Two-Year Study Confirms Use Of LeMaitre Vascular's Endovascular Stent Graft To Treat Thoracic Aortic Disease

Burlington, MA - LeMaitre Vascular, Inc. recently announced the publication of a study in the Journal of Endovascular Therapy confirming the use of LeMaitre's endovascular thoracic stent graft in the treatment of thoracic aortic aneurysms and dissections. The two-year study was conducted by Lefeng Qu, MD and Dieter Raithel, MD of Nuremberg Southern Hospital.

LeMaitre Vascular's EndoFit Thoracic Stent Graft demonstrated 100% technical success in the study, a retrospective review of 87 patients undergoing endovascular repair of their thoracic aorta. There were no device- or aneurysm-related deaths and there was only a low incidence of device- or aneurysm-related complications.

The study noted that the availability of multiple custom sizes allowed treatment of "the majority of thoracic lesions." Thirty-five percent of patients in the study were treated with custom-manufactured stent grafts. The investigators further praised the device's cartridge-loading technique, which can reduce the number of delivery catheter insertions in cases requiring multiple stent grafts.

"We are pleased with the results of this study, which confirm the positive field reports we have been receiving since we acquired the EndoFit Thoracic Stent Graft in 2005," said George W. LeMaitre, Chairman and Chief Executive Officer of LeMaitre Vascular.

Noting that the company has recently launched its next-generation TAArget Thoracic Stent Graft in the European Union, Mr. LeMaitre continued, "For the new TAArget device, we added a uniform top stent option for improved fixation within the aorta. We also made it available with our new TT delivery system. The combination provides the vascular surgeon with increased deployment precision and reduces blood loss during the procedure."

Data from the study were compiled from 87 patients treated with the EndoFit stent graft for thoracic aneurysm or thoracic dissection between December 2005 and December 2007. The majority of patients were deemed unfit for open surgery due to high-risk co-morbidities. Twenty percent of cases were performed emergently. The investigators deployed the EndoFit Thoracic Stent Graft successfully in all cases. The mean procedure duration was 40 minutes.

The investigators conducted patient follow-up with CT-imaging at discharge, at one, three and six months, and then annually for the remainder of the study. Patient follow-up averaged 15.2 months. There were no device-related deaths. There was no stent graft kinking, collapse or dislocation, and no post-procedure rupture or conversion to open surgery.

The study was sponsored by LeMaitre Vascular and conducted at Nuremberg Southern Hospital in Nuremberg, Germany, where Prof. Raithel is Chief of Vascular and Endovascular Surgery. Prof. Raithel is a paid member of LeMaitre Vascular's endovascular advisory board.

SOURCE: LeMaitre Vascular, Inc.