Boston Scientific Launches Captivator
Boston Scientific has begun marketing its Captivator endoscopic mucosal resection device, a minimally invasive alternative to esophagectomy. The device enables the staging and removal of precancerous tissue and early esophageal cancer in the upper gastrointestinal tract in an outpatient setting. The Marlborough, Mass., devicemaker also has enrolled the first patient in a multicenter postmarket registry aimed at studying the Captivator’s use in removing abnormal tissue growth in Barrett’s Esophagus, a common precursor to cancer.
Medtronic Snaps Up Lazarus Effect
Device giant Medtronic has acquired Lazarus Effect, a producer of acute ischemic stroke products used to capture and remove clots, in an all-cash transaction valued at $100 million.
Lazarus Effect manufactures a technology that complements Medtronic’s Solitaire stent retriever platform. The device, dubbed the Lazarus Cover, received CE mark approval in November 2014. Regulatory approval in the U.S. is pending.
FDA Greenlights Hearing Aid
The FDA has given its blessing to a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. Developed by Menlo Park, Calif.-based EarLens, the contact hearing device is intended for adults with mild to severe sensorineural hearing impairment. It differs from traditional hearing aids in that the tympanic membrane transducer component is custom-molded to the patient’s eardrum and contains a driver mechanism that directly stimulates the membrane.
FDA Approves Bayer’s Betaconnect
The FDA has signed off on Bayer HealthCare’s Betaconnect, an electronic autoinjector for the treatment of relapsing-remitting multiple sclerosis. The device offers customizable injection speed and depth settings. Betaconnect will be available in early 2016 for patients taking Betaseron, a drug used to reduce relapses in people with relapsing forms of the disease.
Merck, Pfizer to Collaborate With Dako
Pharmaceutical giants Merck and Pfizer will work with Agilent Technologies' Dako unit, with an eye on developing a companion diagnostic test. The agreement enables the companies to develop the test to assess programmed death-ligand 1 protein expression levels in tumor tissue, along with its microenvironment. The test is part of the protocols in ongoing clinical trials of avelumab, an investigational immune checkpoint inhibitor.
Galway, Ireland-based Neuravi has launched the EmboTrap revascularization device for the treatment of acute ischemic stroke. The device will be marketed through the sales and distribution network in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland. The device is designed to retrieve and retain clots while restoring blood flow to the brain. It is not approved in the U.S.