November 02, 2016
STOCKHOLM–(BUSINESS WIRE)–Top German spine clinic reports successful application and ease of use for lateral MIS fixation in complicated surgical corpectomy.
OrtoWay AB, the Stockholm-based medical technology company, says its OrtoWell® device was used for the first time in a lateral, minimally invasive surgical (MIS) fixation procedure as part of a corpectomy at the renowned Dreifaltigkeits-Krankenhaus Clinic in Cologne, Germany. The CE-Marked device, now approved for most anterior-approach surgeries, was used to position an implant in a 39-year-old male patient suffering from inflammation in the L1 and L2 vertebra.
Quicker fixation with high accuracy
Developed in Sweden by a group of biomaterial and spinal experts, the OrtoWell device offers time-saving possibilities for surgeons, giving them more freedom and supporting fixation of the vertebra. The instrument fixates the vertebra in a unique way that allows for less complicated insertion of implants and can be used with any prosthesis. It is currently approved in Europe (CE Mark) and the US (Class 1 medical device), and was recently extended to include spinal tumor surgery.
Very good holding strength
“When replacing vertebra in the lumbar spine, it’s important to have tools that are easy to use and support accurate positioning and holding strength,” says Dr. Biren Desai, the leading spine surgeon who carried out the operation at the Dreifaltigkeits-Krankenhaus clinic. “Not only did the OrtoWell device help simplify the operation but I was impressed by the very strong, smooth hydraulic operation.” His clinic specializes in spine surgery, orthopedics and sports traumatology, treating 19,000 patients a year and carrying out more than 4,000 operations.
Novel hydraulically powered system
The OrtoWell Distractor is a novel hydraulically powered system that separates and holds apart vertebral bodies in the spinal column during anterior surgery. It consists of some non-disposable parts (distractor unit, spanner unit, retractors and frame, tools) as well as disposable components (tube unit, gauge, hooks, bone screws). The use of gentle, yet powerful incremental hydraulic force to prevent the vertebrae from collapsing or moving during operations is beneficial to surgeons since it facilitates correct positioning of spinal prosthetics such as disc implants and ALIF cages.
Many areas of potential usage
“We’re delighted to see this proof of successful usage of our device and believe it has the potential to become a successful tool for many aspects of spinal surgery,” says Stan Mikulowski, CEO of OrtoWay AB. Other possible areas of application include degenerated discs, tumor removal and various situations where vertebral distraction is required. “We are strongly committed to improving patient outcomes with the help of superior spinal technology,” he concludes.
About OrtoWay AB
OrtoWay AB was founded in 2006 by a group of experts in biomaterials, spinal surgery and medical technology who were looking for ways to improve anterior surgery and implantation of spinal prosthesis in the lumbar region. The developer behind the OrtoWell Distractor system, OrtoWay AB is today a Swedish privately held medical technology company that is seeking partners for commercialization. The OrtoWell instrument has CE marking for medical devices in Europe and is approved for usage as a Class 1 medical device in the USA. The product will be made available through OrtoWay LLC, an independent company based near Philadelphia, Pennsylvania, USA.
OrtoWay has received patents for this invention in Europe, the USA and in Australia.
OrtoWell is a registered trademark in the USA, EU and Australia.
Currently OrtoWay is looking for partners to commercialize this invention.
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