Project example >> The Carag Bioresorbable Septal Occluder.
Advancing the technology of septal occlusion.
Transcatheter device closure of atrial level shunts is a standard of care throughout the world, and the treatment of choice for most patients. The Carag Bioresorbable Septal Occluder (CBSO) is a breakthrough device that advances septal occluder technology to a new level.
Current septal implants utilized a metal framework to support occlusive material and to 'grasp' the septum, holding the device in place. CBSO employs a device framework that 'goes away' after fulfilling its primary function following implantation.
Using a well described bioresorbable material with a significant history of human use, CBSO promotes excellent tissue response, and predictable resorption timelines. Based upon chronic animal studies, this major advance in framework technology is expected to provide key benefits for patients, including:
_Risks of thrombus, cardiac erosion and cardiac perforation associated with metal frameworks are eliminated
_Additional complications reported with metal framework devices such as atrial arrhythmias and distortion of the mitral valve annulus are significantly reduced
_(Future) access to the left atrium for additional procedures such as LAA occlusion, mitral valve repair, pulmonary vein ablation, etc is not impeded by the device framework
Simultaneously, the CBSO retains all clinical features that cardiologists require to achieve excellent outcomes, including:
_Self-centering for optimal positioning within the defect resulting in excellent defect closure rates
_Excellent conformability for a better 'fit' on the septum and a very flat profile post-delivery, leading to an optimal tissue response and excellent overall healing
_Optimal operator control. CBSO is fully retrievable and re-deployable, including after release from the delivery system. This means CBSO can be evaluated in its final septal configuration, and reattached, repositioned or replaced if needed - a major clinical advantage