COLORADO SPRINGS, Colo., The Spectranetics Corporation today announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) submission of the Bridge Occlusion Balloon. Building on the ...
CIEDs and lead extraction: How MedStar Washington Hospital Center is helping cardiac device patients
This content is provided by MedStar Washington Hospital Center. Surgically implanted cardiac devices are quite common with more than one million cardiac pacemakers implanted every year worldwide – ...
ORLANDO, Florida — Transvenous extraction of unused pacemaker or defibrillator leads poses a higher risk for death as an acute complication when it's performed by using a laser-based extraction sheath ...
Roughly one out of every five patients with an implantable device who is undergoing lead extraction will have incidental thrombi found on the transvenous leads, new prospective data show. The clots ...
When extracts of a medical device are required for a biocompatibility test protocol, a current practice is to follow the guidance in ISO 10993 Biological evaluation of medical devices–Part 12: Sample ...
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