study.
“Through the Recover study, we have the ability to help patients with TRD across the United States gain access to a potentially meaningful treatment option to improve depressive symptoms and their quality of life,” St. Louis University’s Dr. Azfar Malik, who enrolled the first patient, said in prepared remarks. “I have had positive results treating depressed patients with VNS therapy in the past. I look forward to gaining a greater understanding of TRD and evaluating how patients respond to VNS therapy as an adjunctive treatment during this study.”
“With the enrollment of the first patient in Recover, we are on a pathway to better address treatment for depression, which is the leading cause of disability in the U.S.,” added LivaNova CEO Damien McDonald. “We are committed to this journey and to the patients who seek and deserve better forms of treatment.”
“Symmetry is the first and only FDA-approved implantable device specifically designed for depression that is difficult to treat,” said LivaNova vice president of depression Jonathan Walker. “We are pleased that the latest model of our VNS therapy system, Symmetry, is now available as an option for patients.”
Shares of LIVN were up 0.5% at $74.25 per share in late-morning trading today.