Houston Methodist DeBakey Heart & Vascular Center in Houston, Texas, completed the first clinical research trial on third generation ventricular assist devices - the VentrAssist® Left Ventricular Assist Device (LVAD) Bridge to Cardiac Transplantation – Pivotal Trial.
Houston Methodist team, along with a select number of cardiac centers across the United States, participated in the trial to implant the VentrAssist pump as a bridge to transplant (BTT) device, supporting patients with severe heart failure and awaiting heart transplant. Dr. Matthias Loebe, Surgical Director of thoracic transplant and LVAD programs at Houston Methodist, implanted the final patient, completing enrollment in the 140-patient BTT pivotal trial.
Initial results for the trial are highly encouraging and when finalized, information from Houston Methodist and other participating hospitals will be presented to the FDA in the bid to gain marketing approval so that the pump can be made widely available to help patients with severe heart failure.
The FDA has granted Houston Methodist and the other trial hospitals approval to continue implanting the pump in BTT patients as part of a Continued Access Protocol (CAP) while the application for FDA approval is under way. Houston Methodist Hospital is also participating in another VentrAssist LVAD trial for the support of patients with severe heart failure who are ineligible for heart transplant.
"The need for more advanced technology for these critically ill patients is undeniable," Loebe said. "We have been extremely pleased with the performance of this third generation LVAD."
More than 5 million Americans are living with heart failure and 550,000 new cases are diagnosed every year.
Loebe and Dr. Guillermo Torre-Amione, medical director of Houston Methodist’s heart transplant and heart failure programs, led the trial, along with Drs. Brian Bruckner and Jerry Estep, Barbara Elias, VAD and heart transplant coordinator, and Pat Brinegar, research coordinator.
Ventracor is a global medical device company which produces the VentrAssist LVAD implantable blood pump as a therapy designed to improve the function of a weakened or failing heart. The VentrAssist LVAD is currently undergoing clinical trials within the US and is approved for sale in Europe and Australia.