National first at Mission Health: Surgeons implant first vascular devices in U.S. trial
Press release from Mission Health
ASHEVILLE, N.C. (Dec. 26, 2013) – In late November, two vascular surgeons performed the first two cases in a national endovascular stent-graft trial that could pave the way for the new device receiving Food and Drug Administration (FDA) approval for use in the United States.
The two procedures, performed at Mission Hospital on Nov. 25, 2013, involved placement of the Treovance® Abdominal Stent-Graft with Navitel® Delivery System. Carolina Vascular surgeons, John Henretta, MD, and Mike Douglas, MD, performed the procedures. The device is manufactured by Bolton Medical, which has international operations in Barcelona, Spain, and U.S. operations in Sunrise, Florida.
“Both surgeries went very well,” said Dr. Henretta. “Participating in clinical trials such as this one allows us as surgeons access to safe, effective, cutting-edge medical devices that we can carefully select to fit each individual case precisely. This device in particular is a promising option for patients who come to us with abdominal aortic aneurysms, which are life-threatening conditions. It was easy to use, and I look forward to where this trial will take us.”
The two surgeries mark the beginning of Phase II of the U.S. clinical trial of the stent-graft. Clinical trials are a limited study of a medical device in a select group of carefully monitored patients to determine the safety and efficacy of the device prior to FDA approval. This study involves 150 patients at 30 institutions across the country. The device is already approved for use in Europe. Abdominal stent-grafts, such as this one, are used to repair aneurysms in the abdominal cavity that occur in the vascular system closely related to the heart.
Mission Health participates in numerous clinical trials in a wide variety of medical specialties. Each trial protocol is carefully reviewed and progress is monitored, ensuring patients access to innovative medical devices and procedures close to home.
About Mission Health
Mission Health, based in Asheville, N.C., is the state’s sixth-largest health system and the region’s only not-for-profit, independent community hospital system governed and managed exclusively in western North Carolina. Mission Health was recognized as one of the nation’s Top 15 Health Systems in 2012 and 2013 by Thomson Reuters and Truven Health Analytics, respectively. Mission Health is one of only two medium-sized health systems to receive this recognition in 2012 and 2013, and the only health system in North Carolina to achieve that distinction.
Mission Health, which traces its roots in the region back to 1885, operates five hospitals, numerous outpatient and surgery centers and the region’s only dedicated Level II trauma center. Its medical staff consists of more than 1,000 physicians and is certified in more than 50 medical specialties and sub-specialties. Mission Health has seven Centers of Excellence: Cancer, Heart, Mission Children’s Hospital, Neurosciences, Orthopedics, Trauma and Women’s Health. Mission Hospital, located in Asheville, is the system’s flagship hospital and is licensed for 730 beds. It is the regional referral center for tertiary and quaternary care. It also includes Mission Children’s Hospital – the region’s only children’s hospital. Other Mission Health member hospitals include Angel Medical Center in Franklin, Blue Ridge Regional Hospital in Spruce Pine, McDowell Hospital in Marion and Transylvania Regional Hospital in Brevard. With approximately 9,500 employees and 700 volunteers, Mission Health is dedicated to improving the health and wellness of the people of western North Carolina. For more information, please visit mission-health.org.