Wednesday, December 12, 2007

Anesthesia without any type of medication?


A company called BioMeDevice Ltd has developed and received FDA approval for a device that basically provides anesthesia through the use of a compound that gets very cold. An interesting idea.

From the company:
Oral pain relief in seconds without drugs? The FDA says yes, recently certifying the first cryoanesthetic dental mouthpiece for the US OTC market. The new gumEase provides pain relief without the side effects or complications of drugs. It's a tempting solution for clinicians plagued with patient needle phobia, sharps and the complex issues of hypodermic delivery.

A YouTube video by Dr. Deborah Ayala, president of the Latin American Institute of Dentistry, performs an extraction without anesthesia - just two chilled, disposable gumEase mouthpieces. The patient reports no pain during the procedure. http://www.youtube.com/watch?v=H6vzdrdr9S8

Inserted easily into the upper and lower sulci, the latex-free device delivers a soothing, cool temperature to the maxillofacial nerves, quickly diminishing pain across a wide area of the mouth. In patient tests the new gumEase diminished pain by 90% in 2 to 3 minutes for the average participant. Patients can also apply them post-operatively as needed, and reuse without side effects by storing in a household freezer.

"It gives dentists an option they didn't have before", says Tay McClellan, BioMeDevice CTO, "they can manage patient pain easily in a wider range of situations. Now it's not a problem to have a patient who can't use drug-based anesthesia." The device also holds promise for situations where needle use is limited; such as Brazil, whose interest in the gumEase is spurred by HIV initiatives there.

The Class 2 gumEase G-100 is prepared by storing in a conventional freezer until freezing temperature is reached. Proprietary solutions inside the mouthpiece prevent it from freezing, allowing it to form comfortably within the patient's mouth for several minutes. Pain reduction lasts for up to twenty minutes, and the process can be repeated as often as needed.

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