SUNRISE, FL--(Marketwire - October 20, 2011) - Bolton Medical announced today it has completed enrollment in Phase I of its U.S., B.E.N.E.F.I.T (Bolton MEdical AbdomiNal StEnt GraFt TrIal with Treovance) Trial to evaluate the safety and efficacy of Treovance Abdominal Stent-Graft with Navitel Delivery System for use in endovascular aortic repair (EVAR) of abdominal aortic aneurysms. Physicians at six hospitals in the United States have enrolled thirty patients during Phase I. The final case was performed by Dr. Edward Woo and Dr. Ronald Fairman at the University of Pennsylvania Medical Center.
"The Bolton Treovance Phase I trial has been completed and I have been extremely happy with the performance of the device," said Dr. Edward Woo, Associate Professor of Surgery, Vice Chief and Program Director, Vascular Laboratory, Division of Vascular and Endovascular Surgery, University of Pennsylvania. "It has handled difficult aortic anatomy with excellent results and I look forward to Phase II."
Dr. Ronald Fairman, The Clyde F. Barker - William Maul Measey Professor of Surgery, Chief, Division of Vascular Surgery and Endovascular Therapy, Vice Chairman for Clinical Affairs, Department of Surgery, Hospital of the University of Pennsylvania commented on the final case, "Given the fact that this woman's anatomy did not qualify for any of the commercially available stent-grafts, being able to treat her with a Treovance graft was incredibly meaningful and I could not be more pleased with the results."
With its flexible design, multiple fixation points and wide range of sizes, the Treovance Abdominal Stent-Graft offers many advantages to EVAR patients. The low profile Navitel Delivery System is equipped with a detachable sheath and allows for controlled or rapid deployment of the Treovance Abdominal Stent-Graft. The Phase I trial includes thirty patients from six facilities throughout the U.S. Bolton Medical, Inc. is preparing for a pivotal Phase II trial in 2012.
"The Treovance Abdominal Stent-Graft with Navitel Delivery System is one example of Bolton Medical's innovative pipeline for endovascular aneurysm repair," said Oscar Rospigliosi, CEO and General Manager of Bolton Medical. "Achieving this critical milestone puts us one step closer to launching Treovance in the United States."
For more information on the Treovance device and clinical trial, please visit www. treovance.com
Bolton Medical currently manufactures Relay and Relay NBS Thoracic Stent-Grafts. They are indicated for the treatment of main thoracic aortic pathologies such as aneurysms, penetrating ulcers, pseudoaneurysms, and intramural hematomas in International Market. To date, approximately 6,000 Relay and Relay NBS Stent-Grafts have been implanted worldwide. Bolton anticipates U.S. FDA approval of Relay in 2012. For more information on Relay U.S. trial, please visit www.relayclinicaltrial.com.
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.