Author: Antonio Berlen

FDA Clearance for joimax® Vaporflex® and Legato® electrosurgical probes

Posted on by Antonio Berlen

Irvine, CA and Karlsruhe, Germany – November 9th, 2016 – joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vaporflex® and Legato® electrosurgical probes with radiowave technology for open and endoscopic spine surgery.

Those joimax® Electrosurgical Instruments are comprised of a series of instruments to facilitate the delivery of electrical energy from an RF generator to the patient tissue for use in cutting and/or coagulation of tissue. All Vaporflex® and Legato® probes use radio frequency which is generated by high oscillating electrical current received from a commercially available RF generator.

The new Vaporflex® system is optimized for versatile use due to different lengths, diameters and probe tips to allow endoscopic transforaminal and interlaminar procedures. It is both compatible and cleared also for the use with all Endovapor®/SurgiMax® and SurgiMax® Plus electrosurgical units and enables an easy swap of the Triggerflex® to the new Vaporflex® system. The bipolar Vaporflex® probes can easily be adopted to the complete range of joimax® systems. joimax® offers all its probes in a kit containing a sterilization tray, the hand piece as well as a shaft and a connection cable.

The monopolar and bipolar Legato® probes which support the rhizotomy procedures with the existing Multiuse and both newly launched products MultiZYTE® RT for Facet Joint Denervation and MultiZYTE® SI for SI Joint Therapy.

“Both the Vaporflex® and Legato® probes are ready for several generations of radiofrequency generators” says Wolfgang Ries, CEO and founder of joimax®. “Spinal surgeons are now enabled to perform the range of joimax® procedures with even more flexibility and ergonomics in the USA as well. This way we further enhance surgical interventions in endoscopic minimally-invasive spinal surgery” he continues.

Virtual Global Symposium on Minimally Invasive Spinal Surgery Highlights Livestream Training Benefits

Posted on by Antonio Berlen

Karlsruhe, Germany — The Global Symposium of the ESPINEA® Academy in Karlsruhe, sponsored by joimax®, showcased how modern, advanced training for surgeons works. Earlier this month, over four days, more than 300 participants from around the world learned about the latest endoscopic surgical methods for spinal diseases. Via live demonstrations, twelve world-renowned spinal surgeons presented case studies, gave tips and tricks, and allowed people to look over their shoulders at endoscopic videos while operating on cadavers. The livestream made it possible for participating surgeons to understand exactly how endoscopic operations are carried out.

“You can only get closer if you do it yourself,” said one participant.

joimax global symposium 2021

Endoscopic spinal surgery is developing into the gold standard for back problems that need surgery,” said Wolfgang Ries, the academy’s founder and chairman. “A large number of studies show it is superior to conventional methods of open spine surgery. Unfortunately, this technique is still not taught in most training centers around the world”.

ESPINEA® fills this gap with an extensive training program. Webinar formats are unavoidable in the Coronavirus period. With today’s livestream technologies, ESPINEA® was able to provide real-time, interactive surgical training, zooming in on how its surgical instruments can be used successfully.

“The participants’ enthusiasm is confirmation that we need to further develop online trainings,” said Ries. “While virtual events cannot replace face-to-face instruction — after all, it’s learning by doing — they provide an excellent alternative”.

ESPINEA® Academy was founded by joimax® in February 2019. A month later, joimax® CEO and Founder Wolfgang Ries held its first faculty and user meeting at the Paracelsus Medical University in Salzburg. Since then, ESPINEA® has been accredited by the oldest surgical college in the world, the Royal College of Surgeons Edinburgh. Participants at events such as the Global Symposium can earn medical training credits for Continuing Professional Development (CPD points). Points can be applied to medical license renewals.

Underscoring the importance of virtual learning, three ESPINEA® board members chaired the symposium: Menno Iprenburg from Iprenburg Spine Clinic in Veenhuizen, Netherlands; Sang-Ho Lee, president of Wooridul Spine Hospital, Korea; and J. N. Alistair Gibson, Royal College of Surgeons in Edinburgh. The participants concluded, “It was worth taking part just to hear these luminaries in person. But the best part was the opportunity to see the operation as if you were performing it yourself.”

