Bolton Medical wins CE Mark for Treo stent graft

Bolton Medical said today it won CE Mark approval in the European Union for its Treo abdominal stent-graft for treating abdominal aortic aneurysms.

The endovascular aneurysm repair device is designed as a modular 3-piece system with dual proximal fixation and a unique proximal clasping mechanism, the Sunrise, Fla.-based company said.

“We believe that in EVAR, the tri-modular strategy is the best approach. This is because it allows you to deliver a tailored solution to each patient by selecting specific components to precisely work in that individual anatomy,” R&D veep Scott Rush said in prepared remarks.

The company said it will begin a limited release of the device in Europe beginning in October, and will officially launch the device in January.

“Stent migration and endoleaks are major concerns in EVAR. The Treo stent-graft offers both suprarenal and infrarenal fixation, distributing the attachment points in two different anatomical levels, which may work to reduce potential  endoleaks, particularly in angulated necks.  I expect this to lower re-intervention rates in my practice,” Carolina Vascular’s Dr. John Henretta said in a press release.

“We are looking forward to sharing the Treo technology with a global audience in January. We will showcase the technology with deployment demonstrations at our booth, expert panel discussions, and live case presentations,” CEO Paul Kuznik said in a prepared statement.

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