An atrial septal defect (ASD) is a congenital heart defect that can occur when the septum, the wall that separates the left and right atria, does not form or close properly.
Atrial Septal Defects
Atrial Septal Defects
Commonly referred to as “hole in the heart”, an ASD causes oxygen-rich blood to mix in the oxygen-poor chamber, which would not otherwise occur. This increases blood flow to the lungs and over time, may lead to high blood pressure, arrhythmia, heart failure or an increased risk of stroke 1 https://www.cdc.gov/ncbddd/heartdefects/atrialseptaldefect.html
Current Challenges
Defects vary in size. Some may close on their own early in life, while others require an intervention. Today, the vast majority are performed through minimally invasive catheter-based interventions. They consist in implanting an atrial septal occluder through a transcatheter procedure to close the defect.
Current ASD occluder devices have dense metal frames that permanently clamp the septum. The long-term presence of metal in the heart may lead to potential complications and may limit future interventions that require crossing the interatrial septum.
The reSept™ ASD Occluder
The Best Device is Less Device.
The reSept ASD Occluder is the first occluder with a metal-free, bioresorbable frame designed for the closure of atrial septal defects.
EFFECTIVE CLOSURE WITH
METAL-FREE FRAME
Aims to provide complete ASD closure and a minimal long-term device footprint.
RESTORES A MORE
NATURAL SEPTUM*
Flat septal profile with no protruding elements and resorption timed with healing offer the potential to preserve future treatment options.
PHYSICIAN CONTROL
STABILITY
Versatility to adapt to anatomy with an over-the wire delivery that enables device repositioning needed.
How it Works
Delivered through a 12F sheath and over a standard guidewire, the low-profile device features bioresorbable filaments connecting two polyester fabric patches, which contain radiopaque markers.
The device is fully deployed with the guidewire in place, providing the opportunity to reattach and reposition when necessary.
After endothelialization, the filaments slowly resorb, with complete resorption demonstrated in-vitro at 24 months. The polyester fabric and the radiopaque markers remain, which may be useful for future transseptal procedure planning. Available in three sizes, the device supports closure of defects from 8-22mm.
Locking Mechanism
Fabric Patch
Bioresorbable Filaments
Fabric Patch
Locking Mechanism