Bolton Medical Gains CE Mark for Treovance Abdominal Stent Graft With Navitel Delivery System

March 1, 2013—Bolton Medical (Sunrise, FL) announced the CE Mark approval and international launch of the Treovance abdominal stent graft with Navitel delivery system. The device is indicated for the endovascular treatment of abdominal aortic aneurysms in patients with a proximal neck length of up to 10 mm or an infrarenal neck angle up to 75°.

“The Treovance abdominal stent graft was successfully evaluated during the trial, which assessed its safety and performance in subjects with infrarenal aortic aneurysms,” said Prof. Roberto Chiesa, MD, the ADVANCE clinical study's principal investigator, in the company's press release. “The Treovance design can accommodate different anatomies and is able to tackle common anatomical constraints such as angulated and short necks while delivering good conformability.”

The Treovance abdominal stent graft feature includes a trimodular system in a range of diameters from 20 to 36 mm; lengths of 80, 100, and 120 mm; proximal bare stent with suprarenal fixation; supplemental infrarenal fixation for highly angulated necks;
 and the company's Lock Stent system that engages the limb extension to the main body avoiding module disconnection.

The Navitel delivery system includes a low-profile, 18-F introducer, a detachable introducer sheath to minimize the number of introductions, and a reliable clasp mechanism that captures the stent graft proximally and distally for controlled and precise deployment.

In September 2012, the company announced that its Relay thoracic stent graft was approved by the US Food and Drug Administration.