protogelProgel™ Pleural Air Leak Sealant is the sole sealant FDA authorised and clinically tested to seal air leaks in both equally open and minimally invasive thoracic surgery2. Progel™ is really a specialised product or service created with a novel combination of energy, flexibility and adherence that make it possible for it to increase and deal While using the lung throughout respiration.
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Progel™ Pleural Air Leak Sealant has been proven to successfully seal air leaks throughout lung surgical procedure, decreasing duration of hospitalization by 1.nine days on typical, likely reducing linked problems and offering cost-of-treatment savings1
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Progel, for example, is the sole solution which is FDA-accepted being an adjunct to the therapy of pleural air leaks that occur in the course of an open thoracotomy. This surgical sealant sorts an exceptionally flexible hydrogel which is specially made for use about the lungs.
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nnIn a subsequent minimally invasive scientific trial there were no product relevant adverse situations or unanticipated adverse gatherings. The vast majority of AEs reported On this research were being gentle or moderate in severity. The vast majority of SAEs were pulmonary and predicted events as Section of a lung resection medical procedures. Two patients died in the course of the course on the research, a person resulting from cardiac arrest and An additional due to multi-technique organ failure; neither have been product associated or unanticipated.nnThe particulars of such clinical trial adverse situations may be reviewed during the IFU equipped with the product an d also accessible at nnCaution: Federal (United states of america) regulation restricts this product to sale by or on purchase of a accredited medical doctor or thoroughly licensed practitioner." " id="text-76d961b47a" class="cmp-text"> 1. Allen, Mark S. et al, “Possible Randomized Analyze Evaluating a Biodegradable Polymeric Sealant for Sealing Intraoperative Air Leaks That Arise All through Pulmonary Resection” Annals of Thoracic Surgery 2004; seventy seven:1792-1801. Pivotal analyze. Details on file.
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