Baxter Healthcare Ltd today announced the CE marking and European market launch of a thoracic lung sealing indication for its COSEAL Surgical Sealant. The new indication is for reinforcing sutures and staple lines in lung resection procedures. The value in sealing suture lines during lung resection surgery is the potential to prevent air leaks and subsequently to reduce chest tube removal times, hospitalisation times, and potentially morbidity rates.
COSEAL was previously only indicated for anastomotic sealing during cardiovascular procedures and for the reduction in post-surgical cardiac adhesion formation. Its characteristics include ease of use with a sprayable delivery for easy application to resection suture lines, high elasticity for conformity to expanding lung tissue, and a good safety profile.
“Postoperative air leak from the sutured or stapled surface of lung resections is a frequent complication that may prolong the need for chest tube and hospitalization. COSEAL, designed to provide the surgeon with a material that can be easily applied, enforce the staple or suture lines after lung resection procedures, mechanically sealing the area of leakage and thus meeting this medical need” said Bernard Chéru, MD, Director BioSurgery Europe.
Baxter will immediately begin marketing the new indication throughout Europe and other international markets that recognize the CE marking. Clinical trial data from a prospective randomised study to evaluate the efficacy and safety of COSEAL to reduce air leaks and to improve postoperative outcomes in patients undergoing lung resection was presented at the 22nd Meeting of the European Association for Cardio-Thoracic Surgery on 16 September 2008.