Gore wins FDA nod, launches Viatorr Tips endoprosthesis in US

W.L. Gore & Associates said today it won FDA premarket approval for and launched its Viatorr Tips endoprosthesis with controlled expansion designed for transjugular intrahepatic portosystemic shunt procedures. The Newark, Del.-based company said that the newly cleared Viatorr Tips endoprosthesis is designed with proprietary ePTFE graft lining to minimize transmural permeation of bile and mucin. Gore added that the addition of controlled expansion allows operating physicians to start at 8mm, the smallest diameter, and increase balloon size during implantation to optimize the diameter until the target pressure gradient is reached. “I used the new Gore Viatorr Tips endoprosthesis with controlled expansion in the first U.S. patient with life threatening hepatorenal syndrome and impending liver failure, with nine cc of iodinated contrast. She was discharged to hospice the next day, but three weeks later, she is at home, free of ascites, jaundice, encephalopathy, and with great renal function. She’s headed to Florida for six weeks. The ability to tune the diameter of the Gore Viatorr Tips endoprosthesis with controlled expansion will let me better serve patients and expand the role of TIPS in patients with need,” Dr. Ziv Haskal said in a prepared statement. The company said it is also releasing a new Gore Tips set, composed of the specialized Gore Tips needle and Gore Tips sheath. On Monday, Gore said it won Health Canada approval for its Tigris dual-component vas...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Stents W.L. Gore & Associates Source Type: news