PLEASANTON, Calif., Nov. 3, 2011 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced today the enrollment of the first patient into the ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) study. The patient was enrolled at INTEGRIS Baptist Medical Center in Oklahoma City.
ROADMAP is a post-market study of the HeartMate II® Left Ventricular Assist System (LVAS) as a Destination Therapy device. The study will involve ambulatory advanced heart failure patients who are not yet dependent on intravenous inotropic support and are typically categorized as INTERMACS profiles 4-6, within the existing FDA-approved indication for Destination Therapy. The primary objective of the prospective, multi-center, non-randomized, controlled, observational study is to evaluate and compare the effectiveness of HeartMate II support versus Optimal Medical Management (OMM).
"Our team is excited to embark on the ROADMAP study," said Doug Horstmanshof, M.D., Program Director of the Heart Failure Institute at INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma and lead investigator. "This is an important area of investigation, in that we are evaluating a large portion of the eligible Destination Therapy patient population in which the utilization of mechanical circulatory support (MCS) therapy to date has been limited. By generating targeted data on the efficacy of the HeartMate II LVAD as compared to medical management in these patients, ROADMAP should help us better inform patients, referring cardiologists, and implant centers about optimal therapy for individuals with a less advanced stage of heart failure than has been studied in previous chronic MCS trials."
Subjects will be enrolled in one of two cohorts: OMM or LVAD. Clinical investigators and the patients will decide which cohort a patient will enter based on the center's standard of care and patient acceptance of therapy options. Baseline risk assessment profiles will allow for stratification of expected risk and severity of illness. The study will include 200 patients at up to 50 sites, including experienced HeartMate II implant centers as well as community centers that care for a large volume of advanced heart failure patients.
"The study design will provide the opportunity to secure additional data needed to improve patient selection. It will also allow for evaluation of therapy pathways from a range of centers with different LVAD implantation strategies, as well as a comparison of the results from early versus delayed implantation," said David Farrar, Ph.D., Vice President, Research and Scientific Affairs.
Patients will be followed for two years, and the primary endpoint will be a composite of survival and functional improvement, as measured by the six-minute walk test, at one year. Secondary endpoints include actuarial survival, quality of life, pump replacement, adverse events and rehospitalizations.
"We believe there is a substantial unmet need for treatment options to improve functional status and quality of life in this advanced heart failure patient population, prior to the need for continuous inotropic support or the development of irreversible end organ dysfunction," said Gary Burbach, President and Chief Executive Officer of Thoratec. "We are proud to be associated with many of the leaders in this field who will be spearheading this research. We look forward to obtaining new data to support MCS therapy and to better understanding the factors related to patient and physician decisions for HeartMate II therapy versus continuing OMM."
For more information regarding the ROADMAP study, visit http://clinicaltrials.gov ID# NCT01452802.
About HeartMate II
The HeartMate II is intended for a broad range of advanced heart failure patients and is the only continuous-flow left ventricular assist device (LVAD) approved by the FDA for both Bridge to Transplantation and Destination Therapy. The device is designed to provide long-term cardiac support, pumping up to 10 liters of blood per minute for full support of the circulation, or to supplement the native function of the patient's left ventricle. The HeartMate II is placed just below the diaphragm and is connected to the left ventricle, returning blood flow to the aorta, the main artery that carries oxygenated blood to the entire body. An external, wearable system that includes a small controller and two batteries is attached by an external driveline. HeartMate II is smaller and easier to implant than prior FDA-approved devices, and with only one moving part, it is designed to provide exceptional reliability and improved patient quality of life. In total, more than 8,000 patients have been implanted with HeartMate II.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 18,000 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 the company's web site at http://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.
Many of the preceding paragraphs, particularly but not exclusively those addressing the company's current expected timelines for product development, clinical trials and commercialization, 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," "should," and other similar words. Forward-looking statements should not be read as a guarantee of future performance or results, and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, enrollment in and timing of clinical studies, and the effects of healthcare reimbursement and coverage policies. Forward-looking statements contained in this press release should be considered in light of 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 and in Thoratec's first quarter 2011 quarterly report on Form 10-Q, and as may be updated in subsequent 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.
SOURCE Thoratec Corporation