TransEnterix Receives FDA Clearance for Senhance Surgical System


On Tuesday it was announced that the North Carolina-based medical instruments company TransEnterix (NYSE:TRXC) had received clearance from the US Food and Drug Administration (FDA) for expanding indications of the company’s Senhance Surgical System.

The Senhance Surgical System is meant to help improve invasive surgeries, as the company has now received FDA 510(k) clearance for laparoscopic inguinal hernia surgery and the gallbladder removal surgery due to laparoscopic cholecystectomy.

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According to TransEnterix, there are nearly “760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S.” and the clearance that the company has received will also help to increase the total number of procedures that are able to be done with the Senhance Surgical System.

TransEnterix President and CEO, Todd M. Pope, has said that “this indication expansion immediately doubles the addressable market for Senhance in the US and validates [the company’s] regulatory strategy to successfully add to [their] indications for use.” 

The Senhance Surgical System has now been approved for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery in the US.

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According to the Chief of Surgery at St. Marien Hospital in Siegen, Germany, Frank Willeke, they “believe this procedural expansion for the US will allow surgeons there to incorporate the Senhance…as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.”

Shares of TransEnterix have risen nearly ten percent since the announcement was made on Tuesday. As of 3:36 pm EDT, the company had reached a share value of $3.45 USD and had already reached a high share value of $3.88 and a low of $3.33.

Comparatively, the company closed at a share value of $3.13 on Friday.

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About the author: Nicky graduated with a BA in Journalism and a Minor in English from Kwantlen Polytechnic University. She has written on a variety of different topics including fashion, beauty, entertainment and finance. Her favourite things to do are travel (when she can) and to spend time with friends and family, including her dog Kobe.