SUNRISE, FL -- (Marketwired) -- 12/03/13 -- Bolton Medical, a medical device manufacturer which specializes in endovascular treatments for aortic repair, announced today it has initiated its Phase II U.S. clinical trial to study the safety and effectiveness of the Treovance Abdominal Stent-Graft with Navitel Delivery System. The first two cases were performed on November 25, 2013 by John Henretta, MD and Mike Douglas, MD, Vascular Surgeons at Carolina Vascular, Mission Hospital, Asheville, NC.
"Both cases went really well. It's a nice device that allows for precise placement. Its delivery system is easy to advance through the iliac anatomy, and the material is non-porous. I feel secure about the device's long term-durability and we look forward to enrolling more patients," said Dr. John Henretta.
The third case was performed the same week on November 27, 2013, by Andres Schanzer, MD, Vascular Surgeon at University of Massachusetts Medical Center, Worcester, MA.
"The first Phase II Treovance endovascular aneurysm repairs mark an exciting time for Bolton Medical and the investigators involved in this trial. Their successful implantation is a credit to the quality of the device and the teams involved in its development and clinical application. We look forward to many more successful implants and the opportunity to treat patients with a life-threatening disease," said Dr. Matthew Eagleton, Vascular Surgeon at Department of Vascular Surgery of the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic and National Principal Investigator for the Phase II U.S. Treovance AAA Stent-Graft Clinical Trial.
The primary objective of the clinical study is to assess the safety and effectiveness of the Treovance Abdominal Stent-Graft in subjects with infrarenal aortic aneurysms. Results of this study will support approval of the product in the United States. Phase II of the study will include 150 patients enrolled at 30 institutions located throughout the United States.
The Treovance Abdominal Stent-Graft offers many key features which include: 1. a three-piece, adaptable system that can accommodate a wide-range of anatomies, 2. active fixation through suprarenal and infrarenal barbs permitting proximal and supplemental fixation in highly angulated necks, and, 3. a highly flexible design, conformable even in difficult anatomies.
The Treovance Abdominal Stent-Graft is offered with the Navitel Delivery System, an intuitive low profile system featuring mechanical advantage and a completely detachable sheath assembly. The Navitel Delivery System also includes the reliable proximal clasping system of Bolton Medical's Relay Thoracic Stent-Graft, allowing for accurate deployment.
Bolton Medical currently manufactures Relay and Relay NBS Thoracic Stent-Grafts. They are indicated for the treatment of thoracic aortic pathologies such as aneurysms, penetrating ulcers, pseudoaneurysms, and intramural hematomas in adult patients. To date, more than 10,000 Relay and Relay NBS Stent-Grafts have been implanted worldwide. Relay was awarded U.S. FDA approval on September 21, 2012.
Bolton Medical is a privately held company, with international 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.