Gore this week announced it enrolled the first U.S. patient in its pivotal study for its ViaFort vascular stent. The prospective, non-randomized, multi-center, single-arm study will have a five-year follow-up and will evaluate the investigational Gore ViaFort vascular stent for the treatment of symptomatic iliofemoral venous obstruction. It will … [Read more...] about Gore enrolls first patient in Gore ViaFort vascular stent iliofemoral study
Stents
10-year data shows durable outcomes with Medtronic Endurant stent graft system
Medtronic (NYSE:MDT) announced positive results from its 10-year post-market registry for the Endurant stent graft. The Endurant stent graft system offers Endovascular aneurysm repair (EVAR) to treat patients with abdominal aortic aneurysm (AAA). Medtronic posted the real-world data at the 2023 Charing Cross Symposium in London, marking the … [Read more...] about 10-year data shows durable outcomes with Medtronic Endurant stent graft system
Gore enrolls first U.S. patient in vascular stent trial
W.L. Gore & Associates announced that it enrolled the first U.S. patient in a clinical trial for its Viafort vascular stent. Gore aims to evaluate Viafort for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without iliofemoral obstruction. The prospective, non-randomized, multi-center, single-arm study … [Read more...] about Gore enrolls first U.S. patient in vascular stent trial
Getinge wins FDA PMA for iCast covered stent
Getinge recently announced its iCast covered stent received FDA premarket approval to treat patients with iliac arterial occlusive disease. The iCast covered stent is a clinically-evaluated balloon expandable polytetrafluoroethylene-covered stent. It is delivered using a catheter to hold open and support the walls of structures within the body. … [Read more...] about Getinge wins FDA PMA for iCast covered stent
Olympus acquires GI stent maker Taewoong Medical for $370M
Olympus announced that it agreed to acquire Korea-based Taewoong Medical, a maker of medical devices, including stents, for $370 million. Taewoong Medical manufactures devices including gastrointestinal (GI) metallic stents. Olympus intends to use the acquisition to strengthen its GI endotherapy portfolio capabilities. Get the full story at our … [Read more...] about Olympus acquires GI stent maker Taewoong Medical for $370M
BD issues urgent field safety notice for Venovo venous stent system
BD has issued an urgent field safety notice for its Venovo venous stent system. The notice out of Germany warns of potential delayed deployment and silicone embolization if the proximal end of the Venovo venous stent system does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system. According … [Read more...] about BD issues urgent field safety notice for Venovo venous stent system
Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical
Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems. The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family. Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the trial. After … [Read more...] about Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical
The top 10 catheter innovation news stories of 2022
This year was a big one for catheter innovation as medtech companies large and small received regulatory approvals and researchers developed catheters that could soon make navigating the vasculature system easier. The numerous innovations weren't just limited to adults. One company launched a cryoablation catheter for children as young as 2 … [Read more...] about The top 10 catheter innovation news stories of 2022
Endologix AFX2 system wins FDA approval for PMA supplement
Endologix today announced it received FDA approval for a pre-market approval supplement relating to its AFX2 system. The expanded approval includes an updated warning and the most contemporary clinical information in the labeling for the AFX2 system. Clinical data was added to the instructions for use (IFU) to include: - Final results … [Read more...] about Endologix AFX2 system wins FDA approval for PMA supplement
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions … [Read more...] about FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
