FDA Clears Vital’s TAVR Planning Application

In short

Vital Images, Inc., a Toshiba Medical Systems Group Company and leading provider of advanced visualization and analysis solutions for healthcare providers, has received FDA 510(k) clearance for its CT TAVR (Transcatheter Aortic Valve Replacement) planning application.

Background

TAVR procedures are used to replace faulty aortic valves with artificial valves using endovascular techniques on patients who cannot withstand invasive surgeries.

The minimally invasive approach to aortic valve replacement known as Transcatheter Aortic Valve Replacement (or Implantation) is developing rapidly. The procedure is relatively straight forward when you know how, but there is a learning curve and there are clearly do’s and don’t’s. Vital’s newly cleared CT TAVR planning application is used in the planning process to visualize and measure vascular anatomy for the evaluation, treatment and follow up of aortic vascular disorders.

Company comments 

“TAVR procedures are becoming more common and as a result, our customers are being asked to provide more information in the planning stages of these types of procedures,” said Justin Noznesky, vice president of marketing and business development at Vital Images, Inc. “Vital is pleased to offer new tools like our CT TAVR planning application that can help our customers provide meaningful information to make clinical decisions.”

Source: Vital Images, Inc., Globe Newswire