W.L. Gore said yesterday that it won CE Mark approval in the European Union for its Cardioform ASD septal occluder for the percutaneous, transcatheter closure of ostium secundum atrial defects. The device won pre-market approval from the FDA for Cardioform ASD in June. The device is designed to close atrial septum defects of 8mm to 35mm […]
FDA clears Gore’s Cardioform ASD occluder
W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects. Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant. […]
Gore wins FDA nod for Gore Tag TEVAR system with Active Control
W.L. Gore & Associates said today that it won a nod from the FDA for its Gore Tag conformable thoracic endovascular aortic repair stent graft with Active Control. The newly cleared Gore Tag TEVAR product features the Flagstaff, Ariz.-based company’s Active Control system, which it said provides a controlled, two-stage deployment. The initial deployment is […]
Gore touts 12-month Tigris stent study data
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 […]
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