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Progel™ Pleural Air Leak Sealant is an individual use product meant for application to visceral pleura after standard visceral pleural closure with, such as, sutures or staples, of seen air leaks incurred throughout resection of lung parenchyma.
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nnIn a subsequent minimally invasive clinical demo there were no machine relevant adverse gatherings or unanticipated adverse gatherings. The vast majority of AEs reported With this research ended up mild or reasonable in severity. Nearly all SAEs were pulmonary and expected events as Component of a lung resection medical procedures. Two patients died over the program of the examine, a person because of cardiac arrest and A different due to multi-program organ failure; neither ended up product similar or unanticipated.nnThe details of those scientific demo adverse occasions could be reviewed while in the IFU equipped Together with the product or service an d also available at nnCaution: Federal (USA) law restricts this device to sale by or on order of the accredited physician or adequately certified practitioner." " id="textual content-76d961b47a" class="cmp-text"> 1. Allen, Mark S. et al, “Prospective Randomized Study Analyzing a Biodegradable Polymeric Sealant for Sealing Intraoperative Air Leaks That Occur Through Pulmonary Resection” Annals of Thoracic Operation 2004; seventy seven:1792-1801. Pivotal examine. Info on file.
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