Vital Images Gets FDA Nod for Stent Planning

Advanced visualization firm Vital Images Inc. has received U.S. Food and Drug Administration 510(k) clearance for its fenestrated stent planning tool.

The addition of fenestrated stent planning workflow to the company’s endovascular stent planning (EVSP) application supports patients who don’t meet the recommended criteria for endovascular aortic aneurysm repair due to inadequate infrarenal neck anatomy, Vital Images said. With fenestrated stent planning, surgeons can make precise measurements for determining the size and placement of fenestrated stents tailored to each patient’s specific anatomy, according to the vendor.

A clock-angle tool provides measurements, including arc lengths, and surgeons can also customize their workflows using stent template editing tools, the company said. Computed tomography EVSP with fenestrated stent planning is available worldwide in version 6.7 of Vital Images’ Vitrea software.

“The Fenestrated Stent Planning workflow was developed to address a clinical need for these specialized and complex procedures,” said Jim Litterer, general manager at Vital Images. “This new capability in the endovascular stent planning package demonstrates our continued commitment to deliver innovative advanced applications with the ultimate goals of reducing procedure time, increasing predictability, and improving patient outcomes.”

Approximately 600,000 global cases of abdominal aortic aneurysms are diagnosed annually, according to industry data. Left untreated, these aneurysms can rupture, causing profound internal bleeding often leading to death within minutes. Endovascular aortic aneurysm repair with stents have shorter recovery times and better outcomes than alternative open surgical repair of aortic aneurysms, but require good pre-procedure planning, often using EVSP applications. Fenestrated Stent Planning is ideal for patients who do not meet the recommended criteria due to inadequate infrarenal neck anatomy which is not suitable for conventional aortic aneurysm repair with standard devices.

Vital Images, a Toshiba Medical Systems Group company, develops health imaging informatics solutions including advanced visualization, enterprise image viewing solutions and business intelligence technology.