Encision Inc. Applauds the FDA's Safety Communication On The Dangers Of Monopolar Electrosurgery

Thursday, May 31, 2018 Drug News
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Encision's AEMŪ Technology Is The Solution That Eliminates The Dangers

BOULDER, Colo., May 31, 2018 /PRNewswire/ -- Encision Inc. (OTC:ECIA), a medical device company owning patented surgical

technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today applauded the FDA's issuance of a safety communication, "Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication" that describes the dangers of monopolar electrosurgery and the means to mitigate or eliminate this risk.

The Safety Communication was released by the FDA on May 29, 2018 and it may be found on the FDA's website at:  https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm608637.htm.

The Safety Communication states that,

  • "In addition to serving as an ignition source, monopolar energy use can directly result in unintended patient burns from capacitive coupling and intra-operative insulation failure. If a monopolar electrosurgical units (ESU) is used: 
    • Do not activate when near or in contact with other instruments."

"Optimizing surgical outcomes and eliminating the sources of potential surgical risk to patients are the primary objectives for all involved in medical devices and surgical care," said Gregory Trudel, President and CEO of Encision. "We are encouraged by the FDA's recent safety communication that focuses on the significant patient risks of capacitive coupling and intra-operative insulation failure during standard or robotic laparoscopic surgery. We applaud the FDA's initiatives to safeguard the public from these potentially deadly sources of patient injury and we promise to complement their efforts by providing accredited continuing education and technical solutions to surgical providers. To the best of our knowledge, AEMŪ Technology is the only technical solution to this issue."

Encision Inc. designs and markets a portfolio of high performance surgical instrumentation that delivers advances in patient safety with AEM technology, surgical performance, and value to hospitals across a broad range of minimally invasive surgical procedures. Based in Boulder, Colorado, the company pioneered the development and deployment of Active Electrode Monitoring, AEM technology, to eliminate dangerous stray energy burns during minimally invasive procedures. For additional information about all our products, please visit www.encision.com.

In accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, the Company notes that statements in this press release and elsewhere that look forward in time, which include everything other than historical information, involve risks and uncertainties that may cause actual results to differ materially from those indicated by the forward-looking statements. Factors that could cause the Company's actual results to differ materially include, among others, its ability to develop new or enhanced products and have such products accepted in the market, its ability to increase net sales through the Company's distribution channels, its ability to compete successfully against other manufacturers of surgical instruments, insufficient quantity of new account conversions, insufficient cash to fund operations, delay in developing new products and receiving FDA approval for such new products and other factors discussed in the Company's filings with the Securities and Exchange Commission. Readers are encouraged to review the risk factors and other disclosures appearing in the Company's Annual Report on Form 10-K for the year ended March 31, 2017 and subsequent filings with the Securities and Exchange Commission. We do not undertake any obligation to update publicly any forward-looking statements, whether as a result of the receipt of new information, future events, or otherwise.

CONTACT: Mala Ray, Encision Inc., 303-444-2600, mray@encision.com

 

Cision View original content:http://www.prnewswire.com/news-releases/encision-inc-applauds-the-fdas-safety-communication-on-the-dangers-of-monopolar-electrosurgery-300657024.html

SOURCE Encision Inc.



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