Second international workshop incorporating live operations using the endoscopic spinal surgery method TESSYS® at the ATOS Private Clinic in Munich

Posted on by Antonio Berlen

Karlsruhe, 22nd June 2009: On 15th and 16th June the second international joimax® workshop on the endoscopic removal of disc hernias using the TESSYS® method took place in the ATOS Private Clinic in Munich. The highlight of this workshop was the live transmission of three operations, which the 15 workshop participants were able to follow from the comfort of the conference room in the neighbouring NH Hotel. Dr. med. Michael Schubert performed the operations on patients from Germany and Denmark, describing the individual steps and answering questions from the doctors in the auditorium during the operation. Two workshop participants were able to go into the operating theatre for each operation to observe the live procedure.
The live operations followed a day of intensive training on cadavers, allowing the doctors from Germany, Spain, Italy, USA, Jordan and Israel to get the most benefit from the live operations. Lectures by experts in the field of minimally invasive endoscopic spinal surgery completed the workshop.

joimax® presents the EndoLIF® system

Posted on by Antonio Berlen

Karlsruhe – As its latest development, joimax® presents the EndoLIF® system for endoscopic stabilization of the lumbar spine. The EndoLIF® system includes an O-cage
(oblique cage) in addition to fully endoscopic access technology to the intervertebral disc space with the proven TESSYS® or iLESSYS® technique. In addition, there is Percusys®, a screw and rod system for posterior percutaneous stabilization.

The advantages of this procedure are clear:

• Smooth, atraumatic access due to dilation of tissue
• Dura and nerves are protected by the working tubes
• Dorsal bone structures are unaffected
• O-cage made from titanium with honeycomb structure as optimal subsurface for cell growth
• Percutaneous stabilization with a screw and rod system, so minimally invasive too Both new systems are CE approved, not yet FDA cleared.

joimax® continues strong growth trend in 2017 with launch of its MultiZYTE® Facet and SI Joint treatment Set in the US and also obtains full approval of its Endovapor® 2 system in China

Posted on by Antonio Berlen

Karlsruhe, Germany – February 8, 2018 – the joimax® group announces very strong sales figures for 2017. The German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery shows a jump of almost 80% vs. 2016 in the U.S. Consolidated sales show a growth of nearly 30%, which reflects its CAGR of 35% since 2008.

“joimax® is in line with its top-line plans as well as with its EBIT growth projections”, states Rainer Schmitz, the long-standing CFO of the joimax® GmbH. “The company is now active in 50 countries and enjoys a strong reputation in Europe, Asia and the U.S.”

Based on the inclusion of the newly created AMA CPT code 62380 for endoscopic decompression of the lumbar spine as of January 1st, 2017, and the worldwide increasing adoption rate of the joimax® procedures in general, the company is gaining a strong foothold throughout the U.S.. The acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the patients and the surgeons are steadily growing worldwide.

The understanding and therapy of SI Joint is a rapidly growing new field worldwide. joimax® faces this growing area of unmet needs with its MultiZYTE® Facet and SI Joint Treatment Set in this market segment. The upcoming 3rd International Conference on Sacroiliac Joint Surgery (ICSJS), taking place in Tampa, FL from Feb. 21 to 24, 2018 gives attendees the opportunity to further enhance the level of understanding of the sacroiliac joint and to participate in a cadaver workshop at CAMLS learning center.

Further success in Asia is a result of the recent approval of the joimax® Endovapor® 2 Multi Radio Frequency System also in China, where joimax® has already been successfully in the market for 10 years.

“With this latest approval we now can market all our systems in this important country, which is a great step towards more targeted patient care” states Wolfgang Ries, Founder and CEO of joimax®.

The Endovapor® 2 generates electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations. The device is an all-in-one generator with specially integrated programs for spinal surgery with interdisciplinary application. It is equipped with two monopolar and two bipolar sockets and an easy and intuitive touchpad technology.  With arc control for safe application and easy neutral electrode monitoring, it combines a variety of electro-surgical modes and effects.

joimax Endoscopic Tower

joimax® Updates ESPINEA® Training Facility

Posted on by Antonio Berlen

KARLSRUHE, Germany – (BUSINESS WIRE) – The newly renovated and expanded Endoscopic Spinal Academy (ESPINEA®) facilities, sponsored by joimax®, makes exceptionally, high-quality training accessible in an innovative and appealing environment. Every day, the Academy offers educational and hands-on workshops to surgery teams, customers and partners.

Ries took on the newly created role of Executive Vice President, Business Development and Operations at joimax®. In this position, based in Germany, he will be responsible for scaling global operations to ensure joimax® continues its exponential growth. Formerly the General Manager, for the past six of his 13-year tenure with joimax®, Ries built out the United States and Latin American markets.

“We are continuously developing and adapting our programs to meet customer demand”.

