1. Lackey A, Mitchell JD. The cost of air leaks: physicians’ and patients’ perspectives. Thorac Surg Clin. 2010;20:407-411. 2. Seely AJ, Ivanovic J, Threader J, et al. Systematic classification of morbidity and mortality after thoracic surgery. Ann Thorac Surg. 2010;90:936-942; discussion 942. 3. Elsayed H, McShane J, Shackcloth M. Air leaks following pulmonary resection of lung cancer: is it a patient or surgeon related problem? Ann R Coll Surg Engl. 2012;94:422-427. 4. Liang S, Ivanovic J, Gilbert S. Quantifying the incidence and impact of postoperative prolonged alveolar air leak after pulmonary resection. J Thorac Cardiovasc Surg. 2013;145:948-954. 5. Okereke I, Murthy SC, Alster JM, et al. Characterization and importance of air leak after lobectomy. Ann Thorac Surg. 2005;79:1167-1173. 6. Varela G, Jimenez MF, Novoa N, et al. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005;27:329-333. 7. Mueller MR, Marzluf BA. The anticipation and management of air leaks and residual spaces post lung resection. J Thorac Dis. 2014;6:271-284. 8. Brunelli A, Xiume F, Al Refai M, et al. Air leaks after lobectomy increase the risk of empyema but not of cardiopulmonary complications: a case-matched analysis. Chest. 2006;130:1150-1156. 9. Billé A, Borasio P, Gisabella M, et al. Air leaks following pulmonary resection for malignancy: risk factors, qualitative and quantitative analysis. Interact Cardiovasc Thorac Surg. 2011;13:11-15; 897-898. 10. Liberman M, Muzikansky A, Wright CD, et al. Incidence and risk factors of persistent air leak after major pulmonary resection and use of chemical pleurodesis. Ann Thorac Surg. 2010;89:891-897; discussion. 11. Gómez-Caro A, Calvo MJ, Lanzas JT, et al. The approach of fused fissures with fissureless technique decreases the incidence of persistent air leak after lobectomy. Eur J Cardiothorac Surg. 2007;31:203-208. 12. Nagel MP, Gemmen E, Smith BF, et al. Assessment of the clinical and economic impact of air leaks during post-operative pulmonary surgery. Poster presented at the 13th European Congress of ISPOR. November 6-9, 2010; Prague, Czech Republic. 13. Swanson S, Miller D, McKenna R, et al. Economic burden of prolonged air leak after lung resection: open versus video-assisted thorascopic surgery (VATS). Value in Health. 2014;17:A80. 14. Hunt B, Aye R. Prolonged air leak after lung resection. Curr Respir Med Rev. 2012;8:280-284. 15. Brunelli A, Cassivi SD, Halgren L. Risk factors for prolonged air leak after pulmonary resection. Thorac Surg Clin. 2010;20:359-364. 16. Cerfolio RJ, Bass CS, Pask AH, et al. Predictors and treatment of persistent air leaks. Ann Thorac Surg. 2002;73:1727-1730; discussion 1730-1731. 17. Brunelli A, Monteverde M, Borri A, et al. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg. 2004;77:1205-1210. 18. Petrella F, Rizzo S, Radice D, et al. Predicting prolonged air leak after standard pulmonary lobectomy: computed tomography assessment and risk factors stratification. Surgeon. 2011;9:72-77. 19. Jiang L, Jiang G, Zhu Y, et al. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014;97:1008-1013. 20. Rivera C, Bernard A, Falcoz PE. Characterization and prediction of prolonged air leak after pulmonary resection: a nationwide study setting up the index of prolonged air leak. Ann Thorac Surg. 2011;92:1062-1068; discussion 1068. 21. Iyer A, Yadav S. Postoperative care and complications after thoracic surgery. Chapter 3. IntechOpen. Firsetenberg M, ed. doi: 10.5772/55351. Available at: https://www.intechopen. com/books/principles-and-practice-ofcardiothoracicsurgery/ postoperative-care-and-complications-afterthoracic-surgery. Published June 12, 2013. Accessed September 17, 2018. 22. C. R. Bard (Bard has joined BD). Physician survey 2014. Data on file. 23. Merritt RE, Singhal S, Shrager JB. Evidence-based suggestions for management of air leaks. Thorac Surg Clin. 2010;20:435-448. 24. Malapert G, Hanna HA, Pages PB, et al. Surgical sealant for the prevention of prolonged air leak after lung resection: meta-analysis. Ann Thorac Surg. 2010;90:1779-1785. 25. Belda-Sanchis J, Serra-Mitjans M, Iglesias Sentis M, et al. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev. 2010; CD003051. 26. Tambiah J, Rawlins R, Robb D, et al. Can tissue adhesives and glues significantly reduce the incidence and length of postoperative air leaks in patients having lung resections? Interact Cardiovasc Thorac Surg. 2007;6:529-533. 27. Okereke I, Murthy SC, Alster JM, et al. Characterization and importance of air leak after lobectomy. Ann Thorac Surg. 2005;79:1167-1173. 28. Merritt RE, Singhal S, Shrager JB. Evidence-based suggestions for management of air leaks. Thorac Surg Clin. 2010;20:435-448. 29. Allen MS, Wood DE, Hawkinson RW, et al. Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection. Ann Thorac Surg. 2004;77:1792-1801. 30. Burt BM, Shrager JB. Prevention and management of postoperative air leaks. Ann Cardiothoac Surg. 2014;3:216-218. 31. C. R. Bard (Bard has joined BD). Minimally invasive Progel trial; 2014. Data on file. 32. Progel Pleural Air Leak Sealant Instructions for Use. Morristown, NJ: C. R. Bard, Inc (Bard has joined BD); 2014. 33. Klijian A. A novel approach to control air leaks in complex lung surgery: a retrospective review. J Cardiothorac Surg. 2012;7:49. 34. Swanson SJ, Meyers BF, Gunnarsson CL, et al. Video-assisted thoracoscopic lobectomy is less costly and morbid than open lobectomy: a retrospective multiinstitutional database analysis. Ann Thorac Surg. 2012;93:1027-1032. 35. Fuller, Clark. Reduction of intraoperative air leaks with Progel in pulmonary resection: a comprehensive review. Journal of Cardiothoracic Surgery. 2013;8:90.

