Table 3 Novel PFO closure technologies [3]
From: Patent foramen ovale closure review: decades of research and the evolution of the evidence
Novel devices and countries | Features |
|---|---|
A. Bio-absorbable devices | |
Biostar (Europe and Canada) First human trial done in the UK | The polyester material scaffold of the two discs in traditional devices is replaced with acellular collagen. |
BioTREKTM Still in preclinical phase | Fully bio-absorbable septal device. Less inflammatory and uses bioabsorbable poly-4-hydroxybutyrate polymers produced by recombinant DNA technology |
B. Intramural device | |
Coherex FlatStentTM EF (Coherex Medical Inc., UT, USA) Animal studies ongoing. | The intra-tunnel unit holds the septum primum and septum secundum together. Preserved septal anatomy. Low thrombosis risk. |
C. Single wire device | |
Nit-Occlud PFO device Available in Poland and the US | Reduced thrombosis Rapid endothelialisation. Pre-mounted, retrievable, and easy to use. Closure is effected by a synthetic patch on both atrial sides. |
D. ‘Device-less’ technologies | |
Noble Stitch (Noble’s Medical Technology, CA, USA) Reported experience in Italy and the US | Transcatheter suture technology. |
HeartStitchTM Used in US, approved in Europe | Sutures made of polypropylene and two needles that may be deployed separately |
PFxTM Closure device Available in Europe | Septum primum and secundum are apposed using radiofrequency. Real device-less technology. |
SeptRxTM Occluder (SeptRx, Inc., Fremont, California) First human trial in Germany | Ideal for long tunnel PFOs. Inserted within PFO tunnel. Brings both septum primum and septum secundum together. Correct placement can be verified with imaging as it is radioopaque. |