Abbott Reentry in DBS Depression a Boost for Market

by James Cavuoto, editor

July 2022 issue

The neuromodulation market for treating psychiatric disorders received a significant boost earlier this month with the news that Abbott is re-entering the market for treating major depression using deep brain stimulation. St. Jude Medical, which Abbott acquired in 2017, departed the psychiatric disorders market after the FDA halted the firm’s BROADEN trial of DBS of Cg25 in 2012 because of a failed futility analysis.

In 2019, one of the pioneers of this work, Helen Mayberg at the Icahn School of Medicine at Mount Sinai, published a paper in the American Journal of Psychiatry that showed positive long-term data—four- to eight years—from subcallosal cingulate DBS for treatment resistant depression, possibly an indication that the BROADEN trial was halted prematurely. Two years earlier, Abbott had published 24-month data from the trial in the journal The Lancet: Psychiatry that showed better results than the initial six and 12-month data.

Earlier this month, Abbott announced that the FDA has granted breakthrough device designation to investigate the use of its DBS system in treatment-resistant depression, an indication that the company has resumed its commercialization efforts in the depression market. Abbott is working with the FDA to develop a plan for evaluating the device’s safety and effectiveness for this purpose. The company pointed out that one of the added benefits of Abbott DBS systems is that they can be used with NeuroSphere Virtual Clinic, a connected care technology that allows people to communicate with and receive care and therapy adjustments from their doctors remotely and from the comfort of their own home.

For patients who suffer from TRD, a condition that costs the U.S. approximately $44 billion a year in healthcare, unemployment and lost productivity, DBS has the potential to offer meaningful improvement of depressive symptoms. Currently, physicians have access to a range of treatments for MDD, including antidepressant medications and device therapies. Despite this, up to a third of individuals diagnosed with MDD—approximately 2.8 million Americans each year—do not respond even after trying four different antidepressant regimen approaches resulting in TRD or difficult-to-treat depression. With each failed treatment, the chance of experiencing a decrease in symptoms drops. By the fourth failed treatment, as many as 83 percent of patients will relapse.

“Breakthrough product development always requires bold thinking and collaboration, and Abbott is fully committed to the journey of providing people with new therapeutic options for their treatment-resistant depression,” said Pedro Malha, vice president, neuromodulation, Abbott.

Boston Scientific is also known to be pursuing the DBS market for MDD. At the International Neuromodulation Society meeting in Barcelona in May, Thomas Schlaepfer from the University Hospital Freiburg in Germany described his team’s work in collaboration with Boston Scientific with DBS of the medial forebrain bundle, The FORESEE III trial showed positive results in 32 patients; final data will be presented next year.

Meanwhile, other vendors of neuromodulation therapies to treat psychiatric disorders reported progress in their commercialization efforts. Earlier this month, Neuronetics announced FDA clearance for a new indication for its NeuroStar transcranial magnetic stimulation system to treat anxiety symptoms for adult patients who suffer from MDD.

“Today, we celebrate a big win for NeuroStar patients and providers,” said Keith Sullivan, president and CEO of Neuronetics. “Many people suffering from MDD also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide.”

The company previously announced a series of healthcare policy updates that increase patient access to NeuroStar. First Coast and Novitas Medicare Administrative Contractors have proposed policy updates to local coverage determination that would reduce the number of prior medication failures for TMS eligibility from four down to one for people suffering from MDD. An additional proposed change would remove the requirement for a previous psychotherapy trial.

Another TMS vendor, Israel-based BrainsWay Ltd., announced the Israeli Ministry of Health has approved coverage applicable of its Deep TMS system for the treatment of depression. The inclusion of the treatment within Israel’s health basket of essential medical services means that the country’s health funds must now make the treatment available to qualifying patients free of charge. Qualifying patients include adults over the age of 21 with depression who have either not responded to two prior antidepressants, or who are intolerant to other treatment alternatives. Coverage may be provided for up to 40 treatment sessions, which are to be administered in hospitals.

“We are excited to have achieved this significant milestone in accessing treatment with our Deep TMS system, which is renowned as an Israeli innovation. This is good news for many Israeli patients who have been waiting for greater access to our unique technology,” said Christopher von Jako, president and CEO of BrainsWay. Since BrainsWay’s inception, the company has always maintained an important presence in Israel, with key management, research, development, and operational roles, as well as leading physicians, based in Israel. “Facilitating insurance coverage through Israel’s health system is a key component of our growth strategy. We remain committed to further expanding insurance coverage in Israel and around the world in order to expand access to our groundbreaking treatment for the benefit of patients across the globe.”


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