VENTURA Hydrocephalus Implant Valve

  • Modèle / numéro de série
  • Description du dispositif
    Valves for hydrocephalus are implant devices used in the surgical treatment of hydrocephalus, to derive the CSF (cerebrospinal fluid) from the ventricles into the peritoneal cavity or to other drainage sites appropriate for a particular patient. Sondispositives produced in medical grade silicones and material-thermoplastic with unrestricted implantability, intended for use in patients with hydrocephalus. The external ventricular drainage catheter with anti-siphon mechanism (CSF "cerebrospinal fluid" / MAS "anti-siphon mechanism") is indicated in temporary relief of intracranial hypertension for any etiology that causes a disturbance in the absorption of the flow of CLL, whether in subarachnoid hemorrhages, interventricular, hydrocephalus, and primary brain tumors. The anti-siphon mechanism has an internal design, which allows the LCR to flow inside without offering additional resistance to the drainage system, and when a negative pressure occurs in the distal part of the system (fall of the bag to the floor, for example), the The anti-siphon mechanism is activated and blocks the sudden emptying of the cerebral ventricles. The external drainage systems are used to drain the cerebrospinal fluid (produced inside the cerebral ventricles) into a collecting container located externally of the human body. These systems are relatively widely used in neurosurgical procedures and, in general, are composed of a
  • Manufacturer
  • 1 Event


  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source