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SOURCE Thoratec Corporation
Implanted at University of Michigan Cardiovascular Center, Joe Ann's Heart has been Supported with the HeartMate II® Left Ventricular Assist Device since July 2005
PLEASANTON, Calif. and ANN ARBOR, Mich., March 19, 2013 /PRNewswire/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support (MCS) therapies to save, support and restore failing hearts, and the University of Michigan Cardiovascular Center, a leader in cardiac care, today announced a major milestone in the treatment of heart failure. Joe Ann Bivins, 68, of Detroit, Michigan, has been supported for the longest reported period of time on a single heart assist device. The device, the HeartMate II Left Ventricular Assist Device (LVAD), supplements her heart's pumping function and allows her to live her life virtually free from the symptoms of heart failure.
Joe Ann was implanted in July 2005 at the University of Michigan, early in the HeartMate II pivotal clinical trial. Now at nearly eight years of support, Joe Ann exemplifies the life-improving benefits of LVAD therapy for heart failure.
According to the American Heart Association, there are approximately 5.8 million individuals living with chronic heart failure in the United States, many of whom may face a similar decision to the one made by Joe Ann almost eight years ago. Joe Ann's heart had become too weak to adequately pump blood, leaving her tired and weak. Francis D. Pagani, M.D., Ph.D., Surgical Director of the Adult Heart Transplant Program and Director of the Center for Circulatory Support, told Joe Ann that her condition could improve with the help of an LVAD, the HeartMate II. Joe Ann elected to have the surgery, and she now describes her life as being as close to normal as she could imagine. Today, she sings with her church choir, attends bible study, heads the church usher board, and stays active and social with her sisters and son by her side. She also speaks with patients who are considering LVAD treatment for their heart failure condition, encouraging them to regain the life they once knew as well.
The fact that Joe Ann is now the longest surviving patient with a heart assist device came as a surprise to her. Said Bivins: "I didn't even realize my journey was so significant. I was too busy living my life to the fullest. It's certainly something special to be given a second chance, and it's even more of a blessing to know that my story can give others with heart failure the same hope I have every day, which is to continue to be saved by my wonderful doctors and nurses, and my HeartMate II."
Joe Ann's experience has been validated by clinical studies, in which HeartMate II has demonstrated significant improvements in quality of life as well as reductions in symptoms of heart failure. Joe Ann hopes her story will encourage people suffering from heart failure to know they have a choice and a path to a better life.
"Joe Ann is truly a star patient, and her ability to continue to thrive is a testament to how well LVAD therapy works for patients in heart failure to alleviate their heart failure symptoms and give them back an improved quality of life," said Pagani. "We encourage people who are battling heart failure to speak with their doctors about treatment with an LVAD. Joe Ann is living proof that this therapy can turn lives around."
HeartMate II is a heart pump called an LVAD, which helps the left side of the heart to circulate blood to the rest of the body. It is implanted alongside the heart and supplements the heart's pumping function. The HeartMate II system also includes accessories that are worn outside the body, including a controller and batteries that last more than ten hours, allowing patients to be active.
HeartMate II is the most widely used and extensively studied LVAD in the world. Featuring innovative design elements, including proprietary textured surfaces, blood immersed ruby bearings and open flow paths, HeartMate II has proven to be a highly durable device capable of long-term circulatory support. In clinical testing, over 80 percent of HeartMate II recipients became virtually free of heart failure symptoms shortly after implant and sustained those improvements for the full two-year follow-up period. Moreover, controlled clinical trials as well as large-scale commercial experience have demonstrated significant improvement in patients' functional capacity, with 94 percent of HeartMate II recipients able to perform the 6-minute walk test after six months of support. [3,4] Overall, many patients report returning to active living, with meaningful improvements in their quality of life. To date, over 13,000 patients have been implanted with HeartMate II, including approximately 6,000 currently on support. HeartMate II is the only continuous-flow LVAD approved by the FDA for both Bridge-to-Transplantation and Destination Therapy, or permanent support.
Thoratec Corporation and the University of Michigan Cardiovascular Center encourage heart failure sufferers and their loved ones to learn more about the choices for treatment and become involved in the treatment plan. The first step is to speak with a doctor and find out more information about treating heart failure.
Thoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures and distributes the CentriMag and PediMag / PediVAS product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
About University of Michigan Health Services
The University of Michigan's commitment to providing advanced cardiovascular care led to the creation of the University of Michigan Cardiovascular Center. The 5-level facility opened in 2007 and unites the U-M Health System's cardiovascular services. The Center includes operating rooms, clinics, inpatient beds and indoor and outdoor healing gardens. The U-M is the top ranked heart and heart surgery program among Michigan hospitals. To learn more visit www.uofmhealth.org/heart.
Individual experiences, symptoms, situations, and circumstances may vary. Please consult your physician or qualified health provider regarding your condition and appropriate medical treatment.
Indications: The HeartMate II LVAS (Left Ventricular Assist System) is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II LVAS is intended for use both inside and outside the hospital.
Contra-Indications: The HeartMate II LVAS is contraindicated in patients who cannot tolerate or are allergic to anticoagulation therapy.
Common Side Effects: Death, bleeding, cardiac arrhythmia, infection, respiratory failure, device malfunction, sepsis, right heart failure, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral or device-related thromboembolic event, hemolysis, hepatic dysfunction, myocardial infarction.
Many of the preceding paragraphs contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "views," "expects," "plans," "projects," "hopes," "could," "will," "intends," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, the development of new products and new markets, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of FDA regulatory requirements, and the effects of competition. Forward-looking statements contained in this press release should be considered in light these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
 Reichenbach SH, Masterson KB, Butler KC, Farrar DJ. Negligible bearing wear in explanted HeartMate II LV ADs following clinical support for up to 4 years. Paper presented at: Proceedings of the Annual Meeting of the International Society of Rotary Blood Pumps; October 14-15, 2010; Berlin, Germany.
 Park SJ, Milano CA, Tatooles AJ, et al; for the HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5(2):241-248.
 John, Naka, Smedira, et al. Ann Thorac Surg 2011;92:1406-13.
 Rogers, Aaronson, Boyle, et al. JACC 2010;55:1826-34.
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