CE Mark for Accolade pacemakers from Boston Scientific
Boston Scientific Corporation has received CE Mark approval for the Accolade pacemaker family. When implanted with the company's Ingivity leads, Accolade pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems. In addition, the Boston Scientific ImageReady technology offers the most flexible MRI options, allowing higher energy scan sequences, and featuring a programmable MRI timer designed to improve patient workflow.|
In addition to the CE mark approval and launch of the Accolade pacemaker family, Boston Scientific received CE Mark approval for the Visionist and Valtitude CRT-Ps with quadripolar pacing technology. When paired with the Acuity X4 pacing leads, these systems offer many options to reach and pace the target location in the left ventricle, potentially improving the patient response to CRT therapy. Dr. Stuart Harris, Clinical Director of the Essex Cardiothoracic Centre, Basildon, UK, performed the first implant of the Visionist X4 system.
Welcome to the Fluid Management Learning Zone. In this Learning Zone we provide an overview of fluid management, including albumin for sepsis and septic shock, guidelines for fluid management in liver cirrhosis and fluid management in cardiac surgery.
Related news and insights
Genentech/Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Oncopeptides announced that the company has decided to withdraw Pepaxto (INN melphalan flufenamide) from the market in the US, following the phase III OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the FDA. Pepaxto was granted accelerated approval on February 26th 2021.
Johnson & Johnson announced the FDA has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine.