December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all ...

Medical artificial intelligence (AI) company Bay Labs announced a collaboration with Edwards Lifesciences focused on improving the detection of heart disease. The partnership involves multiple initiatives, including the development of new AI-powered algorithms in Bay Labs’ EchoMD measurement and interpretation software suite, the integration of EchoMD algorithms into Edwards Lifesciences’ CardioCare quality care navigation platform, and support for ongoing clinical studies at leading institutions.

New data from the Phase 3 CASSINI study showed a 60 percent reduction of venous thromboembolism (VTE, or blood clot) events with oral anticoagulant Xarelto (rivaroxaban) compared to placebo in high-risk patients with cancer. The composite primary endpoint of VTE occurrence did not reach statistical significance during the full study period. Bleeding rates were low, though higher with Xarelto.

Corindus Vascular Robotics Inc. announced that its CorPath technology was used to conduct the first-in-human (FIH) Telerobotic Intervention Study, Dec. 4 and 5, 2018, in India. This study represents the world’s first percutaneous coronary intervention (PCI) conducted from a remote location outside of the catherization lab.

BTG plc announced the first patients outside of a clinical trial have been successfully implanted with the BTG Sentry device, a bioconvertible inferior vena cava (IVC) filter. The BTG Sentry filter is designed to provide protection from pulmonary embolism (PE) for the period of transient risk and then bioconvert to leave a patent, unobstructed IVC lumen. This eliminates the need to retrieve and addresses the typical filter-related complications associated with conventional IVC filters.

New results from the DISRUPT PAD II study showed no perforations, embolization, reflow or abrupt closures with the Shockwave Peripheral Intravascular Lithotripsy (IVL) System in the treatment of calcified, stenotic, peripheral arteries. Results of the non-randomized, multi-center study were published in Catheterization & Cardiovascular Interventions (CCI).

Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first patient in its STELLAR U.S. Investigational Device Exemption (IDE) study. The study will evaluate the safety and effectiveness of Heliostar Multi-electrode Radiofrequency (RF) Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF). Up to 640 patients will be enrolled in as many as 40 clinical sites worldwide.