US firm Endologix has announced the successful treatment of the first thoracic aortic dissection patient with the company’s Powerlink® Dissection Stent System (DSS). The Powerlink DSS, a variant of the Powerlink technology without the ePTFE graft cover, is being used as an investigational device in the European Union and is not currently available in the United States.
The procedure was performed by Prof Dieter Raithel, from the Southern Clinic in Nuremberg, Germany. The patient – a 41-year-old female, treated in May 2006 – received cardiothoracic surgery for aortic valve replacement and conduit implantation to treat an aortic dissection that originated in the ascending aorta and extended into the iliac artery. On March 1 the patient was readmitted to treat a symptomatic aortic dissection distal to the surgical conduit.
“Having treated more than 400 patients over the past seven years for abdominal aortic aneurysm (AAA) with the Powerlink, I am excited to use a system based on this innovative stent technology to treat thoracic aortic dissection,” said Prof Raithel. “The implantation of the DSS, in combination with a proximal covered stent, was performed without problems. A control CT scan on March 5 demonstrated the diameter of the false lumen created by the aortic dissection to be 15% to 20% smaller in the segment treated by the Powerlink DSS in the first four days, and the patient was able to leave the hospital on March 6.”
An aortic dissection is a separation of the layers of the aortic wall with blood flowing through these layers rather than through the normal lumen of the vessel. It can lead to either an aneurysm caused by a degeneration of the aortic wall or induce a flap of tissue, resulting in malperfusion or occlusion of critical vessels with ensuing multi-organ damage, limb loss or paralysis.
Endologix president and chief executive officer Paul McCormick said: “The market size for thoracic aortic pathologies is poorly defined in the clinical literature and many fatal events due to this condition may go undiagnosed. However, the incidence of aortic dissection is estimated to be more than three times that of thoracic aneurysms.”