W.L. Gore & Associates said yesterday that it launched its Gore Tag conformable thoracic stent graft with active control in Australia, touting that the first procedures with the device have been performed in the region. The first implant procedures with the device were performed by Dr. Ian Spark of Adelaide, Australia’s Flinders Medical Centre, Gore said. […]
W.L. Gore & Associates
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that […]
Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study. The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee. “Patients with extreme proximal neck anatomies often […]
Gore launches anti-migration assurance program for Viabil stent
W.L. Gore & Associates said today it launched an Anti-Migration Assurance Program for its Viabil short wire biliary endoprosthesis through which it will provide replacement devices for patients whose device moves out of place within a year of implantation. The Flagstaff, Ariz.-based company said the short wire biliary endoprosthesis has an average migration rate of 0.2%, […]
W.L. Gore loses bid to toss verdict in stent graft patent loss to C.R. Bard
A Delaware federal judge this week dismissed an attempt from W.L. Gore & Associates to clear a jury finding from March which ruled that 1 of its stent patents was invalid in an ongoing patent spat with C.R. Bard (NYSE:BCR), Law360 reports. U.S. District Judge Leonard Stark denied 3 motions for judgement, including 2 motions arguing […]
Studies support anti-stroke PFO closure devices from Abbott, Gore
A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients. Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired […]
Gore touts reduced portal hypertension, complications in Viatorr Tips trial
W.L. Gore & Associates today released preliminary data from a trial of its Viatorr Tips endoprosthesis with controlled expansion, touting reduced portal hypertension treatment complications when compared to the company’s legacy Tips device and bare metal stents. Data from the study was presented at The International Liver Congress 2017 in Amsterdam, the Flagstaff, Ariz.-based company […]
Gore touts 1st commercial use of Tag thoracic stent graft
W.L. Gore & Associates said today its Tag conformable thoracic stent graft was used in its 1st commercial procedure after the system won CE Mark approval in the European Union last month. The procedure was performed by Dr. Giovanni Torsello and Dr. Martin Austermann of Munster, Germany’s St. Franziskus Hospital, the Flagstaff, Ariz.-based company said. “The enhanced […]
Gore wins FDA nod for Synecor preperitonial hernia repair system
W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor preperitoneal biomaterial hernia repair device, with plans to launch the device this week. The Synecor preperitoneal biomaterial is a hybrid biosynthetic hernia repair device designed for use in single-stage preperitoneal, onlay and retromuscular placements through open, laparoscopic and robotic procedures, the Flagstaff, […]
Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device […]
ViaCyte looks to cell replacement therapy to cure Type I diabetes
ViaCyte said today that it will begin clinical trials of its novel islet cell replacement therapy in development as a potential cure for Type I diabetes, after landing regulatory wins from the FDA and Health Canada. The company’s PEC-Direct candidate delivers stem cell-derived pancreatic progenitor cells in a device that is designed to enable direct […]
