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Bearpac Medical has commercialized the Passio Pump Drainage System, a digital handheld device for drainage of malignant pleural effusions and malignant ascites. The device received FDA 510(k) clearance in August 2020 for pleural effusions, with home use indication cleared in December 2020, and peritoneal indication for malignant ascites cleared in December 2023. The device also received CE Mark certification in April 2022. The AESOP clinical trial launched in September 2023 at North Bristol NHS Trust to assess safety, efficacy, and patient experience.
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