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).”

joimax® starts the official sale of its EndoLIF® Delta and DoubleWedge cages. All three members of EndoLIF® family CE approved.

Karlsruhe, GER– July 15, 2019 –joimax®, the Germany-based market leader of technologies and training methods for full-endoscopic minimally-invasive spinal surgery, announces the official sales launch of its complete EndoLIF® family. EndoLIF® is an instrument set for endoscopic-assisted minimally invasive lumbar interbody fusion. As already announced and showcased at earlier events, the EndoLIF® product line consists of three members now: the well-known EndoLIF® O/On-Cage, the EndoLIF® Delta Cage, and the latest EndoLIF® Double Wedge Cage. The complete EndoLIF® product family is now CE-approved and fully available. Moreover, the EndoLIF® O/On-Cage is FDA-approved.

All EndoLIF® Implants are manufactured using a 3D printing process, which ensures an open diamond cell structure. The cages are safely implanted via the guide wire and are fillable with bone or bone substitute material. With their rough and porous surface, the implants guarantee optimal bone ingrowth, stability and finally fusion.

The EndoLIF® Cage family provides the right implant for every patient and is the perfect solution for endoscopic spinal fusion. With the gentle and atraumatic access via gradual tissue dilatation, muscles remain intact leaving important biomechanical structures in place after surgery.

Like with any endoscopic procedure compared to open surgery, all advantages for fusion are now given with the EndoLIF® program also. With one EndoLIF® Instrument Set all three cages of the EndoLIF® family can be implemented.

Endoscopic spine surgery, spinal stabilization, endolif, endoscopic device, full endoscopic, systems for stabilization

Dr. Florian Zentz, (Munich, GER) emphasizes “the extraordinarily high primary stability of the EndoLIF® DoubleWedge-Cage”. He continues enthusiastically: “After insertion the cage sits very firmly in the intervertebral disc space and adjusts the angulation up to 18 degrees, almost directly enabling an optimal lordosis correction.”

Dr. Ralf Wagner, (Frankfurt, GER) is also convinced of the obvious advantages: “The Delta Cage is ideal for the posterior lumbar interbody fusion (PLIF) offering a gentle posterior alternative, especially at level L5-S1 with its large interlaminar window.

joimax®, EndoSphere Spine, LLC and the University of Toledo, Ohio, have signed a license agreement on endoscopic cage technologies

Karlsruhe, 23 October 2012. joimax® as the recognized pioneer in endoscopic spine surgery has launched the transforaminal access to the spinal canal under the brand name TESSYS® in 2004. Since then the company has consistently extended its product range and covers the complete array of therapies for spinal disorders with its systems today.

TESSYS® and iLESSYS® are applied especially for the treatment of disc herniations and stenosis utilizing the transforaminal or interlaminar access to the spinal canal, aiming for a long lasting decompression. In the area of pain therapy the company offers the products of the Multiuse series for endoscopic rhizotomy and PeNuts® for percutaneous nucleus therapy. The product range is completed by systems and products in the field of VBA management.

Consequently the next step in the evolution of the joimax® product portfolio is the stabilization and restoration of the spinal column. With the joimax® EndoLIF® programme – the term stands for Endoscopic Lumbar Interbody Fusion – various cage technologies are brought into the intervertebral foramen step by step under endoscopic view. The cage is then being filled with autologous bone or a substitute material under endoscopic control also, the intervertebral disc space and hence the whole spine segment is raised and stabilized. This will be the world’s first interbody fusion device which can be inserted under direct vision.

EndoSphere Spine’s founding members Professors Vijay Goel, PhD and Anand Agarwal, MD at the University of Toledo are among the world leading researchers in the development of biomedical device for the spine. With the assistance of a team at the University of Toledo, they have developed the cage technology, in particular a novel ring cage that is being licensed to joimax® on an exclusive worldwide basis. Prof. Goel is enthusiastic with the idea to position the cage technology using the joimax® minimally invasive access technique: “The combination of our know how with the joimax® expertise leads us to a unique concept that will dramatically push endoscopic spinal surgery forward.” His colleague Prof. Agarwal considers it even a “quantum leap forward”. “In the team at the University of Toledo and the co-founders of EndoSphere Spine, LLC (Profs Goel and Agarwal) we have found a brilliant partner to provide the spine surgeons with state-of-the-art implants for most atraumatic interventions”, adds Wolfgang Ries, CEO and Founder of joimax®.

Both parties share the vision and mission of creating pioneering technologies in order to quickly bring back patients to their usual quality of life in the long run.

About The University of Toledo
Established in 1872, The University of Toledo is home to nearly 22,500 students across 13 colleges and six Ohio campuses. The University offers more than 230 doctoral, professional, graduate and undergraduate programs. UT has earned national and international acclaim for its expertise in medical bioengineering, solar and advanced renewable energy, environmental sciences, astronomical research, translational research and biomarkers.

