The U.S. Centers for Medicare & Medicaid Services has proposed the launch of a clinical trial testing out LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation therapy system intended to treat Treatment-Resistant Depression as it looks to adjust its National Coverage Determination for the device.
The London-based medtech company said that with CMS’ proposal to change the NCD for VNS Therapy, the agency could initiate coverage through its Coverage with Evidence Development as part of a CMS-approved study.
The proposed study would be a double-blinded, randomized, placebo-controlled trial with a follow-up duration of one year with the possibility of an extension into a prospective longitudinal study, according to CMS.
LivaNova said that they “intend to commence a clinical study that meets those requirements” once the NCD decision has been finalized, which is set to take place on or before February 17 of next year.
“LivaNova remains committed to providing additional treatment options for patients with depression and finds the Proposed Decision Memo from CMS to be a positive step toward increased access to important therapies for these patients. Over the last decade, a significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with chronic or recurrent depression,” LivaNova wrote in a press release.
Late last month, LivaNova’s shares came under pressure after the medical device maker put up sales and earnings numbers that fell shy of expectations as it swung to third-quarter red ink, despite its boosted top-line outlook for 2018.