April 04, 2011 09:00 ET
Bolton Medical Enrolls First Patient in the European Treovance Abdominal Stent-Graft Clinical Trial
SUNRISE, FL--(Marketwire - April 4, 2011) - Bolton Medical, which specializes in endovascular treatments for thoracic and abdominal aneurysm repair, announced today it has enrolled the first patient in its ADVANCE clinical trial to study the safety and performance of the Treovance Abdominal Stent-Graft with Navitel Delivery System. The case was performed on March 30, 2011, by Vicente Riambau, MD, Chief of Vascular Surgery at the Hospital Clinic, Barcelona, Spain.
"The Treovance Abdominal Stent-Graft performed very well," said Dr. Vicente Riambau. "The stent-graft is highly conformable and offers superior fixation through suprarenal barbs and uniquely designed infrarenal barbs." Regarding the delivery system, Dr. Riambau stated, "The low profile Navitel Delivery System offers deployment precision due to its proximal stent clasping. The introducer sheath is detachable, offering significant clinical benefits such as less access vessel trauma and the ability to perform a percutaneous approach."
The primary objective of the ADVANCE Study is to assess the safety and performance of the device in subjects with infrarenal aortic aneurysms. Results of this study will support CE mark of the product in Europe. The study will include 30 patients enrolled at 5 institutions located in Germany, Italy, The Netherlands and Spain. Enrollment of Bolton Medical's U.S. Clinical Trial for Treovance Abdominal Stent-Graft called B.E.N.E.F.I.T is expected to start in May 2011.
The Treovance Abdominal Stent-Graft offers many key features which include:
- Adaptability - the 3-piece modular system can accommodate a wide-range of anatomies.
- Unique Active Fixation - surprarenal and infrarenal barbs allow for proximal and supplemental fixation in highly angulated necks.
- Highly Flexible Design - making it conformable in difficult anatomies.
The Treovance Abdominal Stent-Graft is offered with the Navitel Delivery System, an intuitive low profile system with a mechanical advantage and a completely detachable sheath assembly. The Navitel Delivery System also includes the reliable proximal clasping system of the Relay Thoracic Stent-Graft providing accurate deployment.
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 adult patients. To date, approximately 5,000 Relay and Relay NBS Stent-Grafts have been implanted worldwide. Bolton anticipates US 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.