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Two Year ROADMAP Data Showcases the Potential Benefits of HeartMate II LVAD in Ambulatory Heart Failure Patients

ST. PAUL, Minn. & WASHINGTON D.C., Apr 28, 2016 (BUSINESS WIRE) -- St. Jude Medical, Inc. STJ, +25.57% a global medical device company, today announced new, two-year data from the ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) Clinical Study. Two-year study results were presented today during the International Society for Heart and Lung Transplantation (ISHLT) 36 [TH] Annual Meeting and Scientific Sessions. The study met its primary endpoint of improved survival with enhanced functional status at 24 months in patients implanted with the HeartMate II [™] left ventricular assist device (LVAD) compared to optimal medical management (OMM) highlighting the benefit of the HeartMate II LVAD. Furthermore, survival with improved functional status, quality of life (as measured by EQ-5D Visual Analog Scale), and reduced severity of depression with HeartMate II LVAD compared to OMM at two years.

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The ROADMAP study was a prospective, multi-center observational study of 200 patients that evaluated the effectiveness of the HeartMate II LVAD compared to OMM in a patient population not dependent on inotropic medications (medications that alter the force of muscular contractions).

Seventy percent of the HeartMate II LVAD patients survived at two years, compared with 41 percent of those treated with medications alone (medically managed patients) on an as-treated basis. At two years of follow-up, 30 percent of patients in the HeartMate II LVAD group versus 12 percent of patients on OMM, met the primary endpoint of survival on the original therapy along with a 75 meter increase in six minute walk test distance (6MWD), a difference, which was statistically significant (p=0.012). These benefits were apparent even though the LVAD cohort was more severely ill, with 65 percent of HeartMate II LVAD patients compared with just 34 percent in the medical management group designated as INTERMACS profile 4 at baseline.

“The ROADMAP study shows that LVAD therapy is a treatment option for advanced heart failure patients not yet on inotropic therapy. Patients who desire to improve their quality of life and functional capacity may choose the option of LVAD before they become hospitalized and more critically ill,” said Dr. Randall...