Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil system for intracranial aneurysms and other neurovascular abnormalities. The Laguna Hills, Calif.-based company also said it inked an exclusive distribution deal with Phenox for the commercialization of Avenir in the U.S. and Europe. […]
Phenox touts pREset thrombectomy device trial data
German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits. The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety […]
Medtronic, Germany’s Phenox to open new plants in Ireland
Medtronic (NYSE:MDT) and German medical device maker Phenox are each planning to open new manufacturing plants in Galway, Ireland. Fridley, Minn.-based Medtronic said it plans to spend about $14.3 million (€13 million) building a new, 20,000-square-foot facility will be used to make its In.Pact Admiral drug-coated balloon. The plant is expected to employ about 100 workers, the […]
