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® goes BRIC and beyond

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Right on time with the soon expected registrations of the joimax® products in Brazil – one of the most emerging BRIC economies – the German-based company showed a very successful presence at the third World Congress of Minimally Invasive Spine Surgery and Techniques (WCMISST) in Salvador de Bahia. The congress was supported by the main International MISS Societies. Almost 2.000 interested participants attended the congress which focused especially on promoting and enhancing the interventional minimally invasive treatment of spine diseases. joimax® is very proud of being part of this exciting development.

The eight largest emerging and developing economies by either nominal GDP or PPP are the BRIC nations (Brazil, Russia, India and China) as well as Mexico, Turkey, Indonesia, and South Korea. joimax® is represented in more than 60% of these countries – namely China, Russia, India, South Korea, and Turkey – and observes a fast growing number of registered products in these areas. In Brazil and Mexico submissions with the Health Authorities were started several months ago. The completion is expected in the near future. Then nearly 90% of the growth-leading economies will be covered.

joimax® provides the complete range of high-quality medical devices for minimally invasive endoscopic spine surgery “Made in Germany”. As a matter of course these devices are CE-marked and FDA-cleared and are sold throughout the European Union and the United States. The specific surgery methods they are used for, were developed by joimax® together with international experts and opinion leaders for the benefit of the patients:

Less pain, less trauma, less hospitalization, gain back quality of life and be back to work in shorter time!

The advantages are evident. Therefore joimax® has established a worldwide net of distribution partners allowing that as many patients as possible can get access to these progressive therapy methods.

Other important countries where joimax® is already present are: South Africa, Israel and Australia. One of the company’s goals within the next few years is to achieve the approval for its devices with the Japanese Ministry of Health.

Emerging and growth-leading economies are the key markets that are expected to lead global growth in the next 10 years. “joimax® is most pleased with its growing market penetration also in these countries, hence promoting these gentle, patient-friendly and economically beneficial surgery methods for the sake of the patients and of the health insurance systems at the same time”, states Wolfgang Ries, CEO and Founder of joimax®.

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“.

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® conducts an international Live Spinal Surgery Workshop in cooperation with the Medical University of Graz, Austria

Spine specialists take part at the joimax® endoscopy workshop with live spinal surgeries

Karlsruhe, 14 March 2011: On 17 and 18 March 2011, the Medical University as well as the Institute for Anatomy in Graz, Austria, were the sites of a two-day international joimax® Workshop focused on the endoscopic resection of herniated discs utilizing the TESSYS® method. The first day, Dr. Wolfgang Kreil and Univ. Doz. Dr. med. Sandro Eustacchio of the Medical University Graz will operate on two patients with herniated discs using the TESSYS® method. The participating orthopaedic surgeons and neurosurgeons from Germany, Austria, Greece, Bulgary, Italy and Macedonia will experience the surgery procedure firsthand. While operating on the patients, one of the operating surgeons will explain each step of the TESSYS® surgery and answer questions of the workshop attendees. Afterwards Dr. Wolfgang Kreil and Dr. Sandro Eustacchio will lead scientific presentations and panel discussions on how the transforaminal endoscopic technique works and what their experiences have been, while discussing several case examples.

On the second day, joimax® hosts an intensive cadaver training course at the Institute for Anatomy Graz. The practical training and hands-on learning experience gained at cadaver workshops such as this one is an important first step in the three-step joimax® CM3 Education Program. In this comprehensive program, experienced surgeons and application specialists train each workshop member to use the TESSYS® Method. The subsequent steps of the Education Program are visitations, followed by live surgeries accompanied by joimax® Medical Trainers and application specialists.

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

joimax® and spine experts from across the world at COMINCO in São Paulo

Karlsruhe – Spine experts from across the world met at the beginning of August at COMINCO (Brazilian Congress of Minimally Invasive Spine Surgery) in São Paulo. This was the fifth time that COMINCO has taken place and it provided an opportunity for large numbers of experts to share information and ideas in the fields of neurosurgery and orthopedics.

Minimally invasive treatment methods and their successes from the patient’s perspective were the focus of the congress. The very latest surgical possibilities and techniques were presented in symposia, workshops, and numerous lectures to a very high scientific standard. joimax® GmbH trainer, Dr. med. Ralf Wagner from Frankfurt, Germany, notably introduced TESSYS® in his presentation “Endoscopy of the lumbar spine in degenerative diseases.” This technique provides transforaminal access to the lumbar spine for treatment of herniated discs and stenosis – an osseous narrowing of the spinal canal.

Cominco

joimax® shows major presence at NASS 2016 with a User Meeting and Workshop at Harvard Medical School, a NASS CME Lab and an Expert Panel Forum at the exhibition booth

Irvine, CA and Karlsruhe, Germany – October 25, 2016 – joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, will again exhibit at the annual meeting of the North American Spine Society (NASS) 2016, taking place from October 26 – 29 in Boston, USA. Prior to the convention, on Monday, October 24, joimax® will hold a User Meeting followed by a workshop at the Harvard Medical School Conference Center. On Tuesday, October 25, the NASS CME-Lab with a joimax® station will take place. During the exhibition a group of internationally respected spine experts will also give presentations in a forum at the joimax® booth.

