HOUSTON, Nov. 9 /PRNewswire/ -- Texas Heart Institute announced this week that Everardo Flores will be the first patient in the world to be supported by the HeartMate(R) II left ventricular assist device (LVAD) for a period of 365 days. Everardo, who celebrates the landmark anniversary on Thursday, received the heart pump as part of a U.S. feasibility pilot study by Thoratec Corporation , manufacturer of the device.
Then 18-year old Everardo was admitted to Texas Heart in October 2003 with severe cardiomyopathy and in need of a transplant. Too weak to withstand the surgery, he was implanted with the HeartMate II to keep him alive while regaining his strength for heart transplantation.
"Mr. Flores was in our ICU on maximum medical support and facing imminent death. Because of his small physical size there was no conventional pump that was suitable for him," said Dr. O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute at St. Luke's Episcopal Hospital. "The only reason he is alive and doing so well today is because the HeartMate II was available for him here."
The HeartMate II is designed to be a highly reliable and durable axial flow device. Because of its relative compact and efficient size, it can be used for a wide range of patients in need of long-term mechanical circulatory support. Weighing approximately 12 ounces and measuring approximately 1.5 inches in diameter and 2.5 inches long -- about the size of a D-cell battery -- it is significantly smaller than currently approved devices which weigh close to three pounds. As such, it may be suitable for a wider range of patients, including small adults and children. Nearly half of the trial patients have been female and the device has been implanted in patients as young as 14 years old.
The HeartMate II device is implanted just below the diaphragm and attached between the apex of the left ventricle and the aorta, the main artery that feeds blood to the entire body. An external system controller regulates pump speed. When implanted, HeartMate II assists the failing left ventricle, the heart's main pumping chamber, and helps generate the force necessary to propel oxygen-rich blood throughout the body. Without such circulatory support, patients are unable to produce blood flow adequate to meet their body's metabolic needs.
Everardo currently lives with his father in Waller, Texas, just outside of Houston. He is currently working to obtain his General Educational Development (GED) degree and assists with his father's business. In his spare time, Everardo helps to educate patients about the HeartMate II system, based on his personal experience.
"Since receiving the HeartMate II device, Everardo has been able to resume normal everyday activities," said Dr. Reynolds Delgado, cardiologist and medical director of Mechanical Support Devices at the Texas Heart Institute at St. Luke's Episcopal Hospital. "The device was not only life-saving but significantly improved his quality of life compared to before the surgery."
Thoratec has completed initial enrollment in its U.S. feasibility trial and filed an Investigational Device Exemption (IDE) supplement in October to begin a pivotal trial. When approved, the bridge-to-transplant trial will involve up to 25 centers in the U.S., and destination therapy trial will include up to 40 centers. The company hopes to initiate the pivotal trial, which will make this device more widely available by the end of 2004. Thoratec intends to seek FDA approval for bridge-to-transplant and destination therapy indications once the pivotal clinical trial is complete.
For more information, including photos and video of Everardo Flores; product animation, illustrations and images, enter ftp://ifisch.com into your URL browser. User: aadminist -- Password: (none).
About St. Luke's and Texas Heart Institute
World-renowned cardiovascular surgeon Denton A. Cooley, MD, founded the Texas Heart Institute in 1962 for the study and treatment of diseases of the heart and blood vessels. Together with the Institute's clinical partner, St. Luke's Episcopal Hospital, it has been ranked among the nation's top ten heart centers in an annual survey published by U.S. News & World Report for the past 13 years. For more information about the Institute, please visit http://www.texasheartinstitute.org/.
St. Luke's was founded in 1954 by the Episcopal Diocese of Texas. St. Luke's is home to the world-renowned Texas Heart Institute, founded in 1962. In 2001, St. Luke's earned the Magnet designation, the highest honor in patient care. It is the first hospital in Texas and the Southwest to be so honored. For more information about the hospital, please visit http://www.stlukestexas.com/.
About Thoratec Corporation
Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec VAD and HeartMate LVAS with more than 8,800 devices implanted in patients suffering from heart failure. Thoratec's product line also includes the Vectra(R) vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com/ or http://www.itcmed.com/.
Contacts: Kathy Watson Melinda Muse Texas Heart Institute St. Luke's Episcopal Hospital 832-355-6569 832-355-3040 kwatson@heart.thi.tmc.edummuse@sleh.comhttp://www.texasheartinstitute.org/http://www.stlukestexas.com/
Texas Heart InstituteCONTACT: Kathy Watson of Texas Heart Institute, +1-832-355-6569,kwatson@heart.thi.tmc.edu; or Melinda Muse of St. Luke's Episcopal Hospital,+1-832-355-3040, mmuse@sleh.com
Web site: http://www.texasheartinstitute.org/
Web site: http://www.stlukestexas.com/
Web site: http://www.thoratec.com/
Web site: http://www.itcmed.com/