Computer Motion's submission to the FDA provided results from two prospective randomised clinical studies. Clinical trials began on September 22, 2001, and ended on December 31, 2001. The studies intend to demonstrate the safety and effectiveness of the ZEUS MicroWrist system for use in laparoscopic surgical procedures such as cholecystectomy and Nissen fundoplication.
"Adhering to our planned regulatory path and associated timetables is a central focus for the company. We are very pleased by the quality of the data we have submitted", stated David Munjal, Ph.D., Vice President of Clinical Affairs, Regulatory Affairs, and Quality Assurance for Computer Motion. "We expect to hear from the FDA within the normal response cycle of ninety days and hope that the clearance will be provided soon thereafter", continued Dr. Munjal.
A granted FDA clearance would expand the company's ability to market and sell the ZEUS MicroWrist system for laparoscopic surgical procedures in the United States. Bob Duggan, Chairman and CEO of Computer Motion, commented: "This submission is another significant milestone for Computer Motion, and an imperative step towards full clearance of the ZEUS MicroWrist system. We expect the submission and subsequent regulatory clearance will have a positive effect on our sales efforts in this calendar year."
Integrated Surgical Systems designs, manufactures, sells, and services image-directed, computer controlled robotic products for use in orthopaedic and neurosurgical procedures. The ROBODOC Surgical Assistant System is a specific robotic system for hip and knee replacement surgery. NeuroMate, the neurosurgery system, is the first robotic technology based system for use in stereotactic brain surgery.
Commenting on the agreement with Stryker, Dr. Ramesh Trivedi, President and CEO of Integrated Surgical Systems, stated: "The Stryker Corporation is one of the world's leading suppliers of orthopaedic products. ISS already provides software for six Stryker hip and knee prostheses and this additional software will offer orthopaedic surgeons another option to help ensure an optimal implant for their patients." While the agreement is with Stryker in Japan, the software will be made available worldwide.
More details on Computer Motion's MicroWrist technology are available in the VMW August 2001 article Computer Motion to enhance ZEUS Robotic Surgical System with MicroWrist technology. Additional news on Integrated Surgical's ROBODOC system can be found in the VMW June 2001 article Rotenburger Hospital in Germany readily switches from CASPAR to ROBODOC surgical assistant.