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® 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.

[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.

Winner_Kambin_Award_2011

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.

joimax® Wins 2019 Spine Technology Award for its Integrated Navigation Tracking & Control System, Intracs®em and Exhibits at NASS

Irvine, CA – joimax®, a leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery, is pleased to announce they’ve won a 2019 Orthopedics this Week Spine Technology Award for their new Integrated Navigation Tracking & Control System, Intracs®em. joimax® will be recognized with the award during the annual North American Spine Society Meeting (NASS), taking place September 25-28 in Chicago.

joimax® is heavily involved in this year’s NASS program. On Wednesday, September 25, they will host three stations at the new, hands-on, full-day course, NASS/Neurospine Endoscopic Spinal Surgery Symposium and Cadaver Workshop, co-sponsored by KOMISS. Moreover, joimax® will present the latest technologies at their booth, No. 3416, including Intracs®em, the first electromagnetic system for endoscopic spine applications. Earlier this year, Intracs®em received its CE mark and is already very successful within Europe and Asia. It is pending FDA clearance; expected before year end.

joimax® is also presenting ESPINEA®, Endoscopic Spine Academy, with its complete joimax® endoscopic education curriculum, which will play a crucial role in educating the next generation of endoscopic spine surgeons. Additional highlights in the booth will be the 4K Endoscopic tower and its optimal solution for endoscopic spinal surgery, as well as the latest 3D-printed EndoLIF® Cage family, consisting of the EndoLIF® O/On-Cage, DoubleWedge-Cage and Delta- Cage.

Wolfgang Ries, joimax® CEO and Founder states, “We are excited about the most recent developments within the US market. We are experiencing a great movement towards joimax® procedures, such as TESSYS® and iLESSYS®, from academics as well as private institutions. With our recently established ESPINEA® and the support from societies such as NASS, we believe we are at the tipping point where joimax® endoscopic spine surgery will become the gold standard of treatment in the US market.”

joimax® presents the EndoLIF® system

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.

Cominco

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

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.

Vaporflex Illustrations joimax®

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.

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.

joimax® Enters the Vietnamese Market, Partners with Trang Thi Medical Company Limited

Karlsruhe (GER) – joimax® and Trang Thi are pleased to announce their partnership in bringing the joimax® full-endoscopic and minimally invasive spinal surgery technology to the Southern Provinces of Vietnam including Da Nang market.  joimax® a German-based company is a recognised market leader in these technologies and training methods with a history of innovation in endoscopic spine surgery since 2001.

Endoscopic Spine Surgery has been growing steadily in popularity since the late 1990’s and there has been exponential growth in the technique in the past 10 years. The distributor Trang Thi and joimax® are pursuing a long term corporation to provide a broader surgical choice for patients considering spinal surgery. “joimax® is looking forward to working with a partner as strong as Trang Thi, says joimax® Founder and CEO Wolfgang Ries and adds, “a company that has the necessary personnel, expertise, as well as the corresponding specialization and penetration of the market”.

“We’re very pleased to collaborate with joimax®,” comments Trang Thi Medical Co., Ltd Director Dieu Linh Nguyen. “Endoscopic spine surgery is a technique that enables patients to have access to truly minimally invasive surgical procedures of the spine.” Thus, joimax® strengthens its sales activities in Southern Provinces of Vietnam including Da Nang and enters into another important partnership across APAC.

About Trang Thi Medical Co. Ltd
Trang Thi Medical Co., Ltd (TRANG THI) is one among key players in Vietnam market, providing complete solutions for neuro and spine surgery. During the nine years of operation, TRANG THI has cooperated with many well-known manufacturers, transfering advanced and innovative technology to hospitals and healthcare centers. With the mission of community health, Trang Thi always strive to make a real difference to people’s lives.

joimax Partnership with Trangthimedical, 2021

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“.

Collage_Award_Winners.tif

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® – the 1st US TESSYS® User Meeting in Denver, Colorado, USA heralds 10-year anniversary celebrations

At the same time joimax® Inc., the US subsidiary celebrates its fifth anniversary, exhibits at the AANS and for the first time awards the Parviz Kambin prize in the frame of the second international TESSYS®-User Meeting in Denver, USA.

 

 

Karlsruhe, April 6, 2011. joimax® GmbH holds the 2nd International TESSYS® User Meeting in Denver, USA on April 9th and 10th. At this event, the Karlsruhe based medical device
company starts the celebration activities on the occasion of its 10th anniversary in Germany and its 5th year of existence worldwide – a special occasion in combination with the AANS
Annual Scientific Meeting (American Association of Neurological Surgeons) from April 9th – 13th, 2011.

„We are particularly proud to announce the first ever Parviz Kambin Award“, says Wolfgang Ries, founder and CEO of joimax® GmbH. „With this award we value the neurosurgeon Dr.
Parviz Kambin’s research and work as an important pioneer in the field of minimally invasive spinal surgery. The TESSYS® procedure uses what is known as the Kambin-triangle as its
point of access to the spinal canal.“

The User Meeting offers an optimal platform for TESSYS® users, surgeons, scientists and sales partners to share their experience with the method, further technologies and case
studies as well as learn and test new products and techniques such as the iLESSYS® System, now being launched.

On April 9th, joimax® starts its celebrations with an advanced cadaver workshop which focuses on endoscopic spinal stenosis treatment with TESSYS® Stenosis, the Shrill® Shaver
Drill System and now iLESSYS® method as well. The iLESSYS® method enables the surgeon to fully endoscopically remove transforaminally difficult-to-reach herniated discs and also
stenoses via an interlaminar approach.

The joimax® founder Wolfgang Ries will also give an overview of the history of the company reflecting the past five and ten years of the company and will also provide an outlook on
future products and systems.

The scientific program of the event will include a variety of technical lectures, presentations and discussions on the TESSYS® method including reports on first experiences with the
Shrill® System and iLESSYS®.

joimax® and Red One Medical Partner to Support Expert Endoscopic Minimally Invasive Spine Surgery for Veterans and Active Military

SAVANNAH, GA – joimax®, a leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery, and Red One Medical, a Service-Disabled Veteran-Owned Small Business, announced their partnership today. The partnership enables both companies to continue their missions to improve patient care and surgical outcomes with leading edge medical technology and devices.

Red One Medical Founder and CEO Charles Pollak shared, “I am excited to join forces with joimax® to offer their innovative technologies, systems and methods for endoscopic minimally invasive spinal surgery to VA and DoD facilities across the nation, further supporting the government’s goal to improve outcomes and improve efficiency in these facilities.”

Matt Cronin, senior VP of sales and marketing for joimax®, is a U.S. Navy veteran and hailed this partnership: “This is a pivotal moment for joimax® and our long history. We are honored to be a part of improving health care for our many veterans and our brave U.S. military personnel, as well as for their dependents. Our working together with Red One Medical will make endoscopic spine surgery more accessible to this patient population, where a quicker return to both duty and a more active life, is so important.”

About Red One Medical:

Red One Medical is a CVE-certified Service-Disabled Veteran-Owned Small Business (SDVOSB) located in Savannah, GA. Wholly owned and operated by a combat veteran, Red One Medical is a leading medical device distributor and wholesaler serving the Department of Veterans Affairs (VA) medical centers and Department of Defense (DoD) hospitals. Red One Medical donates a portion of profits to leading charities as part of its mission to support veterans, military families and their communities. To learn more, visit http://www.redonemedical.com/

RED-ONE-joimax-collaboration, Military, veterans, endoscopic spine experts, endoscopic devices, endoscopic systems, treatment