Integrated Surgical Systems Inc.
Integrated Surgical Systems Inc. (ISS) was one of the earliest companies in the field of surgical robotics, founded in 1990 in Sacramento, California. It has developed two image-directed, semiautonomous robotic products for neurological and orthopedic surgical applications.
The ROBODOC Surgical Assistant System was developed together with IBM T. J. Watson Center. A 5 degree of freedom (DOF) IBM SCARA robot (manufactured by Sankyo Seiki) was custom designed for total hip arthroplasty - THA (surgical shaping or alteration of the joint). The system consists of a robotic arm assembly and a PC-based 3-D planning station called Orthodoc.
The Orthodoc together with the Robodoc use pre-surgical images and software to first design the surgical procedure. Surgeon can precisely define the cavity in the hip bone, size and position the prosthesis before the real surgery. Robodoc cuts the patient without direct human control of the cutting tool during the procedure. The computer aided design of the surgery results in cleanly cut cavity, accuracy, precise fit of the prosthesis and long lasting hips joints compared to the traditional methods.
The more than 50 units sold had been used in 8000 arthroplasty procedures worldwide (including hip and knee) in the 90s, and almost 20 000 in the last couple of years. In 2000, formal clinical trials for US Food and Drug Administration’s (FDA) clearance began for premarket notification 510(k) . It targeted the approval for THA procedures with the use of VerSys line of cementless hip prostheses made by Zimmer (Warsaw, IN). Unfortunately, ISS did not make it to the end of the procedures (see next post). It ceased operations in mid-2005 because of lawsuits and lack of funding, and sold Robodoc assets to Novatrix Biomedical in 2007. Using those assets, Novatrix has set up Curexo Medical Co. to continue development of Robodoc Robodoc is now sold by ROBODOC, a CUREXO Technology Co.
In 1997 ISS. purchased Innovative Medical Machines Int. (MMI, Lyon, France) to acquire the NeuroMate neurosurgery system developed at the Grenoble University based on an AID industrial manipulator. The 5 DOF NeuroMate’s controller was re-designed, and used for surgical assistance for biopsy and tumor removal. In stereotatic neurosurgery, instead of pre-operative images, the NeuroMate system provided real-time 3D images to give surgeon precise location of a tumor. This was the first neurosurgical robotic device to get CE mark in Europe, and then the FDA approval in 1997 for stereotactic neurosurgical procedures. It also has an approval for neuro-endoscopic applications and for frameless stereotactic surgery in 1999.
In the first couple of years the company has installed around 20 NeuroMate systems in the United States, Europe and Japan, and the system has been used in 8000 stereotactic brain surgeries. The system and the frameless device were sold together for about $400,000.
ISS ceased operations in mid-2005 because of lawsuits and lack of funding, and it sold its Robodoc assets to Novatrix Biomedical in 2007. Using those assets, Novatrix has set up a new company called Curexo Medical to continue development of Robodoc, which is still sold in Europe, Asia, and other regions and finally received FDA approval in 2008. The NeuroMate technology was recently acquired by Schaerer Mayfield NeuroMate AG (Lyon, France), and it is currently not available on the market.
[Source: Old robodoc.com site]