COA 2016 in Beijing, China: joimax® shows major presence and inaugurates new NASS-joimax® MISS training centre

joimax® presence at COA Congress 2016

Irvine, CA and Karlsruhe, Germany – November 28th, 2016 – joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, again exhibited at Chinese Orthopedic Association (COA), which has taken place from Nov 17th to 20th, 2016 at China National Convention Center in Beijing, China. During the exhibition, the new NASS – joimax® MISS Training Centre has been inaugurated.

The 18th Chinese Orthopedic Association Annual Meeting and the 11th International Congress of Chinese Orthopedic Association (COA) this year has again taken place in Beijing and was visited by around 35,000 surgeons gathering for the latest research results and up to date information on technology and clinical progression in orthopedics including Spine Surgery. joimax® had a major presence with a large booth showing its endoscopic minimally invasive product range. Furthermore on the two major meeting days 30 lectures of well-known experts were given at its booth.

Moreover, joimax® also presented its latest product, the newly launched Intracs® Interaoperative Navigation Tracking & Control System for the first time in China.

During the COA the new NASS-joimax® MISS Training Centre in China has been inaugurated on Friday Nov. 18th, 2016. The ceremony has taken place at the joimax® booth together with leaders from the Peking University Third Hospital and members of the NASS Board of Directors. The Chinese market is a very important one for joimax®: Chinese surgeons are highly interested in adopting and deepening their knowledge in endoscopic minimally invasive techniques. joimax® is playing a major role in advanced training and is a driving power in the field of continuing education.

“With the launch of TESSYS® IseeUTM, which has been newly designed especially for the Chinese market, joimax® offers an even more simplified access under facilitated orientation”, says Wolfgang Ries, CEO and founder of joimax®. “The existing TESSYS® trays can furthermore be upgraded with the TESSYS® ISeeUTM supplements” he continues.

From left to right: Edward Dohring, MD, NASS Board of Directors; Prof. Yue Zhou, Xinqiao Hospital, Chairman of Chinese Society for MISS and joimax® faculty; Jeffrey C. Wang, MD, NASS Board of Directors; Prof. Xiaoguang Liu, Vice President Peking University Third Hospital; Prof. Jie Qiao, President Peking University Third Hospital; Wolfgang Ries, CEO & founder joimax® GmbH; Brad Repsold, NASS Assoc. Executive Director; Michael Roberz, International Sales Director joimax® GmbH; Qinguang You, General Manager joimax® China.

joimax® Celebrates 20th Anniversary, Expands Education Program

Karlsruhe (GER) — Founded 2001 in Germany, joimax®, the leading manufacturer of medical devices for endoscopic minimally invasive spine surgery, celebrates its 20th anniversary this year. In tandem with this milestone, the company expanded their educational program, ESPINEA®, furthering their global reach.

Despite COVID-19, ESPINEA® (Endoscopic Spine Academy) training programs, which are held in cooperation with the Royal College of Surgeons Edinburgh (RCSEd) and joimax®, were conducted all over the world in 2020, and continue to roll out in 2021. Due to travel restrictions, the programs were adapted to webinars, and remote support and training, totaling 60 sessions last year. By pivoting to online learning, approximately 3000 surgeons were reached in 2020, and 700 surgeons so far in 2021. ESPINEA® was founded by joimax® CEO and Founder Wolfgang Ries in 2019, and was accredited by the RCSEd last year. 

“Our goal is to be globally present online, as well as to provide direct local support,” says Ries. “Regardless of lockdowns in many countries, under the ESPINEA® platform, more than 120 surgeons were trained in onsite workshops this quarter, with 70 in the USA and Mexico, 35 in Europe, 15 in Asia, and many more through the joimax® CME-program partnership in China.

ESPINEA® Board Member Alastair Gibson, FRCSEd states: “These efforts demonstrate that joimax® and ESPINEA® can achieve anything together. I’m proud to be part of this impressive blend of online, on-site, and remote events, enabling a strong ESPINEA® community.”

joimax global expansion during covid 19

To support the roll out, additional Coronavirus-compliant labs were integrated into the local, onsite education programs. In addition to the company’s existing labs in Karlsruhe and Irvine, California, more labs throughout the USA, including Houston, Minneapolis, New York City, Dallas, and Indianapolis, as well as the Surgical Skills Lab in Mexico City and ORSI Academy in Melle, Belgium, have been added.  Also, joimax® opened a branch office in Singapore; the Hong Kong office was opened in spring 2019.

“It is becoming increasingly important to have a personal, on-site presence in order to teach globally-valid learning content,” adds Ries. 

