Aptus Endosystems Receives FDA Clearance for Aortic Securement System

Aptus Endosystems has announced it has received FDA clearance for a new aortic securement system, according to a news release.

 

The thoracic-length HeliFX system is designed for treating thoracic aortic aneurysms.

 

Similar to the original HeliFX system that was cleared in November 2011 and designed for treating abdominal aortic aneurysms, the thoracic-length HeliFX system features a longer delivery device with additional tip configurations to bring the helical EndoAnchor technology to the treatment of TAA, according to the company.

 

"FDA clearance of our new HeliFX System is a major milestone for Aptus and a significant technological advancement in the field of thoracic endovascular aneurysm repair," said James Reinstein, CEO of Aptus Endosystems, in the release. "Given our initial success in helping AAA patients with our EndoAnchor technology, we are excited to provide patients with TAA a viable treatment option to address the potential problems associated with TEVAR."

 

Clearance of the new HeliFX System in the United States allows the device to be used with Cook Medical's Zenith TX2, W.L. Gore's TAG and Medtronic's Talent Thoracic and Valiant endografts in both initial implant and secondary repair settings.

 

Aptus Endosystems is headquartered in Sunnyvale, Calif.

 

Related Articles on FDA Clearances:

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Tangent Medical Receives FDA Clearance for IV Catheter System

Iconacy Orthopedic Implants Receives FDA Clearance for Total Hip Replacement System

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