W.L. Gore & Associates today released 12-month results from a registry study of its Gore Tigris vascular stent designed to treat peripheral artery disease in the superficial femoral artery and proximal popliteal artery, touting that the device was shown to be safe and effective. Results from the trial were presented at the LINC 2019 meeting […]
Gore’s aneurysm device for tricky anatomies implanted in Europe
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles […]
Gore picks up stealthy Pipeline Medical and its mitral repair program
W.L. Gore & Assoc. said today that it acquired stealthy Pipeline Medical Technologies and its mitral repair program for an undisclosed amount. Santa Rosa, Calif.-based Pipleline is developing a transcatheter device designed to duplicate the efficacy and outcomes found when mitral valve chords are repaired via open heart surgery. Gore said it plans to run the […]
Gore tests stent graft for deadly heart condition
W. L. Gore & Associates announced the first implant of its ascending stent graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The surgery was part of Gore’s ARISE study, the first multicenter, early feasibility study approved by the FDA to investigate how […]
Gore touts regulatory wins for new balloon catheter
W.L. Gore & Assoc. said today that its molding & occlusion balloon won a trifecta of regulatory nods in the U.S., Japan and Europe. The Flagstaff, Ariz.-based company said the device is designed to deliver stent grafts or temporarily occlude large-diameter vessels during endovascular aortic repair procedures. In addition to 510(k) clearance from the FDA, […]
Gore touts first use of Tag conformable thoracic stent graft in Australia
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. […]
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 […]
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