Health Canada approves BLEScath™ for use in Canada.Posted On: mai 3, 2022
Health Canada approves BLEScath™ for use in Canada.
BLEScath™ is intended for the administration of bovine lipid extract surfactant suspension (BLES®) using minimally invasive surfactant therapy (MIST) / less invasive surfactant administration (LISA) technique for rescue treatment of infants with Neonatal Respiratory Distress Syndrome (NRDS)2,3. BLEScath™ is a first-of-its-kind single-use, unique, intratracheal, thin catheter with an integrated stylet that is anchored and remains fixed in place.
BLES® is intended for neonates at ≥ 28 weeks and or ≥ 1000 grams who do not require intubation or mechanical ventilation and meet the criteria for surfactant administration (i.e., oxygenation requirement met)1.
1.BLES® Product Monograph, January 31, 2022.
2.BLEScath™ Instructions for Use (IFU) December 31, 2020.
3.Herting E, Härtel C, Göpel W. Less invasive surfactant administration. Current Opinion in Pediatrics.2020;32(2):228–34.