HeartWare announces updated clinical data from BTT study, ADVANCE and CAP

HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced updated clinical data from its bridge to heart transplantation (BTT) study, ADVANCE, and the Continued Access Protocol (CAP). The updated data today for 241 patients enrolled in either the pivotal trial ADVANCE or CAP demonstrates a 180-day survival of 93 percent.

Results presented today at the 25th EACTS Annual Meeting in Lisbon, Portugal aggregated data from the 140 patients in HeartWare's ADVANCE clinical trial and an additional 101 patients with at least six months of followup post implant from the Continued Access Protocol (CAP) allotments granted by the Food and Drug Administration (FDA) since the completion of enrollment in the pivotal study.  The ADVANCE clinical trial is an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with advanced heart failure.

The data was presented by Mark S. Slaughter, M.D., in a session entitled HeartWare®: Results of the ADVANCE Bridge to Transplant Trial.  Dr. Slaughter, a principal investigator for HeartWare's ADVANCE trial, is Professor and Chief of the Division of Thoracic and Cardiovascular Surgery and Director of the Mechanical Assist Device and Heart Transplant Program at the University of Louisville.  

"Consistent with previously presented data from this study, we observed high survival rates for patients through the six-month endpoint, and particularly low observed rates for bleeding and infection," explained Dr. Slaughter.  "Adjustments in anticoagulation are contributing to reduced thrombus events, and overall adverse event rates remain low despite increased exposure to the device due to higher survival and a lower transplant rate."

Other observations reported during the presentation include:

• Only 21.6 percent of study patients had received a transplant at the six-month endpoint, reflecting longer waiting times for heart transplantation;
• Reduction in the rate of pump exchange for suspected thrombus to less than 0.03 events per patient year, since an adjustment in anticoagulation in March;
• Reoperations for bleeding and sepsis, and driveline infections were notably infrequent.

"This data from our ADVANCE Bridge-to-Transplant clinical trial reaffirms the potential utility of the HVAD Pump in improving treatment outcomes for end-stage heart failure patients," explained Doug Godshall, President and Chief Executive Officer of HeartWare.  "We appreciate the strong support for this new generation of mechanical circulatory assist device from our international customers and U.S. clinical investigators as we continue to optimize implantation techniques and post-operative care."

As announced in November 2010, the ADVANCE study achieved its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001].  Between August 2008 and February 2010, 140 patients at 30 hospitals in the United States received the HeartWare investigational device.  The final implant in ADVANCE was performed in February 2010, and the last follow-up evaluation at 180-days was in August 2010.  Three allotments of additional patients (54, 54 and 94) have been granted by the FDA, for a total of 202 additional patients.  HeartWare completed submission to the FDA of a premarket approval (PMA) application seeking approval of the HeartWare System for the bridge-to-transplant indication on December 27, 2010.