Jupiter Endovascular today announced the first two patients treated in a study of its Vertex pulmonary embolectomy system. Investigators treated two patients in the SPIRARE I study of the Vertex system using the company's Endoportal Control platform technology. Dr. Grzegorz Kopec, Dr. Jakub Stepniewski, and Dr. Krzysztof Bartus performed the … [Read more...] about Jupiter Endovascular announces first cases with Vertex pulmonary embolectomy system
Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE:EW) announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe. The launch expands the continent’s minimally invasive treatment options to a broader range of patients with congenital heart conditions. Edwards recently received CE mark for … [Read more...] about Edwards launches Sapien 3 valve with Alterra prestent in Europe
Merit Medical to buy Cook Medical’s lead management portfolio
Merit Medical Systems (Nasdaq:MMSI) announced today that it agreed to acquire Cook Medical's lead management portfolio for $210 million. Cook Medical's lead management business provides medical devices and accessories used in lead management procedures. These procedures occur in patients who need a pacemaker or an implantable … [Read more...] about Merit Medical to buy Cook Medical’s lead management portfolio
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed … [Read more...] about FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
Penumbra wins CE mark for computer-assisted thrombectomy tech
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its computer-assisted vacuum thrombectomy (CAVT) technologies. The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems … [Read more...] about Penumbra wins CE mark for computer-assisted thrombectomy tech
Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP). The FDA's approval of the new labeling for the pacing combination makes the products the first and only stylet-driven lead and dedicated delivery catheter system approved by the FDA for LBBAP, … [Read more...] about Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
Johnson & Johnson MedTech's Shockwave Medical today announced the full U.S. launch of its Shockwave E8 peripheral IVL catheter. Santa Clara, California-based Shockwave launched the intravascular lithotripsy (IVL) catheter following FDA clearance. It designed the catheter to optimize the treatment of patients with calcified femoro-popliteal … [Read more...] about J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
The FDA issued a notice deeming a recall of Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] McGrath Mac video laryngoscopes Class I, the most serious kind. This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes … [Read more...] about Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could … [Read more...] about Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
