TransEnterix, Inc. (NYSE: TRXC) rose after the company disclosed that it has received the Food and Drug Administration clearance for expanded indications for its Senhance Surgical System.
The company, based in Research Triangle Park, North Carolina, is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery
It reported received FDA 510(k) clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System's total addressable annual procedures in the U.S. has more than doubled to over three million.
CEO Todd Pope declared, "This indication expansion immediately doubles the addressable market for Senhance in the US and validates our regulatory strategy to successfully add to our indications for use.
"These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice."
In the U.S., Senhance is now cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery. This enables Senhance to be used for some of the most common abdominal surgeries, including procedures in general surgery and gynecology.
The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics.
Its shares hurtled 24 cents, or 7.5%, to $3.37
