MassDevice is reporting that LeMaitre Vascular out of Burlington won FDA’s conditional clearance to go ahead with a feasibility study of the company’s TAArget thoracic stent graft. There are some vague conditions to meet before the FDA is fully satisfied — the company was tight-lipped about it but we suspect aorta safety is something the FDA doesn’t take lightly. When these conditions are met, the firm plans to perform a formal study comparing its product with traditional open chest thoracic aorta repair.
Some features of the TAArget from the product page:
Over 250 Custom Sizes
TAArget’s configurations include straight and tapered versions from 12 mm to 42 mm diameters with pre-loaded and cartridge loaded delivery options. Cartridge loaded option allows delivery of cuffs and extenders through the original delivery system.
Uniform External Fixation Design
Conforms to thoracic arch, allowing flow to native vessels while maintaining a secure position.
Eliminates the potential for suture breakage, reducing the risk of graft material tearing.
Laminated ePTFE Body
Has a low profile with high tensile strength while providing an impermeable barrier to prevent endoleaks and contrast blushing.
Two Radiopaque Markers
Are made of platinum and allow for precise placement and positive visualization.
TT DELIVERY SYSTEM
Ergonomic No-Slip-Grip Handle
With innovative valve system for improved hemostasis.
With improved shape, flexibility, and radiopaque marker for visibility.
Aids in navigation of device through tight and tortuous anatomies by reducing friction with the artery wall.
More from MassDevice : LeMaitre wins conditional FDA nod for feasibility study…
Product page: TAArget Thoracic Stent Graft…