Cardinal Health nixed its relationship with Suqian, China-based Siyang Holymed after learning that the FDA-authorized supplier had shifted production of Cardinal's surgical gowns to non-approved sites without the proper controlled environments. Unable to ensure the sterility of the gowns produced under those conditions, the company has recalled or initiated a corrective action on 2.9 million procedure packs containing the affected gowns.
Surmodics is seeking a CE mark for its SurVeil drug-coated balloon but the CEO says the European notified body has temporarily halted CE mark reviews for new paclitaxel devices pending additional follow-up data from studies on current paclitaxel devices. The holdup is directly related to a meta-analysis published in late 2018 that showed an increased risk of death for patients treated with paclitaxel balloons and stents.
Abbott has been on a tear the last couple weeks with plans for a new atrial fibrillation (AFib) trial, CE mark for its transcatheter mitral valve implantation (TMVI) system, and a breakthrough device designation for a fully implantable left ventricular assist system (FILVAS). The FDA-approved CATALYST trial will see how Abbott's Amplatzer Amulet Left Atrial Appendage Occluder stacks up against a newer class of blood thinners for AFib. The company also won CE mark for the Tendyne TMVI system, which it inherited through its 2015 acquisition of Tendyne. And last but not least, FDA bestowed its increasingly popular breakthrough device designation on Abbott's FILVAS. The technology, which Abbott inherited through its St. Jude Medical acquisition, builds on the HeartMate 3 LVAD.