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NeuroBlate System

NeuroBlate Timeline of Key Events

 

  • April 1, 2013 – FDA cleared the NeuroBlate System for use in the U.S.
    • It’s important to note that the NeuroBlate System was never approved by the FDA. Instead, it was merely “cleared” by the 510(k) process, meaning the FDA permitted Monteris to market the device because it was substantially equivalent to a device already on the market.
    • Therefore, Monteris never conducted any controlled clinical trials on the NeuroBlate System before putting it on the market.
  • October 5, 2017The NeuroBlate System is recalled due to unexpected heating of its laser probes. In some cases, the laser probes were interacting with the MRI system to cause unexpected heating, and consequently, unanticipated heating of surrounding brain tissue.
    • The FDA identified this as a Class I recall, the most serious type of recall, as the use of these devices could cause serious injuries or death.
    • FDA recommended health care providers should strongly consider treating patients using alternative procedures if available.
  • October, November, and December 2017 – Monteris issued “Advisory Notices” about the unintended heating of the laser probes.
    • These notices emphasized that Monteris was NOT requesting return of any product from the health care providers’ possession.
    • Instead, Monteris recommended physicians take certain precautionary steps to mitigate the risk to patients, including limiting MRI scans while the probe is in the patient. This effectively encouraged health care providers to continue using the NeuroBlate System, despite the Class I recall.
    • None of the three Advisory Notices issued by Monteris mention the Class I recall of the laser probes.
    • While these Advisory Notices can be found on Monteris’ website, there is no mention of the Class I recall on the company’s website.
  • March 22, 2018FDA issued a Safety Alert to health care providers warning them that the Advisory Notices issued by Monteris are not sufficient to mitigate the risk of unintended laser probe heating.
    • The Safety Alert noted that the unintended heating and damage to the probe appears to have been caused by an interaction between the thermocouple in the probe (which contained metal) and the MRI environment.
    • The Safety Alert stated the FDA had received medical device reports (MDRs) related to overheating of the probe, including one patient who experienced an intracranial hemorrhage and died.
    • The Safety Alert by the FDA reiterated that health care providers should strongly consider treating patients using alternative procedures if available.
  • April 24, 2018FDA issued a letter to health care providers warning that the MR thermometry, which is used to monitor the changes in temperature at the laser ablation site, was potentially inaccurate and may not account for continued spread of energy to the surrounding brain tissue.
    • The letter stated the FDA had received medical device reports (MDRs) and literature reports which describe the following adverse events when these devices were used to treat intra-cranial lesions: neurological deficits, increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes.
    • The FDA recommended that health care providers consider and discuss with your patients the benefits and risks of these devices, as well as the availability of any alternative treatment.
  • July 30, 2018Monteris submitted its application for FDA clearance of a new laser probe for its NeuroBlate System, which no longer contained a metal thermocouple.
  • October 15, 2018FDA cleared Monteris’ new laser probe for its NeuroBlate System. The new probe was called the NeuroBlate Optic Laser Probe.
    • The new design replaced the metal thermocouple inside the laser probe with a non-metallic fiber optic temperature sensor, thus eliminating any risk of unintended probe heating.
    • According to Monteris company officials, this change to the laser probe’s design raised the probe’s safety profile by preventing overheating targeted tissue.
  • November 8, 2018FDA issued a letter to healthcare providers alerting them that Monteris received FDA clearance for a new probe with a non-metallic thermocouple sensor.
    • The FDA made clear that the safety risks associated with the old probe containing the metallic thermocouple sensor still remain.

If you had “minimally-invasive” laser ablation surgery with the NeuroBlate System after October 5, 2017 (date of Class I recall) and before October 15, 2018 (date new probe was released) ask yourself the following:

  • Were you injured as a result of the surgery (e.g., brain bleed, edema, neurological deficits, visual changes, motor deficits)?
  • Did your doctor tell you the device was subject to a Class I recall?
  • Did you know that the NeuroBlate laser probe could cause unintended overheating of surrounding brain tissue?
  • Did you know FDA had received medical device reports (MDRs) related to overheating of the probe, including one patient who experienced an intracranial hemorrhage and died?

Even if you had surgery after October 15, 2018 (date new probe was released), it’s possible your doctor used the old probe that was subject to the Class I Recall. We can help you find out. Contact our firm today.

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