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filler@godaddy.com
Safety: Current distal guidewire segment design is subject to Left Ventricular perforation (~ 5% incidence) with subsequent pericardial tamponade, a serious complication with high morbidity. Also, current approaches use either a) catheter based venous pacing requiring additional access adding increased radiation exposure, added risk of vascular bleeding, thrombosis, and infection orb) product modification (manual PTFE coating removal) which can lead to pacing intermittency or failure.
Efficacy: Current guidewires are not designed to optimize delivery via tortuous anatomy and through stenotic aortic valves. Current standard of care uses either, a wire designed for peripheral vasculature, which performs marginally, or a wire designed for non-repositionable valves. Temporary venous pacing adds increased device and procedural cost (venous access and delivery to the right atrium).
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