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| Gore Excluder Iliac Branch Endoprosthesis--Courtesy of Gore |
Conglomerate W.L. Gore & Associates announced FDA approval of its Excluder Iliac Branch Endoprosthesis for the treatment of common iliac artery aneurysms or aortoiliac aneurysms.
The device is used in conjunction with Gore's Excluder AAA Endoprosthesis to "isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries," the company says. Gore last month announced that the Excluder AAA device has treated more than 250,000 since receiving a CE mark in 1997 and FDA approval in 2002.
It hopes for similar success with the Excluder Iliac Branch Endoprosthesis, which is made from the same polytetrafluoroethylene graft and nitinol stent material.
According to Endovascular Today more than 30% of patients with abdominal aortic aneurysms (AAA) also have related issues in the common iliac artery or internal iliac artery, located in the pelvic region.
Gore says that preserving blood flow to the internal iliac arteries reduces buttock claudication (cramping), sexual dysfunction, and colonic ischemia.
"FDA approval of this device is extremely important as it provides an iliac branch solution for a patient group with a previously unmet treatment need," said Ryan Takeuchi, Gore's aortic business leader, in a statement. "The GORE Excluder Iliac Branch Device has demonstrated high patency, conformability, and durability and provides physicians with an on-label, minimally invasive method of preserving flow to the internal and external iliac arteries. Not only is IBE the first off-the-shelf aortic branch device approved in the United States, it is a part of a complete portfolio of aortic branch solutions that are currently in clinical evaluation."
The device is installed using a delivery catheter and 16 French (5.33 millimeter in diameter) introducer sheath in the case of the iliac branch component, and 12 French (4 millimeter) introducer sheath in the case of the internal iliac component.
Approval came via the FDA's stringent PMA pathway for high-risk innovative devices, and necessarily included a clinical trial of 94 patients, according to a release.
The Iliac Branch Endoprosthesis earned a CE mark in 2013.
FDA approval comes amid an evolving competitive landscape in the AAA arena. Endologix ($ELGX) and TriVascular Technologies recently completed their $211 million merger, while Lombard Medical ($EVAR) acquired Silicon Valley's Altura Medical for up to $50.5 million.
Medtronic ($MDT) last year signaled its continued interest in the space with the $110 million acquisition of Aptus Endosystems and investment in Arsenal AAA in return for an option to acquire the company. The bigwig recently initiated a clinical trial of the Valiant TAAA Stent Graft System for thoracoabdominal aortic aneurysm.
- read the release