As it awaits a decision from the FDA on its PMA, Pulmonx Corp. touted positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr endobronchial valve for severe emphysema, including statistically significant reduction in the rate of respiratory failure in patients receiving the device. If approved, the therapy would offer a new choice for patients with limited options and who experience a poor quality of life.
Cerenovus, a unit of New Brunswick, N.J.-based Johnson & Johnson Corp. (J&J), received 510(k) clearance for the Embotrap II to capture and remove blood clots from the brain following an ischemic stroke.
Privately held Stimguard LLC has received CE mark approval for its sacral nerve stimulation (SNS) system to treat the chronic, intractable symptoms of overactive bladder (OAB). Pompano Beach, Fla.-based Stimguard has projected that the device will be available this summer.
With the field of robotic surgery continuing to heat up, Auris Health Inc. has entered a cooperative development and commercialization agreement with Neuwave Medical Inc., a subsidiary of Johnson & Johnson's (J&J) Ethicon Inc., focused on robotically assisted bronchoscopic ablation of lesions in the lung.
The FDA has cleared expanded claims for the Xpert Carba-R, a molecular test for the detection of carbapenemase-producing gram-negative bacteria, from Sunnyvale, Calif.-based Cepheid Inc. The additional claims extend use to the analysis of perirectal swab specimens, allowing test results to guide therapeutic strategies for pure colonies.
The Smart Pass sensing filter reduced the risk of all inappropriate shocks from the Emblem subcutaneous implantable defibrillator (S-ICD) system by 68 percent, according to real-world data presented at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions in Boston. These results came from an analysis of the Latitude database to assess how the use of the Smart Pass in patients implanted with the Emblem S-ICD. The analysis of Boston Scientific's device also was published online in the Heart Rhythm Journal.
