L. Gore & Associates (Gore) today announced that the US Food and
Drug Administration (FDA) has approved the Conformable
GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute
and chronic Type B dissections of the descending thoracic aorta. This
durable endoprosthesis is the only device to receive FDA approval for
this indication. The Conformable GORE TAG Thoracic Endoprosthesis is
designed for multiple thoracic etiologies. Extensive clinical research
has been conducted with the device and it is the one and only device to
receive FDA indications for aneurysm, trauma and dissection.
An aortic dissection is the tearing of the innermost layer of the aortic
wall, allowing blood to flow between the inner and outer layers of the
vessel wall causing separation. If not stabilized, the dissection can
increase the risk of rupture, cause complications with blood flow to the
lower body and harm nearby organs. Until now, the only approved
treatment options were medical management or open surgical repair.
"Vascular surgeons have for some time awaited an approved indication for
treating certain Type B aortic dissection patients since the consensus
has been that endovascular stent graft repair has emerged as the
treatment of choice," said Richard Cambria, MD, Chief, Division of
Vascular and Endovascular Surgery and Co-Director, Thoracic Aortic
Center at the Massachusetts General Hospital Vascular Center in Boston.
"Now, surgeons will be able to present patients with a minimally
invasive treatment option and the exchange of information and experience
among surgeons will be more acceptable now that the procedure is
"Having an FDA-approved Type B dissection indication is very important,
as the impact this has on the endovascular community and the eligible
patient population is huge," said Joseph Bavaria, MD, Roberts / Measey
Professor of Surgery, Vice Chair in the Division of Cardiovascular
Surgery and Director of the Thoracic Aortic Surgery Program at the
University of Pennsylvania. "I applaud Gore for recognizing the urgent
need for an FDA-approved dissection indication and for being committed
to conducting a thorough and expertly run clinical study."
The Conformable GORE TAG Device offers conformability and ease of use,
while accommodating tortuous and tapered anatomy. The device resists
compression and has a broad oversizing window ranging from 6 to 33
percent. Physicians are able to choose the appropriate oversizing for
the patient anatomy, which is particularly important in dissection
patients due to the delicate nature of the disease.
The Conformable GORE TAG Thoracic Endoprosthesis is delivered via
catheter and inserted into the femoral artery through a small incision
in the groin and carefully guided up the leg artery through the abdomen
into the chest and to the implantation site. The device is available in
diameters of 21-45 mm, allowing for the treatment of patients with
aortic diameters of 16-42 mm. Tapered device configurations are also
"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," said Ryan Takeuchi, Gore Aortic Business Leader.
"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. We are proud to
offer surgeons another first with the only FDA-approved, minimally
invasive treatment for Type B dissections."
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic
solutions to complex medical problems for more than 35 years. During
that time, more than 35 million innovative Gore Medical Devices have
been implanted, saving and improving the quality of lives worldwide. The
extensive Gore Medical family of products includes vascular grafts,
endovascular and interventional devices, surgical meshes for hernia
repair, soft tissue reconstruction, staple line reinforcement and
sutures for use in vascular, cardiac, and general surgery. Gore is one
of a select few companies to appear on all of the U.S. "100 Best
Companies to Work For" lists since the rankings debuted in 1984. For
more information, visit www.goremedical.com.
GORE®, TAG®, and designs are trademarks of W. L. Gore & Associates.
Chempetitive Group for W. L. Gore & Associates
Kena Hudson or