TransEnterix, Inc., a medical device company that is pioneering the use of flexible instruments and robotics to improve minimally invasive surgery, today announced the first human cases performed using its recently launched fully flexible advanced energy device.
The Flex Ligating Shears, which has received 510(k) clearance from the U.S. Food and Drug Administration, is designed to deliver full flexibility to the surgeon while offering ligation and division with direct thermal energy in various laparoscopic surgical procedures.
“TransEnterix now offers the only advanced energy device that completely articulates 360 degrees to provide optimal access to surgeons within the operating field, while competing technologies offer limited or no articulation,” said Todd M. Pope, President and CEO of TransEnterix. “With the SPIDER Flex Ligating Shears, we can offer surgeons the ability to attain precise angles when cutting and dividing tissue in a laparoscopic procedure.”
Advanced energy devices represent one of the most versatile and critical tools for surgeons in minimally invasive surgery. These devices deliver controlled energy to effectively ligate and divide tissue while greatly limiting bleeding in the operative field and minimizing thermal injury to surrounding structures.
Dr. Andrew Hargroder, a general and bariatric surgeon in Baton Rouge, Louisiana, was the first surgeon to utilize the new device for sleeve gastrectomy procedures. “The SPIDER Flex Ligating Shears offered me a fast and simple way to cut and seal tissue,” said Dr. Hargroder. “The device created no plume to impair visualization, sealed tissue extremely well, and appeared to minimize thermal spread. With 360 degrees of angulation, this device reaches areas where rigid instruments may have difficulty.”
TransEnterix’s advanced energy device has been created for surgeons to use with the company’s existing SPIDER Surgical System. The company intends to offer a similar device in the future for its SurgiBotTM system, a new patient-side robotic surgery system currently under development.
TransEnterix (transenterix.com) is a medical device company that is pioneering the use of flexible instruments and robotics to improve minimally invasive surgery. The company is focused on the development and commercialization of the SurgiBot™ system, a minimally invasive surgical robotic system that allows the surgeon to be patient-side within the sterile field.
Forward Looking Statements
This press release includes statements relating to our advanced energy device and SurgiBot system, as well as our current regulatory and commercialization plans for the system. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include but are not limited to: the pace of adoption of our product technology by surgeons, including the Flex Ligating Shears Advanced Energy Device; whether the SPIDER Flex Ligating Shears can offer surgeons the ability to attain precise angles when cutting and dividing tissue in a laparoscopic procedure; the success and market opportunity of our continuing and new product development efforts, including the SurgiBot system; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with TransEnterix's business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended Dec. 31, 2013; and subsequent SEC reports. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact: Mark Klausner, Westwicke Partners
P: 443-213-0501 - E: transenterix[.]westwicke.com.