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Cardia

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.

Features

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.

Features

  • 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