Boston Scientific has issued an urgent recall of some of its Accolade pacemakers following reports of malfunctions that have been tied to two patient deaths.
Dublin medtech giant, Medtronic, today announced its Micra AV2 and Micra VR2 next generation miniature leadless pacemakers, which obtained FDA approval in 2023, have now also received a CE mark.
Seven years after bringing the world's first leadless pacemaker to the U.S. market, Medtronic has once again set a new pace in the industry with its next-generation leadless pacemakers.
Orchestra BioMed stays on key in extended study of blood pressure reducing device. The implant is meant to integrate with a patient’s existing pacemaker or other cardiac rhythm management device to help lower persistently high blood pressure. It does so by emitting patterns of bioelectronic therapy that modulate the autonomic nervous system and that can be adjusted as needed.
New data debunks traditional thinking that patients with pacemakers may not be eligible for or respond to tricuspid transcatheter valve repair.
Every year, more than one million cardiac pacemakers are implanted worldwide, and over 200,000 of these occur in the US.
Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).
Boston Scientific said its Ingenio pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) run the risk of incorrect transition to safety mode. In safety mode, there is a risk of inappropriate loss of pacing.
Abbott is recalling 61,973 Assurity and Endurity pacemakers from the U.S. after learning that electrical shorts can cause problems including reduced battery life.
The US Food and Drug Administration (FDA) on Tuesday alerted health professionals and manufacturers to a family of 12 cybersecurity vulnerabilities known as “SweynTooth,” which can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions.
Based on positive study results, Medtronic is seeking a PMA supplement from FDA to expand the use of Micra to patients with AV block and normal sinus rhythm. Micra, which is touted as the world's smallest pacemaker, was approved by FDA in 2016 for patients with atrial fibrillation or other dangerous arrhythmias such as bradycardia-tachycardia syndrome.