Abbott Implements Corrective Action For Heartmate 3 Heart Pump

Abbott previously communicated safety alert related to potential outflow graft twisting to physicians on April 5, 2018.

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.


No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3.

Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide (incidence rate of 0.72%), including reports of low blood flow, clotting (known as thrombus), and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.

In patients living with an LVAD, low flow alarms can often indicate unrelated conditions such as hypertension. For patients who experience a persistent low flow alarm after such causes have been ruled out, a computed tomography (CT) scan can help detect any possible outflow graft twisting. In addition, physicians managing patients that exhibit a persistent low flow alarm should determine patient care recommendations based on each unique clinical case.

Abbott has also alerted implanting physicians that as stated in the device's instructions for use (IFU), properly hand tightening the screw ring at the time of implant may reduce the chance of outflow graft twisting. Abbott has proactively contacted all physicians who treat patients impacted by this safety alert and will continue to assess current reports of outflow graft twisting to further provide physicians with patient care recommendations.

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.