W L Gore & Associates has received the US Food and Drug Administration (FDA) approval for its Conformable Gore TAG, to be used for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta.
This approach would eliminate the need for open surgical repair, which has been the only approved treatment option available to date.
It is also reportedly the first device to receive approval for aneurysm, trauma and dissection indications.
The durable endoprosthesis has been designed to internally re-line the thoracic aorta and isolate the diseased segment from blood circulation; it is intended for multiple thoracic etiologies.
Gore aortic business leader Ryan Takeuchi said today’s approval further advances the use of endovascular devices as standard of care and allows more patients to benefit from this preferred treatment option.
“Gore has always been on the cutting-edge of endovascular treatment and was the first to gain approval for thoracic aortic aneurysm followed by aortic traumas using our Conformable GORE TAG Device,” Takeuchi said.
“We are proud to offer surgeons another first with the only FDA-approved, minimally invasive treatment for Type B dissections.”
The Conformable Gore TAG Thoracic Endoprosthesis is inserted into the femoral artery through a small incision in the groin via catheter and carefully guided up the leg artery through the abdomen into the chest and to the implantation site.
The device has an exclusive oversizing window range from 6%-33%, allowing physicians to choose the appropriate oversizing for the patient anatomy and specific etiology.
It is available in diameters of 21mm-45mm for the treating the patients with aortic diameters of 16mm-42mm. Tapered device configurations are also available.
The Conformable GORE TAG device resists compression, is easy-to-use, and offers maximum conformability for each patient’s anatomy.
Gore has received the FDA approval for repair of isolated lesions of the descending thoracic aorta, including traumatic aortic transections in January 2012 and for thoracic aortic aneurysms in November 2011.
According to GlobalData estimates, the thoracic aortic stent grafts market in the US, which was valued at $193.9m in 2012 and is expected to grow at a CAGR of 6.6% to reach $303m by 2019.