{"entity":{"id":"indwelling-pleural-catheters","kind":"technology","name":"Indwelling pleural catheters for malignant pleural effusion (PleurX, Rocket, Aspira, Passio)","aka":["Indwelling pleural catheter","IPC","Tunnelled pleural catheter","PleurX","Rocket IPC","Aspira","Passio"],"tldr":"A soft tube tunnelled under the skin into the chest, left in place so fluid that keeps building up around the lung can be drained at home, easing breathlessness without repeated hospital visits.","summary":"Long-term pleural catheters are cleared under product code DWM. Rocket Medical's indwelling pleural catheter kit (K163321, 17 August 2017) is indicated for \"intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion\", for palliation of breathlessness and for achieving pleurodesis. Merit Medical's Aspira pleural drainage system (K212696, 3 March 2023) and Bearpac Medical's Passio pump drainage system (K201404, 20 November 2020) carry similar indications. In the TIME2 randomised trial (106 patients, seven UK hospitals) breathlessness improved equally over 42 days with a catheter or with talc pleurodesis, but was better with the catheter at six months (mean difference 14 mm on a 100 mm scale); first hospital stay was shorter (median 0 against 4 days) and fewer patients needed further procedures (6 against 22 per cent), while adverse events were more frequent (21 of 52 against 7 of 54). For chest drains after lung surgery or for a collapsed lung, NICE says Thopaz+, a portable digital drain, should be considered (HTG465).","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA product code DWM: patient care suction apparatus","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=DWM"},{"label":"FDA 510(k) K163321: Rocket indwelling pleural catheter kit (17 August 2017)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163321"},{"label":"FDA 510(k) K212696: Aspira pleural drainage system (3 March 2023)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212696"},{"label":"FDA 510(k) K201404: Passio pump drainage system (20 November 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201404"},{"label":"Davies et al., TIME2: indwelling pleural catheter against talc pleurodesis (JAMA 2012)","url":"https://doi.org/10.1001/jama.2012.5535"},{"label":"NICE HTG465: Thopaz+ portable digital system for managing chest drains","url":"https://www.nice.org.uk/guidance/htg465"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["mesothelioma","nsclc","breast-cancer"],"sections":["supportive-care","devices"],"technologies":["indwelling-peritoneal-catheters","pleural-and-peritoneal-shunts","palliative-care"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["malignant-pleural-effusion","pleurodesis","pleural-effusion"],"trials":["time2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"A fenestrated silicone catheter is tunnelled subcutaneously into the pleural space with a cuff to anchor it and a one-way valve at the skin; patients or carers connect vacuum bottles or a pump to drain fluid every few days.","strengths":["Home drainage with a short or no hospital stay","Fewer repeat procedures than talc pleurodesis (TIME2)"],"limitations":["More adverse events than talc in TIME2, including infection","Needs regular drainage and carer support"],"since":2017},"route":"/technologies/indwelling-pleural-catheters/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"mesothelioma","kind":"cancer","name":"Mesothelioma","route":"/cancers/mesothelioma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"palliative-care","kind":"technology","name":"Early integrated palliative care","route":"/technologies/palliative-care/"},{"id":"indwelling-peritoneal-catheters","kind":"technology","name":"Indwelling peritoneal catheters for malignant ascites (PeritX, Rocket, Aspira, Passio)","route":"/technologies/indwelling-peritoneal-catheters/"},{"id":"pleural-and-peritoneal-shunts","kind":"technology","name":"Pleural and peritoneal shunts (Denver shunts, ACES)","route":"/technologies/pleural-and-peritoneal-shunts/"}],"term":[{"id":"malignant-pleural-effusion","kind":"term","name":"Malignant pleural effusion","route":"/terms/malignant-pleural-effusion/"},{"id":"pleural-effusion","kind":"term","name":"Malignant pleural effusion and ascites","route":"/terms/pleural-effusion/"},{"id":"pleurodesis","kind":"term","name":"Pleurodesis and indwelling pleural catheter","route":"/terms/pleurodesis/"}],"trial":[{"id":"time2","kind":"trial","name":"TIME2","route":"/trials/time2/"}]}}