W. L. Gore--known initially for its Gore-Tex fabrics (warm material for ski weather)--can now roll out the company's hybrid vascular graft in Europe. Gore's CE mark milestone comes two years after gaining FDA clearance for the product.
The company gained European approval based in part on positive 12-month follow-up data, as well as the product's track record elsewhere: 2,500-plus implants since its commercialization. According to the company, the CE mark covers the product's use as a vascular prosthesis to replace arteries damaged by aortic aneurysms, patients with trauma to their arteries in need of vascular replacement, as well as dialysis access. FDA officials cleared the product in 2010.
Privately-owned Gore already has steady track record with its endovascular grafts so far this year. In January, the FDA approved expanded use of the company's TAG thoracic endoprosthesis to help repair aortic tears in young trauma patients.
But not everything has been smooth sailing for Gore. The company has been fighting a fierce battle with GI Dynamics ($GID) over the right to market a bypass tube for obesity and Type II diabetes known as the EndoBarrier. Gore claims to co-own the patent and the dispute is heading to court.
- read the release
Like what you're reading?
Click here to get more news like this delivered to your inbox every day >>