Terumo (TYO:4543) subsidiary MicroVention issued an urgent field safety notice to warn of a number of its Azur endovascular embolization products that may be missing the implant coil. Affected products include certain lots of the Azur peripheral coil system detachable 18 and the Azur peripheral coil system detachable 35, according to the notice out of Germany. […]
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention today released results from the WEB-IT pivotal trial of its Web aneurysm embolization system. Results from the trial were published in the online edition of the Journal of NeuroInterventional Surgery, the Aliso Viejo, Calif.-based company said. The trial enrolled a total of 150 patients across 21 U.S. centers and six international centers, MicroVention said. […]
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016. Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms. “We are proud to offer […]
Whether it’s the slew of mergers and acquisitions or tighter regulation, developments of recent years are having some surprising effects on the medtech industry, according to experts. Money is tight, the largest medical device companies are merging and it’s hard to see where regulation is going – medtech insiders have heard about such trends for years. […]
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke. The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used […]
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for a line of neurovascular stents. Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms. Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. […]
Terumo Corp. (TYO:4543) subsidiary MicroVention today released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low adverse composite outcomes. The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, […]
Terumo Corp. (TYO:4543) said today that its MicroVention subsidiary closed the $280 million acquisition of Sequent Medical and its Web aneurysm embolization device. The Web implant is made of a Nitinol mesh that is delivered in a “stent-like” manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. Sequent […]
MASSDEVICE ON CALL — Minneapolis-based CVRx Inc. launched a European registry to track treatment with its Barostim neo device, a heart implant for treatment of drug-resistant hypertension.
The Barostim neo device is designed to trigger the body’s natural blood flow regulation system by activating the baroreceptors, located in the carotid artery, which regulate cardiovascular function.
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TERUMO MEDICAL CORPORATION ANNOUNCES FDA 510K CLEARANCE OF THE K-PACK SURSHIELDTM HYPODERMIC NEEDLE WITH INTEGRATED PASSIVE SHARPS PROTECTION
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The gold standard in long-term glucose monitoring for patients with diabetes proved to be of limited value in dialysis patients, according to a new study at Wake Forest Baptist Medical Center.
Although the American Diabetes Association has deemed the HbA1c test an effective tool for diagnosing diabetes, kidney doctors recently determined that the HbA1c is not as useful for managing patients with diabetes and advanced kidney failure.