TransEnterix Announces FDA 510(k) Submission for 3mm Senhance Instruments
Filed 510(k) submission for 3mm Instruments, advancing minimally invasive capabilities within digital laparoscopy
The clearance of these instruments would allow the Senhance to be used for microlaparoscopic surgeries, allowing surgeons to make tiny incisions that are deemed virtually scarless for patients.
“TransEnterix is the first company to seek
"Microlaparoscopy is the current frontier in the process of reducing
invasiveness, pain, scarring and opioid use post-surgery," said Dr.
In the U.S., Senhance is cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery, enabling Senhance to be used in over 3 million procedures per year, including some of the most common abdominal surgeries in general surgery and gynecology.
This press release includes statements relating to the Senhance Surgical
System and our current regulatory and commercialization plans for this
product. 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 and include whether use of the 3 millimeter instruments
will enable surgeons to expand their use of virtually scarless surgery
in more patients, and expand the value that robotics can bring over
traditional manual approaches. For a discussion of the risks and
uncertainties associated with