The fallopian tube reconnection procedure, referred to as tubal reanastomosis, was performed by Dr. Tommaso Falcone, who is head of the Reproductive Endocrinology and Infertility Section at the Cleveland Clinic, situated in the city of the same name. Dr. Falcone used Computer Motion's ZEUS robotic surgical system as part of a clinical trial, approved by the United States Food and Drug Administration (FDA).
The patient, a 38-year-old woman, and her healthy 10-day-old son are both in excellent condition and have returned to their Cleveland-area home. The mother had originally undergone a tubal ligation sterilization operation in her twenties. She and her partner later wished to have a child together and began preparing for a reversal operation. The patient saw an advertisement for the ZEUS study and consulted with trial leader Dr. Falcone. The lady was informed in detail of the investigational protocol and agreed to have the robotically assisted procedure.
A traditional tubal reanastomosis procedure is typically performed through a large surgical incision. However, the ZEUS System enabled this operation to be performed fully endoscopically through a few incisions, each smaller than the diameter of a pencil. The main benefits of having the sterilization reversal procedure performed with ZEUS constitute the minimal invasion of the body through significantly smaller incisions and shorter recovery periods, as well as less pain and scarring.
Dr. Falcone stated that the ZEUS System has allowed the surgical team to perform the delicate reconnection of the fallopian tubes with a high level of confidence, effectiveness and safety. All 10 trial patients now have the ability to conceive, with four pregnancies to date. The surgeons at Cleveland Clinic are excited to offer a minimally invasive surgical option to more women and look forward to continued positive outcomes. Dr. Falcone thinks that robotic surgery will make a large impact in the way surgery will be performed.
One of the truly gratifying aspects of Computer Motion's leadership work in medical robotics is the ability to play a key role in both saving and creating new lives, according to Robert W. Duggan, who is the company's chairman and chief executive officer. Computer Motion congratulates Dr. Falcone and his patient on the successful delivery of a healthy baby boy. Based on the safety and efficacy demonstrated in the clinical trials, the FDA has approved an extension for Cleveland Clinic to perform yet another twenty robotically assisted tubal reanastomoses.
Yulun Wang, Ph.D., founder and chief technical officer of Computer Motion, commented that the company has been pursuing clinical applications in a step-wise fashion to maximise patient safety, Operating Room-readiness and clinical utility of the ZEUS technology platform. The Computer Motion team is pleased with the FDA's approval for the Cleveland Clinic extension and looks forward to demonstrating additional applications of the ZEUS System.
Dr. Yulun Wang states that for the next twenty planned cases, ZEUS will be utilised throughout the procedure for cutting and dissecting, in addition to reconnecting the sterilized fallopian tubes. Computer Motion is creating the cornerstone technologies and products for tomorrow's Intelligent Operating Room. The company is a specialist in developing, manufacturing as well as marketing proprietary computer-enhanced and robotic surgical systems that optimise the surgeons' capabilities, improve outcomes and reduce costs.
In addition to the ZEUS System, Computer Motion markets the AESOP 3000, a voice-controlled endoscope positioning system, and the HERMES Control Center, a centralised system which enables the surgeon to voice control a network of "smart" medical devices. Currently, the ZEUS System is under an FDA-approved investigational device exemption and is also CE marked for commercial sale in Europe. ZEUS is co-marketed by Computer Motion and Medtronic. You can consult this year's VMW March article New patent to protect robotically enhanced surgery in the operating theatre for more details on the ZEUS robotic surgical system.