Abbott & #039;s Stellar Week, Cardinal Health & #039;s Supplier Drama, and More

Cardinal Health Severs Ties with Chinese Supplier 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.   Paclitaxel Device Hits a Speedbump in Europe 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's Many Irons in the Fire 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 bloo...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news