SVS and FDA partner on TEVAR

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To evaluate thoracic endovascular aortic repair (TEVAR) devices in the treatment of Type B aortic dissection, the SVS Patient Safety Organization is collaborating with the FDA and medical device manufacturers on a post-approval study.

The SVS PSO will use its Vascular Quality Initiative (VQI) registry to collect data on 400 cases with five-year follow-up for the Medtronic Valiant Thoracic Stent Graft with Captivia Delivery System and the Conformable GORE TAG Thoracic Endoprosthesis, both of which are FDA-approved devices available in the US.

The Gore and Medtronic TEVAR devices recently received FDA approval for treating descending aortic dissection. Approval was granted after safety and effectiveness was demonstrated in pre-market studies of the treatment of acute, complicated dissection.

Approval was broadened to include treatment of chronic and non-complicated dissection, with the proviso that the efficacy of TEVAR treatment of descending aortic dissection would be more fully analyzed through post-market study of these devices.

“This collaboration is the result of a year-long discussion with all stakeholders – the FDA, industry, and other surgical societies – to develop a quality improvement initiative that will provide real-world feedback.

This collaboration will meet the requirements of the FDA and provide relevant information to physicians and industry,” said Jack L. Cronenwett, MD, SVS PSO medical director.

An informational meeting for those who wish to participate in the study will be held at 6:30 am on Friday, June 6, during the Vascular Annual Meeting in Boston. All VQI members who perform TEVAR to treat descending thoracic aortic dissection are invited to attend to learn more about the project.

Participating sites will be selected by the Steering Committee to participate in the five-year project based on their volume of TEVAR procedures and their interest and ability to collect additional information and follow-up. Reimbursement of up to $3,000 per patient will be awarded for the expense of entering additional data.

VQI sites not selected for the five-year project are invited to participate in a separate project to evaluate TEVAR treatment of aortic dissection using the standard VQI TEVAR form, along with standard one-year follow-up. Sites will be reimbursed $400 for each TEVAR dissection procedure that is entered.

This one-year project will continue for approximately seven years, or until the last patient in the five-year study reaches their four-year follow-up time point.

“We anticipate that this will be the first of many opportunities to combine QI projects in VQI with regulatory and other needs for clinical data that address joint goals for the improvement of vascular health care,” said Richard Cambria, MD, who is overseeing the project.

Those interested in participating need to complete a survey at vsweb.org/TEVAR.

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