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The first clinical trial of a full-support ventricular assist device to utilize an implant technique other than sternotomy, the HVAD LATERAL™ Study is a prospective, multi-center, IDE, single-arm clinical trial that has enrolled 145 patients at more than 30 hospitals in North America. The trial population includes patients with end-stage heart failure who have not responded to standard medical management and who are eligible for cardiac transplantation. Completion of enrollment was announced on April 27, 2016. (Read Press Release)

The trial will evaluate thoracotomy (study arm) and median sternotomy (control arm) on survival, adverse event rates, quality of life metrics, perioperative bleeding and transfusions, length of stay, and time on cardiopulmonary bypass. Endpoints will be compared between the two groups of patients. The primary survival endpoint will be measured at six months post-implant and compared to a performance goal.

The principal investigators for the trial are Ed McGee, M.D., FACS, Director of the Heart Transplant & Ventricular Assist Device Program and Professor, Department of Thoracic and Cardiovascular Surgery at Loyola University Chicago Stritch School of Medicine and Anson Cheung, M.D. BSc MSc FRCSC, Surgical Director of the Cardiac Transplant Program of British Columbia and Clinical Professor, Department of Surgery at The University of British Columbia.

U.S. ENDURANCE™ Supplemental Trial

The most detailed study of destination therapy with continuous flow VADs as well as comparison of outcomes and adverse events with the two most widely-used devices.

In this investigational device exemption supplement to the original ENDURANCE, HeartWare will enroll up to 310 patients receiving the HVAD® System, as well as up to an additional 155 control patients using a randomization scheme consistent with the original ENDURANCE protocol. Patients will be followed for 12 months after implant. HeartWare intends to incorporate the data from this new cohort into an anticipated Pre-Market Approval (PMA) Application seeking approval for the HVAD System for the Destination Therapy indication.

The protocol for this cohort is designed to confirm clinical observations that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events. Enrollment at the 50 participating centers began late 2013.

U.S. ENDURANCE™ Destination Therapy Trial

HeartWare’s first destination therapy clinical trial cohort, ENDURANCE, is a prospective, randomized, un-blinded, multi-center, non-inferiority clinical trial to evaluate the use of the HVAD® System as a destination therapy in advanced heart failure patients. During the Opening Plenary Session at the 35th Annual International Society for Heart and Lung Transplantation in Nice, France on April 16, 2015, HeartWare announced that data from ENDURANCE successfully demonstrated that this trial achieved the primary endpoint.

Between August 2010 and May 2012, 446 patients were enrolled at 48 U.S. hospital centers and were randomly selected to receive either the HVADSystem or, as part of a control group, any alternative Left Ventricular Assist Device (LVAD) approved by the U.S. Food and Drug Administration (FDA) for Destination Therapy, in a 2:1 ratio. The study population was selected from patients with end-stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation.

The primary endpoint is survival free from disabling stroke (Modified Rankin Score ≥4) at two years, defined as alive on the originally-implanted device, transplanted or explanted due to patient recovery. Investigators for the study have reported that 55.0% of the investigational device patients attained the primary endpoint of the trial. In comparison, 57.4% of patients in the control arm achieved primary endpoint of the study. Based on these results for the primary endpoint of the ENDURANCE study, non-inferiority of the investigational device compared to control, was established (p=0.0060).

HVAD System improvements, including sintering of the inflow cannula, resulted in improved outcomes of investigational device patients. Among the 200 patients who received the investigational device with a sintered inflow cannula, an enhancement granted by the FDA in April 2011, 57.5% successfully attained the primary endpoint. Today, the HVAD System, featuring the HVAD® Pump is only available with the enhanced sintered inflow.

In addition, patients had significant and sustained improvements in NYHA heart failure classification and quality of life measures after implantation of the HVAD System.

Other secondary endpoints, including adverse event profiles, were also collected.

ENDURANCE is the largest trial to date for the long-term use of a left ventricular assist device.

The principal investigators of the trial are Francis D. Pagani, M.D., Ph.D., surgical director of the Adult Heart Transplant Program and director of the Center for Circulatory Support at the University of Michigan Health System and Joseph Rogers, M.D., senior vice chief for clinical affairs, Division of Cardiology and Mechanical Circulatory Support Program at Duke University.

U.S. ADVANCE Bridge-to-Transplant Trial

The study was a multi-center (30), 140-patient, prospective trial designed to evaluate the HVAD® System as a bridge to heart transplantation for patients with end-stage heart failure. Patients were followed for ≥ 180 days after implant or until cardiac transplantation, device explant for recovery, or death. The published data from the ADVANCE Trial reported 94% survival at 180 days. The FDA approved a total of 4 IDE (Investigational Device Exemption) supplements that allowed HeartWare to enroll 256 additional patients in the ADVANCE Trial under a Continued Access Protocol (CAP). The ADVANCE Bridge-to-Transplant trial received a positive recommendation from the Circulatory System Devices Advisory Panel in April 2012, followed by approval from the FDA in November 2012.

International CE Trial

In late 2008, HeartWare completed enrollment of a 50-patient international clinical trial for the HVAD® System. The study was a multi-center, prospective, non-randomized, single-arm study, enrolling patients across five participating centers. The company received CE Marking approval in January 2009 based on data submitted for the first 25 patients.

The purpose of the international trial was to evaluate the safety and efficacy of the HVAD System as a bridge to cardiac transplantation in patients eligible for cardiac transplantation with refractory, end-stage heart failure at risk of death. The primary endpoint was survival to anesthetic induction for heart transplantation or survival to 180 days on the device and listed for transplantation.

Clinical results from the first 23 patients enrolled in the international trial were presented by Dr. Georg Wieselthaler at the ISHLT Meeting in Boston, April 2008. Of these first 23 patients, 21 (or 91%) successfully met the primary endpoint of the trial, namely survival to 180 days or transplantation.

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