W.L. Gore & Associates enrolled the 1st patient in its U.S. Gore TAG thoracic branch endoprosthesis LSA feasibility study in hopes of landing FDA approval for treatment of thoracic aortic aneurysms in the left subclavian artery.
The device enters the body through the femoral artery and features a bioactive surface for sustained anti-thrombotic bioactivity, Gore said. The 1st procedure was conducted by Dr. Himanshu Patel and Dr. David Williams at the University of Michigan in treating an 84-year-old woman, according to a Cath Lab Digest report.
“We dedicated significant time and effort into the development of our thoracic branch technology and it has become the foundation of our aortic branch portfolio," aortic business unit leader Ryan Takeuchi said in prepared remarks. "Earlier this year, we introduced our first branched device with the Gore Excluder Iliac Branch Endoprosthesis with much clinical success across Europe. Now with our Gore TAG Thoracic Branch Endoprosthesis, physicians will be able to treat a subset of patients that could not be considered for total endovascular repair in the past."
Newark, Del.-based Gore is currently in the midst of a long-running patent battle, most recently appealing a $860 million infringement loss to C.R. Bard. Gore has already started paying out the settlement, but is arguing that the plaintiff in the 2003 lawsuit, Bard Peripheral Vascular, lacked standing because the patent was actually licensed to BPV’s corporate parent, C.R. Bard.