Abbott (NYSE:ABT) is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official. In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of … [Read more...] about Abbott is launching its latest Navitor TAVI system in the U.S.
Technologies & Devices
Boston Scientific has positive Agent DCB study results
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue … [Read more...] about Boston Scientific has positive Agent DCB study results
PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device. The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient's … [Read more...] about PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, 46915, … [Read more...] about Medtronic has a serious catheter tubing recall
Zeus sale to private equity firm EQT closes
Zeus is officially under new ownership after private equity firm EQT closed on its acquisition of the medical tubing supplier. “Today marks the start of a new chapter for our company, and we’re excited to share this update with you,” Zeus said in an email to “industry partners” announcing the deal’s finalization. “We believe this partnership … [Read more...] about Zeus sale to private equity firm EQT closes
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary tension with associated heart failure. Paris, France-based Gradient already enrolled the first patient at Duke University … [Read more...] about Gradient begins pulmonary artery denervation trial in the U.S.
Stereotaxis submits Magic ablation catheter for U.S., European approval
Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval. The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. … [Read more...] about Stereotaxis submits Magic ablation catheter for U.S., European approval
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
Pentax Medical’s i20c video endoscopes wins CE mark
Pentax Medical this week announced it received CE mark approvals for new models of its i20c video endopscope series. The approval covers the Pentax Medical Video Colonoscope EC34-i20c, Pentax Medical Upper GI Scope EG27-i20c and the R/L Knob Adaptor OE-B17. Pentax Medical's i20c Video Endoscope Series, when used with the Inspira Video … [Read more...] about Pentax Medical’s i20c video endoscopes wins CE mark
FDA clears FujiFilm’s Scale Eye endoscopic imaging tech
FujiFilm today announced it received FDA 510(k) clearance for its Scale Eye endoscopic imaging technology. Scale Eye is part of the company's expanding Eluxeo endoscopic imaging system. It has a laser-equipped colonoscope and endoscopy support software that displays linear or circular vital measurements or scales on an endoscopy monitor. The … [Read more...] about FDA clears FujiFilm’s Scale Eye endoscopic imaging tech