SUNRISE, FL--(Marketwire - May 05, 2010) - Bolton Medical announced today that patient enrollment in the U.S. Clinical Trial to evaluate the RELAY Thoracic Stent-Graft for the treatment of thoracic aortic aneurysms has concluded. The study included 120 endovascular patients at 30 hospitals across the country.
The device is already approved for use in Europe and international markets, and to date, more than 3000 RELAY Thoracic Stent-Grafts have been implanted worldwide.
"Completing enrollment is an exciting step in the study," states National Principal Investigator and Associate Professor of Surgery and Radiology, University of North Carolina, Chapel Hill, NC, Dr. Mark Farber. "We expect to see excellent results in the patient follow-up data and anticipate the device to be approved for sale in the U.S. in 2011."
The RELAY Thoracic Stent-Graft system has the longest device length options (from 90-250mm). The system is also available in a wide range of diameters (from 22-46mm) including smaller caliber sizes which allow for repair of patients with smaller diameter aortas. In addition, the device features a unique delivery system that allows for excellent proximal conformability and controlled deployment.
During an actual procedure, the RELAY Thoracic Stent-Graft is placed inside the diseased aorta without a major surgical incision and seals off the aneurysm allowing normal blood flow to resume. Because it was designed specifically for the thoracic anatomy, it allows surgeons to achieve placement in difficult, curved or otherwise challenging parts of a patient's unique anatomy.
Thoracic Stent-Grafts are an alternative to traditional open surgery for patients requiring treatment for main thoracic pathologies. The endovascular stent-graft procedure generally results in a reduced hospital stay and a shorter recovery time for the patient.
Bolton Medical is a private company, with European operations based in Barcelona, Spain, and U.S. operations in Sunrise, Florida. Bolton Medical is a wholly-owned subsidiary of the Werfen Life Group, a diverse manufacturer and supplier of products for the medical industry.