Posted byOrthoEx Posted in
Posted on Apr 11, 2018

STOCKHOLMApril 11, 2018 /PRNewswire/ —

OrtoWay AB, the Stockholm-based medical technology company, will present a scientific abstract at ISASS18 in Toronto, Ontario, Canada on April 11, 2018, documenting the clinical use of its OrtoWell® device for the first time in a lateral, minimally invasive surgical (MIS) fixation procedure. The CE-marked device, which is now approved for most anterior-approach surgeries, was used at the renowned Dreifaltigkeits-Krankenhaus Clinic in Cologne, Germany to position a spinal implant in a 39-year-old male patient suffering from inflammation in the L1 and L2 vertebra.

Three-step operation strategy
Submitted by Dr. Biren Desai, Head of Department Spine Surgery at the Cologne-based clinic, the ISASS18 abstract is entitled: Introduction to using a novel hydraulically powered system – OrtoWell® Distractor – to separate vertebral bodies during anterior surgery: Case report of a spine inflammation with need for 2-level corpectomy, vertebral body replacement and fusion. Commenting on the scientific paper, he says: “We adopted a three-step surgical strategy involving an anterior lateral procedure to replace the L1 and L2 vertebra and then connect a Th-L plate from Th12 and L3 vertebra followed by posterior MIS fixation.”

Accurate positioning and fixation
According to Dr. Desai, the decision to use the OrtoWell® distractor tool was based on a desire to gain more freedom of working space, ensure smooth separation of the vertebra and support accurate fixation. “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,” he says. “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.

Resisting spinal compression forces
OrtoWell® was developed in Sweden by biomaterial and spinal experts who were looking for better tools to overcome the challenges of strong spinal compression forces, avoid the risk of damage to vertebra using hammers and other tools and improve accuracy. The system consists of several non-disposable components (distractor unit, spanner unit, retractor and frame, tools) as well as disposable components (tube unit, gauge, hooks, bone screws).

Strong and smooth hydraulics
“The use of gentle, yet powerful incremental hydraulic force to prevent the vertebrae from collapsing or moving during operation is beneficial to surgeons since it facilitates accurate positioning of spinal prosthetics such as disc implants and ALIF cages,” says Stan Mikulowski, CEO of OrtoWay AB, who adds: “In addition to corpectomies, the reliable distraction of vertebra can support a wide range of spinal procedures, including tumor removal, disc removal and artificial disc replacement, ALIF and scoliosis.”

CE Marked for Europe; FDA approved
The OrtoWell® device, which is CE Marked for Europe and FDA approved (Class 1 medical device). The company is currently performing a clinical trial program together with several clinics in Germany.

Many potential application areas
“We see many potential areas where the OrtoWell device could be a big support to spinal surgeons,” says Mr. Mikulowski. “The entire team at OrtoWay is strongly committed to improving patient outcomes with the help of superior spinal technology.”

About OrtoWay AB
OrtoWay AB was founded in 2007 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.

The International Society for the Advancement of Spine Surgery (ISASS) is a nonprofit scientific and educational society organized to discuss and assess existing strategies and innovate ideas in the clinical and basic sciences related to spine surgery to enhance patient care. Headquartered in New York, the organization partners with physicians, patients and the medical industry to advocate for high-quality, widely accessible and cost-effective spine care for patients around the world.

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.


The receive a copy of the scientific paper or discuss possible collaborations, please contact:
Stan Mikulowski,
CEO / Partner/ Owner, OrtoWay LLC, PA, USA

Cell phone: +46-708-769-991, From the US; 011-708-769-991

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