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Abbott: For Some Patients, Deep Brain Stimulation May Address Chronic Depression

A new dataset published in The Lancet: Psychiatry highlights the largest prospective study in DBS for chronic, treatment-resistant depression.

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New data published in The Lancet: Psychiatry has found that deep brain stimulation (DBS) may offer some patients an option for managing their chronic, treatment-resistant depression. The data, which stems from the Abbott-sponsored BROADEN Study, also provides safety and feasibility results of DBS therapy as a treatment for these patients and the authors concluded that after 24 months of stimulation, nearly half of all DBS patients responded to the therapy. Of these patients, 26 percent of patients experienced remission of their depression; a remission rate that steadily grew over time.

While the BROADEN study initially found no statistically significant difference in efficacy between the stimulation group and the control group after six and 12 months, after the initial 12-month study, 77 of 90 participants entered into a four-year follow-up study. Within that follow-up study, the authors found that patients receiving DBS therapy saw response and remission rates of 29 percent and 14 percent at 12 months, 53 percent and 18 percent at 18 months, and 49 percent and 26 percent at 24 months, respectively. Currently, DBS is not currently indicated for depression and Abbott is FDA-approved only to offer DBS for essential tremor and Parkinson's disease.

"Innovation within the field of neuroscience takes time and is filled with opportunities to learn, adapt and learn again. This study is a strong example of how our therapies can contribute to the innovation taking place within the broad field of neuroscience," said Allen Burton, M.D. medical director within Abbott's Neuromodulation Division. "We applaud the researchers who led this study and look forward to future advancements to support the care of people suffering from chronic, treatment-resistant depression."

Depression affects more than 21 million adults in the U.S., according to the National Institute of Mental Health. Nearly 4 million people live with severe depression that doesn't respond to traditional treatment or multiple treatment attempts.

"While I am disappointed by the initial results, I'm encouraged by the long-term outcomes seen in this trial, which are consistent with previous and ongoing experience with DBS outside of this clinical trial," said Helen Mayberg, M.D., professor of psychiatry, neurology and radiology at Emory University in Atlanta, Georgia. "There are refinements to optimize DBS delivery that may prove useful to understand these findings and move the therapy forward. For example, we now know that implantation method and directionality matter for optimal patient outcomes. We look forward to seeing what new innovations, such as use of advanced imaging to guide the implantation and use of directional leads, can do in the future."

Assessing a New Approach to Depression Treatment

Clinical research has often implicated activity within an area of the brain known as "Brodmann Area 25" as compounding treatment-resistant depression. Researchers have pointed to DBS as a new option for patients because modern systems can precisely target stimulation to this area and deliver remission to patients who had not responded to prior therapy attempts.

Abbott originally launched the randomized controlled BROADEN study in 2008 to assess DBS therapy in patients with chronic, treatment-resistant depression. The study, which utilized the investigational Abbott Libra™ deep brain stimulation system, built upon a pilot study that showed meaningful reductions in depression in patients receiving DBS therapy and on the groundbreaking work of Dr. Mayberg and colleagues that supported the application of DBS therapy in patients with treatment-resistant depression. When the BROADEN study was discontinued, patients were then monitored in a follow-up study.

The BROADEN study enrolled 128 patients and implanted 90 between the ages of 21 and 70 years of age at 13 centers who had been diagnosed with major depressive disorder. Patients must have tried at least four treatments for their depression without a meaningful treatment response. Patients should talk to their physician about the benefits and risks of any DBS therapy option and should consider this data as investigational in nature and not indicative.

The Conversation

NEW COVERAGE DECISION EXTENDS ABBOTT'S INNOVATIVE PAIN THERAPY OPTION TO 22 MILLION AMERICANS LIVING WITH CHRONIC PAIN

Abbott is the only company in the world with FDA and CE Mark approval to offer dorsal root ganglion (DRG) neurostimulation therapy to treat complex nerve pain conditions.

Originally Published by Abbott.

Abbott announced a new national coverage determination for the company's dorsal root ganglion (DRG) neurostimulation pain therapy through Aetna®, a leading health benefits company in the United States. With this coverage decision, Aetna will provide more than 22 million medical plan members with access to Abbott's DRG therapy for people with chronic pain.

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Abbott: Expediting Blood Testing With i-Stat

The portable, handheld i-STAT Alinity delivers quick blood test results anywhere you are.

Originally Published by Abbott.

Every day, countless blood samples are tested all around the world for one purpose: to help diagnose and treat medical conditions. From the couple eagerly awaiting the results of a pregnancy blood test to a worried cancer patient hoping for more answers, diagnostic blood tests give vital insight into what's happening underneath the skin.

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Abbott: Freestyle Libre 14 Day, Now FDA Approved

Abbott's flash glucose monitor now FDA-approved for two weeks of use in U.S. between sensor changes.

Originally Published by Abbott.

The U.S. Food and Drug Administration has approved FreeStyle Libre 14 day— Abbott's revolutionary continuous glucose monitoring system. In the U.S., you can wear the sensor up to 14 days with high accuracy.

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​Abbott Announces Freedom 2 Save Program For Employees To Address Student Debt

Two-thirds of millennials aren't saving for retirement; benefit means student debt won't prevent retirement savings.

Originally Published by Abbott.

Historic levels of student debt have forced many people to choose between saving for their futures and paying off school loans. Abbott announced a groundbreaking program that addresses the student debt crisis and changes that math.

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Abbott: Connected Devices Turn Data Into Better Health

Abbott's Robert Ford Joins a Panel Discussing the Potential for Connected Medical Devices to Improve Patient Care and Drive Better Outcomes.

Originally Published by Abbott.

Today's medical devices are creating terabytes of information that gives patients, doctors and health providers real-time insight into someone's vital statistics, heart health and even bloodwork.

But can all this new information really make someone healthier?

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Abbott Introduces the Afinion™ 2 Analyzer Rapid Test System for Diabetes Management

State-of-the-art multi-assay test system helps people with diabetes get the HbA1c results they need within three minutes — allowing more time for consultation and care during a single healthcare visit.

Originally Published by Abbott.

Abbott announced the launch of its Afinion™ 2 analyzer in the U.S., the newest generation of the Afinion test system. The Afinion 2 builds on Abbott's heritage in diabetes care by empowering patients with information about their health that they can discuss with their providers during a single visit.

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Abbott's Xience Sierra Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan.

Originally Published by Abbott.

Abbott announced that Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent. XIENCE Sierra improves upon previous versions of XIENCE with an enhanced stent design, a new delivery system, and unique sizes to help doctors treat challenging cases.

XIENCE Sierra was designed to help doctors more easily treat people with difficult-to-treat blockages that involve multiple or totally blocked arteries or complications such as diabetes. Complex cases are increasingly prevalent as people with coronary artery disease are living longer.

"Extensive clinical data and 10 years of real-world experience with the XIENCE family of stents provide doctors with confidence that they are treating their patients with one of the safest stents available," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "National reimbursement of XIENCE Sierra will provide people in Japan with greater access to this life-changing technology that can help them live their best lives."

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan. National reimbursement in Japan will enable doctors to treat more patients with XIENCE Sierra through the country's health insurance plans. XIENCE Sierra was approved in Japan on April 4, 2018, received CE Mark in Europe late last year, and is under review with the U.S. Food and Drug Administration.

XIENCE has been studied in over 100 clinical trials and in 10 years of global real-world experience. Its safety profile is unprecedented with consistent low rates of stent thrombosis, even in complex cases. More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.