August 9, 2010
LeMaitre Vascular Commences ENTRUST Trial of TAArget Thoracic Stent Graft
August 6, 2010—LeMaitre Vascular, Inc. (Burlington, MA) announced the initiation of the ENTRUST trial, its clinical investigation of the TAArget thoracic stent graft. Five centers will participate in the phase 1 feasibility study, which is being conducted under an investigational device exemption from the US Food and Drug Administration.
The first patient was treated by Karthik Kasirajan, MD, ENTRUST's national principal investigator, for four saccular aneurysms of the descending thoracic aorta that required treatment of more than 30 cm of aorta.
“The TAArget device is very trackable,” commented Dr. Kasirajan. “I found it to have great deployment accuracy and did not observe any wind-socking or bird-beaking in this case despite the need for a proximal landing adjacent to the left common carotid artery. The hydrophilic coating also greatly improves the ability to maneuver across tight iliac vessels. Despite the need for more than 30 cm of coverage, the long lengths (up to 24 cm) of this new device allowed for treatment with just two pieces.”
According to LeMaitre Vascular, the TAArget device's design allows for significant tapering of the device for anatomies that narrow through the descending aorta. Rather than a “step down” using multiple devices, the TAArget device can change diameters by up to 50% over the length of the device to accommodate these unique anatomies. TAArget, which is delivered through the TT Tortuous Tracker delivery system, also incorporates cartridge-loaded accessories that enable deployment of accessory segments through one sheath, thereby allowing for fewer introductions during the procedure.