Courses and workshops at a pre-clinical and clinical level

For almost five years, ESPINEA®, which is accredited by the Royal College of Surgeons of Edinburgh, has stood for excellence in training in the field of endoscopic spinal surgery. After the recent inauguration of ESPINEA® China, joimax® has refurbished and enlarged the existing Karlsruhe training facilities into a modern, state-of-the art center to support their growing educational and training programs. The showroom demonstrates solutions from joimax®, the market leader in endoscopic spinal surgery technologies, enabling visitors to experience this mastery daily.

Organized in sections, by product line, practitioners can try out each clinical model, simulating an operative environment, and learn firsthand about the positive ergonomics and streamlined workflow of these offerings. All labs are equipped with integrated joimax® surgery systems, including the latest generation endoscopic tower, NAVENTO®. The surgery stations are digitally connected to imaging and to the joimax® Intracs® electromagnetic navigation system so that the endoscopic spinal surgery methods and applications can be reproduced during training. Moreover, the furnishings have been fully optimized so that the rooms can be easily adapted to new products and solutions.

“As a leading innovator in spinal surgery techniques, it’s important that ESPINEA® offers a pioneering center to further education and training,” said Wolfgang Ries, CEO and founder of joimax® and chairman and founder of ESPINEA®. “The dynamic, holistic and needs-oriented program sets new standards.”

The main focus is on endoscopic spinal care solutions for pain therapy, decompression, deherniation, and spinal stabilization. All hands-on sections have an open lab design, and bring the concept to life on how the products work together.

Setting standards in training of endoscopic spinal surgery

Professional knowledge and well-practiced skills are the building blocks for successful endoscopic spinal surgery.

“We are continuously developing and adapting our programs to meet customer demand,” said Susanne Schmidinger, senior director, global marketing and education. “We are convinced that our holistic and target-oriented education puts surgery teams in the position to optimally implement our available technologies and solutions for their patients.“

At the facility, an experienced, dedicated global team of certified faculty share their expertise and know-how. Every trainee is individually accompanied along the entire learning journey.

“It’s important that surgeons be able to directly and efficiently apply joimax® systems and methods in their daily work,” said Ries. “That’s why we developed the ESPINEA® 3-step education program of visitation, hands-on workshop, and simulated live surgery.”

The program is available at ESPINEA® USA, Asia, China, and Europe.

joimax® for the first time awards the Parviz Kambin prize in cooperation with SMISS in the frame of the first US TESSYS® User Meeting in Denver, Colorado.

Posted on by Antonio Berlen

[29.04.2011] – Karlsruhe/Denver, Colorado, April 2011. After a very successful advanced cadaver workshop on Saturday, April 9, 2011, joimax® held its first US TESSYS® User Meeting on Sunday, April 10th in Denver, Colorado, the site of the Scientific Annual Meeting for AANS, the American Association of Neurological Surgeons.

In cooperation with SMISS, Society for Minimally Invasive Spine Surgery, joimax®, for the first time, presented the Parviz Kambin award to Dr. Parviz Kambin. Dr. Kambin is one of the most important pioneers who paved the way for the minimally invasive endoscopic spine surgery industry. The award was founded to honor outstanding surgeons in the field of endoscopic spine surgery. Dr. Parviz Kambin identified the unique safe access point to the spinal canal now known as the ‘Kambin triangle.’ Additionally, two experienced spinal surgeons, Dr. Michael Schubert, Munich, Germany and Dr. Menno Iprenburg, Veenhuizen, the Netherlands, were honored with the Parviz Kambin Award, each having performed more than 1.000 procedures of this kind, trained hundreds of doctors using the TESSYS® technique and each publishing scientific presentations held at renowned international congresses.

Dr. Choll Kim, Executive Director of SMISS and Associate Clinical Professor of Orthopaedic Surgery at the University of California – San Diego, “We, at SMISS, consider endoscopy of the spine to be a progressive technique with huge potential for the future of minimally invasive spine surgery. Aside from their operative work, we recognize the accomplishments of the recipients, who are large contributors to the advancement of the TESSYS® procedure on a global level.”

Besides the highlight of the award presentation ceremony, the User Meeting offered a robust program of scientific presentations, reports and discussions with internationally renowned spine specialists in the field of orthopaedic and neuro surgery. Additionally, joimax® started its celebrating event program 2011: 5 years joimax® Inc. in the USA and 10 years joimax® GmbH in Germany.

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

Posted on by Antonio Berlen

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.

Posted on by Antonio Berlen

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

Posted on by Antonio Berlen

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.