Key topics of the joimax® User Meeting will be centered around the endoscopic treatment of degenerative spinal diseases on the basis of the joimax® portfolio products with TESSYS®, CESSYS®, iLESSYS® Delta systems as well as EndoLIF® and Percusys®. A group of spine experts will share their expertise and extensive knowledge on the treatment of spinal diseases. The meeting will be completed with a cadaver lab with 3-4 stations at the Conference Center of the Harvard Medical School to train attendees on the whole range of endoscopic minimally-invasive spine surgery applications based on the joimax® techniques.

Tuesday’s NASS CME-Lab will be chaired by Professor Michael Y. Wang, M.D. FACS, University of Miami Miller School of Medicine, Miami, Florida, another pioneering spine surgeon and joimax® faculty member, who recently published a special edition in the Journal of Neurosurgery called Neurosurgical Focus, focused on Endoscopic Spine Surgery.

Additionally, joimax® will host a “Meet the Expert Forum” with presentations at its booth given by Dr. Ralf Wagner and Dr. Erik Traupe, both from Germany, and also Dr. Menno Iprenburg from the Netherlands. Topics discussed will include the benefits of spinal endoscopic transforminal and interlaminar decompression methods over traditional ones. joimaxs’® novel treatment options for advanced indications enjoy a fast growing adoption rate of its endoscopic technologies worldwide will also be discussed.

“In the context of the annual NASS meetings’ we aim to share the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. These joimax® activities will satisfy the requirements of spine specialists to take advantage of the latest innovations and technologies in endoscopic minimally-invasive spine surgery,” says Wolfgang Ries, CEO and founder of joimax®.

“With our existing product range as well as with our newly launched products – the MultiZYTE® SI endoscopic sacroiliac joint therapy set, MultiZYTE® RT for endoscopic minimally-invasive treatment of the facet joint and the new Intracs® Intraoperative Navigation Tracking & Control System, joimax® uniquely enhances its endoscopic minimally-invasive product portfolio to fully meet users’ needs,” he continues.

The Spine Movement – May 2012

Choll Kim, MD, PhD gives a breakdown of some of the most exciting presentations in MIS at ISASS12, and looks ahead to ISASS13 in Vancouver.

Minimally Invasive Surgery Was Huge at ISASS12

ISASS12 in Barcelona was a remarkable venue for numerous presentations related to minimally invasive spine surgery. Great interest both in the US and abroad continues to grow in this area of spine surgery: MIS made up the content for one-third of all the general sessions, with a sprinkling of individual presentations in other general sessions.

The range and complexity of the MIS topics proved broad. One of the most striking findings emerging in the literature is the marked decrease in infections when minimally invasive surgery is performed. Pfandistiener et al. from the Clinic for Spine Surgery with Scoliosis Center in Germany reported on infection rates between open and MIS posterior instrumentation. In 284 open surgeries, deep infections were seen in 2.46%. In contrast, 199 patients underwent percutaneous posterior instrumentation procedures without a single infection.

The use of minimally invasive strategies to treat ever more complex conditions were highlighted. Phillips and co-workers presented the prospective, multi-center results of 107 adult degenerative scoliosis with 24 month follow-up. Excellent clinical results and a low complications were encountered in this this challenging group of patients with advanced age and co-morbidities. Anand showed similar results in 33 patients from a single site.

The fusion rates of minimally invasive interbody fusion remains high. As shown in a meta-analysis by Gwinn et al. from Walter Reed Medical Center, the MIS TLIF technique enjoys a greater than 95% fusion rate.

Topics in endoscopic surgery continue to generate interest, as well–Nagahama et al. (Hokkaido University) and Schubert (Munich, Germany) showed continued success of this promising procedure in the hands of experienced endoscopic spinal surgeons.

Lingering questions regarding MIS were also addressed: Lee et al. (University of California, San Diego) quantitatively examined hip flexion strength after the popular transpsoas lateral lumbar interbody fusion (XLIF/DLIF/LLIF). As experienced by many surgeons, hip flexion strength decreased in most patients immediately postoperation, but returned to baseline within 2 weeks of surgery.

Cost effectiveness of open versus MIS TLIF was assessed by Phillips et al. on worker’s compensation patients; the cost of overall inpatient care was slightly less for MIS than for open.

Pimenta et al. advised appropriate caution when he described low fusion success rates of 2-level AxiaLIF procedures. In their review of 27 patients undergoing L4-S1 2-level AxiaLIF, only 22% of patients were considered to have solid fusion at 2 year follow-up.

Emerging MIS technologies were presented by a wide variety of groups. Regev et al. from Tel Aviv Sourasky Medical Center described the minimally invasive transforaminal, thoracic microscopic discectomy; Husain et al. from Loma Linda University described a percutaneous cervical transfacet fixation technique; Araghi et al. showed the results of the first 40 Guyer Lumbar Interbody Fusion (GLIF) procedures; MacMillan described a novel all transosseous approach to the L5-S1 disc, and both Julien (West Virginia University) and Sharma et al. (Manassas, VA) described the use of percutaneous stabilization for thoracolumbar fractures. It is heartening to see so many attempts to make the best of minimally invasive technology in this still pioneering area of spine surgery.

Santos et al. (University of Minnesota) showed that 3-D navigation may be used to improve safety and accuracy of percutaneous pedicle screw placement. Finally, the potential changes in healthcare delivery were highlighted by Smith and Christian (Las Vegas, NV) when they showed that selected MIS fusions may be performed in the ambulatory setting.

The diversity of topics was matched only by the excitement surrounding them. I’m looking forward to even more fascinating research by my colleagues at ISASS13 in Vancouver.

Choll Kim, MD, PhD
Spine Institute of San Diego

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.”

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.