Bolton Medical Enrolls First Patients in the U.S. Clinical Trial to Evaluate Treovance Abdominal Stent-Graft
Published: Jun 15, 2011
SUNRISE, FL--(Marketwire - June 15, 2011) - Bolton Medical, which specializes in endovascular treatments for thoracic and abdominal aneurysm repair, announced today it has begun its Bolton MEdical AbdomiNal StEnt GraFt TrIal with Treovance (B.E.N.E.F.I.T.). The first case was performed on June 9, 2011 by Michael C. Stoner, MD, Chief of Vascular and Endovascular Surgery at East Carolina University/East Carolina Heart Institute, Greenville, NC.
"The Treovance Abdominal Stent-Graft System performed very well," said Dr. Stoner. "The active fixation barbs coupled with the leg locking mechanisms on the stent-graft address durability concerns, particularly for patients with challenging anatomies." Regarding the delivery system, Dr. Stoner stated, "The delivery and deployment of the Treovance Stent-Graft are quite intuitive and I was very satisfied with the ability to fine-tune the proximal stent."
The second case was performed on June 10, 2011 by Edward Woo, MD, Vice-Chief, Associate Professor of Surgery at The University of Pennsylvania, Philadelphia, PA. "The device worked great. This was not a straightforward case, but it handled the anatomy very easily," said Dr. Woo. "This will definitely be an important next generation device."
The primary objective of the B.E.N.E.F.I.T. Clinical Study is to assess the safety and performance of the Treovance Abdominal Stent-Graft in subjects with infrarenal aortic aneurysms. Results of this study will support FDA submissions of the product in the United States. Phase One of the study includes 30 patients enrolled at 7 institutions located throughout the U.S. In Europe, the Treovance Abdominal Stent-Graft ADVANCE Study has been ongoing since March 2011.
The Treovance Abdominal Stent-Graft offers many key features which include:
- A three-piece, adaptable system that can accommodate a wide-range of anatomies
- Active Fixation through suprarenal and infrarenal barbs which allow for proximal and supplemental fixation in highly angulated necks
- A highly flexible design, making it conformable even 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 simple, yet accurate deployment.
Bolton Medical currently manufactures Relay and Relay NBS Thoracic Stent-Grafts. In international markets 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, more than 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 the Relay and/or Treovance clinical trials, please visit www.relayclinicaltrial.com or www.treovance.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.
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