First TESSYS® OP performed in the Oberwallis Spitalzentrum in Switzerland

Dr. Florian Alfen
Dr. Florian Alfen

Oberwallis / Switzerland, 24.07.09. The first intervertebral disc operation using the joimax® TESSYS® method for the endoscopic removal of herniated discs was recently performed in the Oberwallis Spitalzentrum in Brig, Switzerland. Dr. med. Uwe Schwarz, Chief Physician of orthopaedic surgery, carried out the two and a half hour long procedure to remove a lumbar disc herniation together with spine specialist and joimax® Senior Faculty Member Dr. Florian Maria Alfen from Würzburg (pictured left). The patient was able to leave the hospital on the same day.

joimax® celebrates 10 years of TESSYS®

Karlsruhe – Since 2004 more than 100,000 patients in 30 countries (up to August 2014) have undergone surgery with the TESSYS® method and its later developments. The latest studies reveal a shorter recovery time, a quicker return to work and normal quality of life, and an associated reduction in the impact on welfare systems.

joimax® looks back on 10 years of successful application of the TESSYS® procedure for minimally invasive endoscopic removal of herniated discs – a particularly gentle surgical technique using the naturally occurring transforaminal opening to the spinal canal. TESSYS® was the first product that joimax® launched onto the market and it helped the company make its breakthrough. Since then, joimax® has greatly diversified its product portfolio for 360° surgery in virtually all areas of the spinal column, including endoscopic and percutaneous stabilization.

joimax® Presents Its New Generation 4K Camera Light Source and Documentation Command System, Camsource® LED and Vitegra® at AAOS in New Orleans, LA

Karlsruhe, Germany – March 7th, 2018 – joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery presents its newest combined 4K resolution camera and LED light source system, Camsource® LED and its fully integrated documentation and command system, Vitegra® Docu and Command. Both systems are introduced for the first time at the Annual Meeting of the American Association of Orthopedic Surgeons (AAOS), currently taking place in New Orleans, LA where joimax® is represented at booth no. 4020.

The Vitegra® Docu and Command system opens a new era of documentation, control and hospital integration. The device comes with numerous flexible control options including a wireless tablet PC, live video streaming and a live voice commenting option, in-surgery image and video review function, voice control capabilities and easy data export solutions. The Vitegra® offers with its command mode to control all other devices that are part of the joimax® endoscopic tower. An optimized monitoring of the endoscopic devices during the surgical procedures by live review and control of all important device parameters is also provided. An initial, limited market launch is planned for Q2/2018 within European and U.S. markets.

“Our new 4K LED Visualization Systems are the next important components of our steadily growing endoscopic product portfolio. These developments demonstrate our continued leading position in the fast-growing endoscopic spine surgery market worldwide,” states Wolfgang Ries, Founder and CEO of joimax®.

jomax Vitegra Docu and Command, Camsource LED

joimax® demonstrating its innovative minimally invasive endoscopic spine surgery solutions at Global Spine Congress 2023

joimax® demonstrating its innovative minimally invasive endoscopic spine surgery solutions at Global Spine Congress 2023

Prague, Czech Republic | June 2023 – During this years Global Spine Congress (GSC) joimax® CEO & Founder, Wolfgang Ries, talked to the GSC Chairman, Jeffery Wang, MD, PhD about the latest innovations by joimax®.

Click the link below to see the full interview! 

https://youtu.be/vTiTHGuHFCs

User Meeting Heidelberg

joimax® sets the second highlight in its anniversary year: The TESSYS®/iLESSYS® User Meeting in Heidelberg

Karlsruhe/Heidelberg, 20 June 2011. After the success of the User Meeting in scope of the AANS Annual Scientific Meeting in Denver, Colorado in April, joimax® invited customers and users of their systems to attend the User Meeting in Heidelberg.

The meeting provided an ideal discussion forum for the TESSYS® users, orthopedic and neurosurgeons with scientific lectures, experience reports and an extensive practical session at the Institute for Anatomy and Cell Biology of the Heidelberg University. joimax® placed the focus on their new products with the shaver/drill system SHRILL® and the iLESSYS® instrument kits, that represent the consistent further development of the well-known and proven joimax® platform for endoscopic spine surgery. Dr. med. Carl Hans Fu?rstenberg, Senior Consultant and Deputy Head of Spinal Cord Injury and Head of Operative Spinal Cord Injury Department of Orthopaedics, Trauma Surgery and Spinal Cord Injury at the University Hospital Heidelberg, was impressed with the, now comprehensive, access technique: „The circle has been literally closed now. With TESSYS® and iLESSYS® we have the 360 degrees access to the spinal canal.“ „With the complement of iLESSYS® for interlaminar access, the complete range of endoscopic access techniques to the spinal canal is now available, providing us a lot more options to help patients efficiently and fast “, stated University Lecturer Dr. Sandro Eustacchio from the Neurosurgery Department of the University Hospital in Graz, Austria, who has been practicing the interlaminar access method for quite a while and demonstrated it to the audience.

Another core theme was the application of the shaver/drill system SHRILL®, impressively presented by Dr. med. Guntram Krzok, Friedrichroda, who cannot imagine specifically stenosis therapy without this „fantastic instrument“ any more, as he stated. According to his experience, this instrument perfectly completes the indication array of endoscopic spinal surgery.

All participants praised the format of the meeting with being the right mix of theory and practice as well as the ideal forum for an extensive exchange of experiences between the experts. During the relevant congresses and exhibitions of the second half of 2011, joimax® will present and launch further product novelties starting at EuroSpine in Milan, Italy, and SMISS in Las Vegas in October, NASS in Chicago in November and later at the 6th German Spine Congress to be held in Hamburg in December 2011.