HeartMate II ® Left Ventricular Assist Device (LVAD)
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FO R USE AN YTIM E CO N TACT: Susan Benton Russell Phone: 310.697.3488 susan@bentoncommunications.com HeartM ate II ® Left Ventricular Assist Device (LVAD) Fact Sheet Product: The Thoratec HeartMate II Left Ventricular Assist Device (LVAD) is a mechanical circulatory support (MCS) device intended for a broad range of advanced-stage heart failure patients. HeartMate II is designed to restore blood flow, improve survival, functional status, and quality of life. Current Indications: Based on the impressive clinical outcomes of the landmark HeartMate II clinical trial initiated in 2003, the HeartMate II received FDA approval for Bridge-toTransplantation (BTT) in April 2008. On January 20, 2010, FDA approval was received for Destination Therapy (DT), or long-term support, for those who do not qualify for heart transplantation due to age or other circumstances. The HeartMate II incorporates many features specifically intended to minimize the risk of complications and improve device durability while enhancing patient outcomes. • Survival. Major clinical studies have shown HeartMate II to provide longterm survival that is up to six times greater than previously reported outcomes with medical therapy alone, and more than two times greater than the previous DT-approved device. • Quality of Life. The HeartMate II is an implantable device that facilitates freedom of movement, routine daily activities, travel and even some sports like golf - leading to an improved quality of life for patients. • Home Discharge. HeartMate II patients can be discharged from the hospital, providing significant psychological and social benefits to the patient as well as cost savings to the patient and hospital alike. • Low Incidence of Thromboembolic (TE) Complications - Stroke. The blood flow path has been optimized to ensure thorough washing of surfaces and eliminate stagnation. And blood-contacting surfaces are designed to avoid blood damage. As a result, the HeartMate II is exceptionally durable, dependable and thromboresistant. • Simplicity/Ease-of-Use. The simple design - with one moving part contributes substantially to reliable operation. • Durability. The device was designed for long-term support.

Thoratec Press Kit: HeartMate II Fact Sheet – page 2 of 3 Lightweight. HeartMate II measures approximately three inches in length and weighs approximately 10 ounces. Active Lifestyle. In May 2013, the FDA approved Thoratec’s nextgeneration HeartMate II Pocket Controller™, which lighter and more compact than previous LVAD system controllers in order to support the active lifestyle that patients with HeartMate II are leading. The HeartMate II is implanted alongside a patient’s native heart and designed to take over the pumping ability of the weakened heart’s left ventricle, which is...

Thoratec Press Kit: HeartMate II Fact Sheet – page 3 of 3 DEVICE HeartMate II LVAS REGION • United States STATUS • Bridge-to-Transplantation – Received FDA approval in April 2008. • Destination Therapy – Received FDA approval in January 2010. • Authorized to bear the Conformité Européenne (CE) Mark in November 2005. ###