ultrasept Patent Foramen Ovale (PFO) Closure

Ultrasept PFO's patented technology has been developed for permanent percutaneous closure of the Patent Foramen Ovale, while maximally respecting the anatomy of the heart.

Details of the product

Its structure has been designed with braided nitinol for better flexibility, in the form of a double disc covered by membranes.

Thanks to its light and flexible structure, it adapts to the cardiac anatomy as much as possible and maintains a series of advantages for the patient:

Indication for transseptal passage of material through the device in future procedures.
Adaptation to any septal anatomy, including septa with lipomatous hypertrophy.
Low rate of post-implant atrial fibrillation (AF).
Left disc with a completely flat and smooth surface, without exposure of any metallic element in the left atrium.

Available in four sizes that cover a wide range of anatomical measurements.

Details of the product

Membrane covered double disc PFO closure device.
Recoverable and repositionable.
Compatible with 9Fr, 10Fr and 11Fr release system.

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Technical Specifications

General Characteristics
Indication	Permanent closure of a patent foramen ovale
Available measurements (right disc diameter)	20, 25, 30, 35 mm
Self-expanding structure material	Nitinol and titanium
Right/left disc cover material	Polyester/PVA
Left disc / right disc diameter ratio	18 mm / 20 mm (measurement 20 mm) 20 mm / 25 mm (measurement 25 mm) 25 mm / 30 mm (measurement 30 mm) 30 mm / 35 mm (measurement 35 mm)
Radiopaque markers	Yes, platinum – iridium
System recovery and repositioning	Yes, possible before release

Order information

Reference ULTRASEPT PFO	Diameter Left atrium-Right atrium	Right disc diameter	release pod
SO-02-0020	18mm / 20mm	20 mm	10 Fr
SO-02-0025	20mm / 25mm	25 mm	10 Fr
SO-02-0030	25mm / 30mm	30 mm	10-11Fr
SO-02-0035	30mm / 35mm	35 mm	12 Fr

Reference Release System	Description	release pod
AC-10 0801	Kit standard 10 Fr	80 cm long. and ASD curve
AC-11 0801	Kit standard 11 Fr	80 cm long. and ASD curve
AC-12 0802	Kit standard 12 Fr	80 cm long. and ASD curve