Indications. Progel™ Pleural Air Leak Sealant is a single-use device intended for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma. Contraindications. Do not use Progel™ PALS in patients who have a history of an allergic reaction to human serum albumin or other device components. Do not use Progel™ PALS in patients who may have insufficient renal capacity for clearance of the Progel™ PALS polyethylene glycol load. Do not apply Progel™ PALS on open or closed defects of main stem or lobar bronchi due to a possible increase in the incidence of bronchopleural fistulae, including patients undergoing pneumonectomy, any sleeve resection or bronchoplasty. Warnings. Do not apply Progel™ PALS on oxidized regenerated cellulose, absorbable gelatin sponges, or any other surface other than visceral pleura, as adherence and intended outcome may be compromised. Adverse events. In a pivotal clinical trial, there were three patients in the Progel™ PALS group with adverse events that were considered by the investigator to be possibly or probably related to the device. The adverse events reported were: chest pain, constipation, gastroesophageal reflux, nausea, cough, dyspnea, pneumothorax, and subcutaneous emphysema. All were reported as a single occurrence in the Progel™ PALS group. Two of the adverse events, dyspnea and chest pain, were reported as “severe” and “serious,” respectively, and occurred in the same patient. All others were reported as mild or moderate. There were also reports of renal dysfunction, urinary system disorders, and deaths within the study population. None of these have been confirmed to be associated with Progel™ PALS. In a subsequent minimally invasive clinical trial, there were no device-related adverse events or unanticipated adverse events. The majority of adverse events reported in this study were mild or moderate in severity. The majority of serious adverse events were pulmonary and expected events as part of a lung resection surgery. Two patients died during the course of the study, one due to cardiac arrest and another due to multi-system organ failure; neither was device-related or unanticipated. The details of these clinical trial adverse events can be reviewed in the Instructions for Use supplied with the product and are also available at bd.com.

See full product labeling for complete Instructions For Use and important safety information.


BD-27040