ASD/PFO occluder with metal free framework
The Carag Bioresorbable Septal Occluder (CBSO) is a breakthrough device that advances septal occluder technology to a new level.
CBSO is not currently available in the United States.
Metal free, fully bioresorbable PLGA framework
- Bioresorbable framework: Eliminates metal framework induced risks of erosion, perforation, valve distortion
- Preserves atrial septum for future transseptal access
- Predictable resorption timeline after endothelialisation
- Framework fully resorbed within 24 months
- No Nitinol, no nickel
- Mature tissue coverage after 3 months (see pictures below)
- Enables easy and accurate septal positioning
- Suitable for ASD and PFO closure
- 3 sizes suitable for ASD up to 25 mm / PFO up to 4 mm tunnel length
- Flat profile
Fully repositionable and redeployable
- Over-the-wire delivery technique
- Retrievable and redeployable at all stages of delivery
- Repositioning possible even after deployment
- Can deploy RA side before LA side
- Platinum-Iridium markers provide excellent x-ray visibility
- Proven visibility on echo
- MRI compatible ≤ 3 Tesla
The possibility of using resorbable devices that close the hole in the atrial septum, then disappear leaving no foreign body in the heart, may represent one of the major advances in transcatheter interventions.
Prof. Dr. Mario Carminati, Pediatric cardiologist, Milan
Bioresorbable devices are the definite future of treating congenital and structural heart disease. With the Carag Bioresorbable Septal Occluder (CBSO) we are opening this new clinical chapter and might treat atrial septal defects in patients of all ages with a new device, that is soft, thin and has no metal structure (e.g. nitinol wires). This might influence and improve long term performance of implants, especially in children.
Prof. Dr. Stephan Schubert, Pediatric Cardiologist and Interventionalist, Berlin