First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

March 1, 2021

First robotically-assisted surgical device that can help facilitate transvaginal hysterectomy in certain patients has received FDA approval.

The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).

“We are providing physicians and patients another minimally-invasive gynecologic surgical option for non-cancerous conditions,” said Binita Ashar, M.D., MBA, FACS, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures.”

RASD, sometimes referred to as robotic surgical devices or computer-assisted surgical devices, are not actually robots. The devices cannot perform surgery without direct human control. RASD enable a surgeon to use computer and software technology to control and move surgical instruments through one or more tiny ports (incisions or orifices) in the patient’s body and in a variety of surgical procedures or operations. RASD technology facilitates performing minimally-invasive surgery and complex tasks in confined areas inside the body.

To remove the uterus, the Hominis Surgical System uses minimally-invasive surgical instruments inserted through the vagina (transvaginal approach) and a video camera inserted laparoscopically through a small incision on the abdomen for visualization of the instruments inside the patient. The transvaginal approach requires fewer incisions on the abdomen compared to conventional laparoscopic hysterectomy. During the procedure, surgeons in the operating room control the instruments from the Hominis Surgical System console. The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device.

In addition to its assessment of performance and engineering testing, the FDA evaluated safety and effectiveness in a clinical study of 30 patients undergoing transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions, using the Hominis Surgical System.

Patients had varying characteristics such as ages ranging from 37 to 79 years, body mass index from 17.6–40, and 63% of patients had different comorbidities, such as high cholesterol, osteoporosis or high blood pressure. All 30 procedures with the Hominis Surgical System were successfully completed and there were no conversions to an open or other laparoscopic surgical approach.

Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

The FDA granted marketing authorization of the Hominis Surgical System to Memic Innovative Surgery Ltd.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.