According to Medtechdive.com, the U.S. Food and Drug Administration has approved an upgraded version of Monteris Medical’s NeuroBlate probe system. The device upgrade purportedly removes the risk of overheating. The overheating problem caused the FDA to issue a Class I recall due to the potential hazard to brain tissue. The FDA recall encompassed a device made by Medtronics as well.
The FDA recall concerns a magnetic resonance-guided laser interstitial thermal therapy device. Surgeons use the tool to ablate or kill tissue such as cancer. The FDA initiated that recall due to reports from physicians indicating that their patients suffered adverse outcomes after their procedures. The physicians determined that the device overheated and caused their patients to suffer health issues as a result.
The devices failed to capture temperature readings during surgical procedures. The FDA expressed disapproval over the current device because it failed to account for temperature increases in tissue surrounding the targeted tissue even as the affected tissue cools.
The devices, when working correctly, offer significant benefit to patients with complicated medical conditions like cancers, most notably brain cancer. The medical device comprises a laser probe that surgeons insert into the tumor and the laser heats and destroys the targeted tissue. The probe, meanwhile, records the temperature of the tissue. Physicians monitor the temperature immediately. The FDA said that the time it takes to read the temperature, and other factors can lead to inaccurate results.
Monteris repaired its device by replacing a thermocouple sensor made of metal with a non-metallic sensor that is a fiber optic device. The FDA approved the redesign. Healthcare professionals may contact the company to inquire about its availability. The FDA also cautions users about continuing to perform the procedure with the older device. Surgeons can continue to use the device as long as they follow prescribed safety procedures.
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