Medtech in a Minute: FDA Flags a Risk with Medtronic's Micra Pacemaker
Catch up on the biggest medtech news stories of the week in one minute or less.
November 19, 2021
A Big Moment for Minimally Invasive Glaucoma Surgery
iStar Medical just left its mark on the fast-growing market for minimally invasive glaucoma surgery with the European launch of its MINIject glaucoma implant. iStar said MINIject is now the only commercially available minimally invasive supraciliary device for glaucoma, meaning it is the only approved MIGS device designed to target the supraciliary space as a natural outflow pathway for the reduction of intra-ocular pressure. The company's CE mark news comes on the heels of Alcon announcing its intentions to acquire Ivantis (see link below for more).
FDA Flags a Rare but Serious Complication Risk Linked to Medtronic's Leadless Pacemaker
FDA penned a letter reminding heart surgeons about thre risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. Although cardiac perforation is a rare complication (occuring in roughly 1% of cases) of any pacemaker implant procedure, real-world data suggests that the risk of major complications following cardiac perforation may be higher in patients who receive a Medtronic Micra leadless pacing system versus a traditional transvenous pacemaker. The Medtronic Micra is the only leadless cardiac pacemaker on the U.S. market.
New Robotics Center Coming to Germany
Smith & Nephew plans to build a digital surgery and robotics innovation center in Munich, Germany. Expected to open in late 2022, the new center will bring healthcare professionals from Europe, Middle East, and Africa together with the company's R&D and medical education teams to explore digital surgery and robotics techniques and technologies. At the heart of this will be Real Intelligence, Smith & Nephew's digital ecosystem, including the new robotics-assisted surgical system CORI.
And in case you missed our last Medtech in a Minute report...
Alcon Takes Another Run at Glaucoma Surgery
Alcon said it plans to acquire Ivantis, the developer of the Hydrus Microstent, for $475 million. There is also the potential for milestone payments. The acquisition, which is set to close in the first half of 2022, would give Alcon another chance to compete the minimally invasive glaucoma surgery market. Alcon previously sold the Cypass Micro-Stent when it was part of Novartis, but in 2018, Alcon voluntarily pulled all versions of the Cypass Micro-Stent from the global market based on a new analysis of five-year post-surgery data.
GE Healthcare to Go It Alone
It looks as though GE Healthcare will become its own public company after all, despite a false start a few years ago. This is expected to happen in 2023 as part of a three-way split that will create three public companies. GE said it will combine its renewable energy, power, and digital businesses into a separate company in a second spin-off slated for 2024. The remaining GE business will focus on aviation.
Philips Has Its Heart Set on Cardiologs
Philips plans to acquire Cardiologs for an undisclosed sum in a deal set to close in the coming months. Cardiologs' technology has been CE-marked and FDA cleared for the detection of cardiac arrhythmias.
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