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The Gen 2 Aria CV Pulmonary Hypertension System has been successfully implanted in the first patient as part of the ASPIRE PH clinical trial. The system aims to restore pulmonary artery function and reduce right heart workload. Initial results show reduced blood pressure and improved cardiac output post-procedure. The device has received Breakthrough Device Designation from the FDA and an IDE for pilot studies; it remains investigational with ongoing feasibility trials assessing safety, tolerability, and efficacy.
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