HeartMate 3 Receives FDA Approval - Jewish Hospital Was First in Kentucky to Implant the Heart System - Archived

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HeartMate 3 Receives FDA Approval - Jewish Hospital Was First in Kentucky
to Implant the Heart System

The LVAD technology offers significant advancements, including a pump that is designed to reduce complications while improving survival and quality of life for patients with advanced heart failure

Louisville, Ky. (November 13, 2017) – Jewish Hospital, part of KentuckyOne Health, was the first facility in Kentucky to implant the HeartMate 3™ LVAD, which was just approved by the FDA for short-term use. Mark S. Slaughter, MD, professor and chair, department of Cardiovascular and Thoracic Surgery, University of Louisville and Jewish Hospital, and his team played an important role in the clinical trial.

This will continue to be an option to choose by physicians managing advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge to myocardial recovery). The system also provides patients living with their device new benefits that embody the evolution of left ventricular assist device (LVAD) therapy, such as improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.

More than 5.7 million people in the United States suffer from heart failure and approximately 915,000 new patients are diagnosed with the disease each year. For advanced heart failure patients who can no longer rely on earlier stage treatment options, an LVAD can help their weakened heart pump blood through the body and provide crucial support as patients await further treatment, including heart transplants.

With each new generation of heart pumps, we continue to see improvements in reducing adverse events and better durability and reliability of the pump.

“The HeartMate 3 is the first completely magnetically levitated continuous flow heart pump. It has no touching parts so there can be no ‘wear and tear’ on the device, thus improving durability,” said Dr. Slaughter. “Also, it is more compatible with blood causing less hemolysis or trauma to the blood.”

Abbott designed the HeartMate 3 system to take LVAD therapy further and provide physicians new benefits for their patients. In developing the HeartMate 3 system, Abbott reduced the system's size while reimagining how blood passes through an LVAD. The HeartMate 3 system deploys Full MagLev technology to reduce trauma to the blood passing through the pump while optimizing blood flow. Improved blood flow can help minimize complications – such as pump thrombosis – that can be associated with LVAD therapy, ultimately improving the patient's quality of life.

Jewish Hospital is home to a number of firsts in heart care dating back to 1965, when Western Kentucky’s first adult open heart surgery was performed there. The hospital is the site of the region’s first dedicated heart and lung center. To-date, Jewish Hospital is home to nearly 40 “firsts” in heart care, including:
•    Kentucky’s first transcatheter aortic-valve replacement (TAVR), a medical breakthrough  giving hope to patients in need of a valve replacement who are not well enough to undergo open heart surgery
•    Nation’s first female patient implanted with the C-Pulse Heart Assist System
•    World’s first AbioCor totally implantable hearts  
•    And the world’s first phase-one FDA-approved clinical trial using “c-kit-positive” adult cardiac stem cells to treat heart disease

For patients who are not candidates for heart transplants or who will live with their device long-term, Abbott continues to offer HeartMate II™, the world's most widely used LVAD, which is indicated for long-term or "destination therapy."

The HeartMate 3 system is the only commercially-approved continuous flow implantable left ventricular assist system to utilize Full MagLev™ (fully magnetically-levitated) Flow technology, which allows the device's rotor to be "suspended" by magnetic forces—rather than bearings—with the goal of being able to more gently pass the blood cells through the pump. The magnets keep the rotor in place by calibrating tens of thousands of times per second to ensure it stays suspended and centered within the pump, no matter the speed settings used by a physician. This ensures the pump is performing effectively while continuing to deliver the best patient therapy possible.

The HeartMate 3 system also uses the industry's widest pump pathway, designed so the blood cells are not damaged when passing through. The HeartMate 3 system includes the LVAD pump as well as the rest of the components that are crucial to making this technology work—an external, wearable controller, driveline and battery system that powers the pump. The HeartMate 3 System was CE Mark approved in Europe for both short-term and long-term support in October 2015.

U.S. approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. In that study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83 percent increase in their walk distance and a 68 percent improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86 percent survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.

For more information about heart care at Jewish Hospital, visit www.kentuckyonehealth.org/louisville-heart-care.

About Jewish Hospital
Jewish Hospital, part of KentuckyOne Health, is an internationally renowned, high-tech tertiary referral center, developing leading-edge advancements in hand and microsurgery, heart and lung care, orthopedics and sports medicine, neuroscience, organ transplantation and outpatient care. The hospital is the site of the world’s first successful hand transplant and AbioCor® implantable replacement heart procedures, in addition to the first trial of cardiac stem cells in chronic heart failure. Jewish Hospital continues to be recognized for its specialized heart care procedures, including the implant of ventricular assist devices (VAD) and transcatheter aortic valve replacement (TAVR). The Jewish Hospital Trager Transplant Center is in a select group that performs heart, lung, liver, kidney and pancreas transplantation and was part of the first international paired kidney exchange program. Services are also provided throughout the community at multiple freestanding outpatient care centers.

About KentuckyOne Health
KentuckyOne Health, one of the largest and most comprehensive health systems in the Commonwealth, includes hospitals, physician groups, clinics, primary care centers, specialty institutes and home health agencies in Kentucky and southern Indiana. KentuckyOne Health is dedicated to bringing wellness, healing and hope to all, including the underserved.
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