HeartWare International announced updated clinical data from its bridge to heart transplantation (BTT) study, ADVANCE, and the Continued Access Protocol (CAP). The updated data for 241 patients enrolled in either the pivotal trial ADVANCE or CAP demonstrates a 180-day survival of 93%.
Results presented at the 25th European Association for Cardio-Thoracic Surgery (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 follow-up post implant from the Continued Access Protocol (CAP) allotments granted by the Food and Drug Administration (FDA) since the completion of enrolment 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, a principal investigator for HeartWare’s ADVANCE trial, 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 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% 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,” said Doug Godshall, president and CEO of HeartWare. “We appreciate the strong support for this new generation of mechanical circulatory assist device from our international customers and US clinical investigators as we continue to optimise implantation techniques and post-operative care.”
About HeartWare Ventricular Assist system
The HeartWare Ventricular Assist system features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump weighs approximately 5 ounces and displaces a volume of approximately 50 milliliters.
In 2009, HeartWare received CE marking for the HeartWare system, and in 2011 the Therapeutic Goods Administration (TGA) granted approval for the device in Australia. Today, more than 1,500 advanced heart failure patients globally have received the HVAD pump.
In other clinical development for the HeartWare Ventricular Assist system, HeartWare is currently enrolling a 450-patient destination therapy study at 50 US sites. The Company expects to complete enrolment in that study by mid-2012, with a two-year follow-up period for enrolled patients.
