KB Medical receives CE Mark for its Robotic Assistance System
6-13-2016
The company has developed a hardware and software robotic platform which enables unique intra-operative haptic steering capability. The technology platform has the accuracy required for brain surgery, the reach to address full spinal surgery, and the strength necessary for orthopedic applications: from head to toe, all with one device. The company’s first system, which is now CE certified, is targeting a clear unmet medical need in spinal surgery: to provide the additional stability and accuracy to perform mini-invasive procedures.
Says Dr. Marc Morard, MD, Head of the Unit of Neurosurgery, Hôpital du Valais, Sion, Switzerland: “I had the opportunity to use the AQrate System during a clinical trial for spinal surgery on over twenty patients. The product’s ability to maintain uncompromised trajectories has proven very effective, in particular in mini-invasive approaches. This is clearly a technology whose potential will shape the future of spinal surgery”.
Dr. John M. Duff, MD, Neurosurgeon at the University Hospital in Lausanne (CHUV), Switzerland, to add: “I have been expecting such a system for a long time, and am very happy to see the AQrate System now being CE marked. I am looking forward to the opportunity of using this system in my surgical practice, in particular for cervical surgery”.
Dr. Chetan Patel, MD, Medical Director of the Spine Health Institute in Altamonte Springs, Florida, an internationally renowned spine surgeon expert in minimally invasive back and neck surgery, has also been using the AQrate System during clinical trial in Switzerland. “The system delivered on all of our expectations – it performed flawlessly,” he says. “It was the defining moment of my career thus far. To have the opportunity to take something like this from the raw prototype to the point at which we’re actually using it in a patient and proving its capabilities – it just doesn’t happen that way very often.”
Says Jean-Marc Wismer, CEO of KB Medical: “This CE certification is a significant milestone in the development of the company; KB Medical is now working towards clearing this device with the FDA for USA market. Our next step is to finalize strategic partnerships towards closer integration of imaging, navigation, instruments and implants to provide further benefits to patients, doctors and payers alike, and to co-develop break-through robot-enabled surgical techniques.”
About KB Medical
KB Medical SA, is a Swiss company focusing on design, development and commercialization of the AQrate Robotic Assistance System for assisting surgeons during neuro and orthopedic surgery. The AQrate technology and intellectual property will empower surgeons with precise, cost-effective, robotic-assisted surgeries. Our mission is to improve patients’ outcome and quality of life as well as to reduce the received radiation by the operating room team during the surgery.
(Press release)