FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant

Irvine, California – July 13, 2015 (BUSINESS WIRE) – The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage.

The EndoLIF On-Cage® consists of titanium alloy, produced with Electron Beam Melt (EBM) technology. The cage displays a porous surface with diamond cell structure, providing an optimal base for cell proliferation and bone growth. Two large openings, which may be filled with autogenous bone, support the creation of a straight column for fusion.

The EndoLIF® implant allows surgeons to utilize an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, enabling endoscopic-assisted fusion. Dr. Ralf Wagner, LIGAMENTA Spine Center, Frankfurt and Dr. Bernd Illerhaus, ONZ, Datteln/Recklinghausen, two German spine specialists, have already performed more than 200 out of 600 EndoLIF procedures in Europe. “The access is dura and nerve-gentle, preserves the dorsal bony structures and we can avoid scar tissue because of the stepwise tissue dilation,” said Dr. Illerhaus.

The EndoLIF® On-Cage is designed to be used with supplemental posterior fixation, such as the joimax Percusys® percutaneous pedicle screw-rod system. Cage implantation can be performed with a posterior or postero-lateral approach, either using an open or endoscopic-assisted method.

“With the EndoLIF® program, joimax offers a complete endoscopic-assisted solution for spinal stabilization and fusion. In the future, we will be able to treat patients with even more gentle techniques,” comments Wolfgang Ries, CEO and founder of joimax®. “Our next development will be an EndoLIF® Cage on the basis of our iLESSYS® Delta system for posterior lumbar inter-body fusion (PLIF).”

Parviz Kambin Award for three joimax® Faculty Members

During a special joimax® faculty meeting which was held at the institute of anatomy at the University of Mainz, Germany on June 20-21, joimax® honored three surgeons with the Parviz Kambin Award. Dr. Albert Telfeian, Rhode Island Hospital, Brown University, RI, US and Dr. Gabriele Jasper, Center for Pain Control, NJ, US received the award in recognition of their outstanding scientific and educational dedication to transforaminal surgery. The two surgeons tremendously contributed to this field with numerous high quality publications. Also they are treading new paths for spinal endoscopy. Just recently Dr. Telfeian did the first awake surgery to remove a thoracic spinal tumor. Dr. Menno Iprenburg, Iprenburg Herniakliniek, NL received the award for his lifetime achievement. Dr. Iprenburg is applying joimax techniques, especially TESSYS, since 2004. In his private clinic, he successfully treated more than 2000 patients suffering from disc herniations.

The award is named after Dr. Parviz Kambin who identified a workspace within the intervertebral foramen, through which the spinal canal can be accessed safely. Because this safe zone is somewhat triangular shaped, it was named the „Kambin triangle“.

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On the left: Award winner Dr. Menno Iprenburg (r.) with joimax® CEO Wolfgang Ries (l.) On the right: Award winners Dr. Albert Telfeian (r.) and Dr. Gabriele Jasper (l.) with Wolfgang Ries (m.)

joimax launches the iLESSYS® Delta system for treatment of spinal stenosis at DGNC 2015 annual meeting

Karlsruhe, Germany – June 8, 2015 (BUSINESS WIRE) – The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it will introduce the company’s new iLESSYS® Delta system to the market at the 66th Annual Meeting of the German Society of Neurosurgery (DGNC) taking place in Karlsruhe, Germany from June 7-10.

iLESSYS® Delta, an advanced development of the joimax iLESSYS® technology, is suitable for dorsal and dorso lateral treatment of central spinal canal stenosis. The iLESSYS® Delta system enables a large area to be decompressed by means of the interlaminar access, guided by endoscopic-assisted vision.

“Since the access to the spine is the same as with the already well-established iLESSYS® technique, usage is very straightforward.” said Dr. Guntram Krzok, orthopedic surgeon from Waltershausen, Germany after testing the new system at a joimax workshop early this year. “I was impressed by the new scope which delivers outstanding image quality. With the specialized instrument set, it is finally possible to achieve decompression of central spinal canal stenosis.”

The iLESSYS® Delta instrument set includes specially developed tools that enable extensive, yet gentle, tissue-sparing decompression. The 6 mm working channel of the new endoscope allows for the use of large shaver blades designed for bone resection and endo-kerrisons. An additional option is the plastic (PPSU) working tube for unimpaired X-ray examination.

“iLESSYS® Delta is a logical addition to our portfolio. Not only is the system suitable for endoscopic decompression, but it also allows the parallel implantation of cages. This way we can achieve dorsal decompression and stabilization in one step,” comments Wolfgang Ries, CEO and founder of joimax.

About joimax

Founded in Karlsruhe, Germany, in 2001, joimax® is one of the leading medical device companies in minimally invasive spinal surgery („joined minimal access“). The company’s U.S. subsidiary was established in Irvine, California, in 2005. The company is primarily focused on the development, production and marketing of technologies and methods for minimally invasive endoscopic spinal surgery. joimax is active in 40 countries around the globe and its methods have been successfully employed in approximately 130,000 surgeries. With a special focus on education, the company provides surgeons with specialized technique training through the three-step joimax CM3 education program. This program includes visitations, cadaver workshops and live-surgery support.