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W.L. Gore & Associates

Gore announces some Excluder problems in Europe

January 17, 2020 By Sean Whooley

W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch. Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore […]

Filed Under: Cardiovascular, Endoscopic, Featured, Recalls, Regulatory/Compliance, Stent Grafts, Vascular Tagged With: W.L. Gore & Associates

Mayo Clinic, W.L. Gore team up on stem cell therapy treatments

December 11, 2019 By Nancy Crotti

Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease. […]

Filed Under: Business/Financial News, Featured, Implants, Regenerative Medicine, Research & Development, Stem Cells, Surgical, Wound Care Tagged With: Avobis Bio, Mayo Clinic, W.L. Gore & Associates

W.L. Gore officials think they can spur insulin delivery system innovation

December 6, 2019 By Chris Newmarker

W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore’s Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the company’s more than 60 years […]

Filed Under: Business/Financial News, Catheters, Diabetes, Drug Pumps, Drug-Device Combinations, Featured, Funding Roundup Tagged With: PhysioLogic Devices, W.L. Gore & Associates

Gore wins CE Mark for Cardioform ASD septal occluder

October 3, 2019 By Brad Perriello

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 […]

Filed Under: Cardiac Implants, Regulatory/Compliance Tagged With: W.L. Gore & Associates

FDA clears Gore’s Cardioform ASD occluder

June 4, 2019 By Fink Densford

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. […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: W.L. Gore & Associates

Gore wins FDA nod for Gore Tag TEVAR system with Active Control

May 15, 2019 By Fink Densford

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 […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Stent Grafts Tagged With: W.L. Gore & Associates

Gore touts 12-month Tigris stent study data

January 24, 2019 By Fink Densford

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 […]

Filed Under: Clinical Trials, Stents, Vascular Tagged With: W.L. Gore & Associates

Gore’s aneurysm device for tricky anatomies implanted in Europe

September 17, 2018 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Implants, Surgical, Vascular Tagged With: W.L. Gore & Associates

Gore picks up stealthy Pipeline Medical and its mitral repair program

September 6, 2018 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Mergers & Acquisitions, Replacement Heart Valves Tagged With: Pipeline Medical Technologies, W.L. Gore & Associates

Gore tests stent graft for deadly heart condition

August 27, 2018 By Nancy Crotti

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Stent Grafts, Surgical Tagged With: FDA, W.L. Gore & Associates

Gore touts regulatory wins for new balloon catheter

August 23, 2018 By Brad Perriello

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, […]

Filed Under: Catheters, Regulatory/Compliance, Stent Grafts Tagged With: W.L. Gore & Associates

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