ORLANDO — Robot-assisted surgery is being applied to a widening range of procedures, thanks to more precise controls and growing awareness in the medical community of its benefits. AdventHealth for Women yesterday announced that it is the first health care system in Florida to use TransEnterix Inc.’s Senhance surgical system for minimally invasive gynecological procedures.
“With the Senhance Surgical System, we’re not only able to treat the condition, but also give patients the ability to recover faster and enjoy better quality of life,” said Dr. Steven McCarus, chief of the division of gynecologic surgery at AdventHealth for Women.
Morrisville, N.C.-based TransEnterix responded to the following questions from The Robot Report about its surgical robot and the additional procedures.
What specific gynecological procedures does TransEnterix’s Senhance Surgical System enable?
The Senhance Surgical System is FDA-cleared for the following gynecologic surgeries: total laparoscopic hysterectomy, radical hysterectomy, cystectomy, salpingectomy, oophorectomy, myomectomy, lymphadenectomy, endometrial resection, adnexectomy, omentectomy, parametrectomy, and lysis of adhesions.
What regulatory approvals were necessary?
In October 2017, TransEnterix received 510(k) clearance from the FDA for use of the Senhance in laparoscopic colorectal and gynecologic surgery. The current indications include laparoscopic colorectal, gynecologic, inguinal hernia, and cholecystectomy (gallbladder removal) surgery, which brings the total addressable annual procedures in the U.S. to over 3 million.
What feedback did AdventHealth provide to TransEnterix regarding using surgical robot for gynecological procedures?
The feedback received by TransEnterix from AdventHealth regarding use of the Senhance Surgical System has been very helpful, as the technology has developed further. Dr. McCarus at AdventHealth cited the improved ergonomics, small incisions, eye tracking, and haptic feedback as some of the advantages of the Senhance System. In particular, the surgeons at AdventHealth are expert laparoscopists, and this system builds on the approach and familiarity of those techniques.
How much shorter are recovery times from minimally invasive procedures versus traditional ones?
Data is still being collected to understand this issue over time. However, the ability to perform microlaparoscopic procedures using 3-millimeter instruments represents a welcome shift in the world of robotic surgery and a capability exclusive to the Senhance System. Previous robotic systems typically utilize 8mm instruments, which are actually larger than traditional laparoscopic instruments. The goal should be to take the incision size lower.
“Utilizing 3mm micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said McCarus, MD, FACOG. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”
Is the rate of complications less with Senhance than with non-assisted surgeries?
Such outcome data is still being collected to understand the impact over time. We offer specialized sensors to alert the surgeon if excess force is being placed on the patient’s body while operating to decrease patient trauma. The surgeon has control over their visualization and can use the haptics to feel if there is any conflict or contact with tissue outside their immediate field of view. The belief is that adding greater control of movement and vision while sensing forces in surgery may improve outcomes over time.
How much training did AdventHealth personnel require to be able to use Senhance?
The system is designed to be a laparoscopic surgical tool. A special multi-day training course and lab have been validated with a usability study that was submitted along with other data during the regulatory approval process. Surgeons at AdventHealth undergo this multi-day training, engage in additional lab work, and are proctored by expert surgeons with experience on the technology during their initial surgeries. The staff has specific training as well. The entire process typically takes a few weeks.
How many procedures have been done with the surgical robot so far? How many colorectal and gynecological surgeons are using it?
TransEnterix does not release detailed procedure and user numbers. But thousands of procedures have been done to date globally with the system. Several dozen sites, with multiple surgeons per site, have used the system.
Are there other minimally invasive surgeries for which Senhance could be used?
The Senhance Surgical System is the first new abdominal robotic platform to receive FDA clearance since 2000. The Senhance System can be used in more than 25 different procedures, including some of the most common abdominal surgeries such as procedures in general surgery and gynecology. Because Senhance is based on laparoscopic tools and techniques, this demonstrates the platform’s potential as a new surgical solution.
How many healthcare provides nationwide are using Senhance?
The system is currently only in a small number of leading healthcare centers in the U.S., as a newer technology. AdventHealth was actually the first clinical [facility] in the U.S. when it began in 2018.
Were there any challenges with getting robotically assisted procedures reimbursed by insurers?
Insurers pay for robot-assisted procedures using existing laparoscopic procedure codes. There is no additional reimbursement program for robotically-assisted procedures, which is why it is imperative for new technology to fit within the constraints of today’s value-based healthcare. Our goal with the design of the Senhance System is to keep the per-procedure costs similar to traditional laparoscopy, thereby eliminating that barrier.
What’s next for the AdventHealth team working with TransEnterix?
The system will continue to be utilized with more general surgeons and gynecologists. We look forward to expanding the clinical reach of this technology with AdventHealth for the benefit of their patients.