Acutus Medical Inc. (ACM) announced that it has performed its First-In-Man clinical study of its cardiac catheter to provide highest-quality real-time 3-D mapping of the human heart.

St. Jude Medical Inc. announced CE Mark approval and European launch of its Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P). This CRT-P system offers more pacing options to deliver higher success rates, as evidenced by robust clinical data. Allure Quadra CRT-P brings the quadripolar lead technology to the pacemaker market. Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions. The Allure family of devices also offers heart failure (HF) diagnostics, including CorVue Impedance Monitoring, for improved patient management.

The U.S. Food and Drug Administration approved Kcentra (prothrombin complex concentrate, human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. 

Royal has completed patient enrollment in the CHILL-MI clinical study designed to further evaluate the safety and effectiveness of the company’s InnerCool RTx endovascular cooling system in patients with ST-elevation myocardial infarction (STEMI). 

Cook Medical has initiated a global voluntary recall of its Zilver PTX Drug Eluting Peripheral Stent based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent. Two adverse events, including one death, occurred in cases where a tip separation was reported.

The first patient in the United States has been implanted with the Boston Scientific Corporation ImageReady MR Conditional pacing system in the SAMURAI clinical trial. The study is designed to confirm the safety and effectiveness of the system in the magnetic resonance imaging (MRI) environment. While MRI images can help clinicians make informed decisions about treatment and care, most pacemakers are not compatible with MRI technology, and therefore patients may not have access to the sophisticated scanning capabilities of the diagnostic system.

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