Kategorie: joimax® News

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

Veröffentlicht am von christine.stump@joimax.com

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® 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

Veröffentlicht am von christine.stump@joimax.com

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.illu-multizyte-si-intracs-joimax_web

“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.

Eurospine 2016: joimax® launches its new MultiZYTE® SI-Joint Endoscopic Therapy Set and its new Intracs® Intraoperative Navigation Tracking & Control System

Veröffentlicht am von christine.stump@joimax.com

Karlsruhe – October 05, 2016 – joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, will again exhibit at Eurospine 2016 taking place from October 5 – 7 in Berlin. During the conference, joimax®will launch two new products – the MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy Set and its new Intracs® Intraoperative Navigation Tracking & Control System.

multizyte-si-treatment

MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy is developed for the treatment of the Sacroiliac Joint Syndrome (SIJS), which has been rediscovered as a major back pain generator in recent years. This kind of pain is commonly felt in the lower back, the gluteal region, the hip and thigh and can even radiate into the leg and foot. Until the 1930s, SI-Joint was the main reason for low back pain, but since 1934 the focus has been on disc herniation. According to recent studies 15 to 25% of all low back pain is caused by the SI-Joint and up to 43% in patients having undergone lumbosacral fusion. MultiZYTE® SI joimax® now offers a well developed and lasting treatment option for this disease.

joimax_broshure_intracs_fiagon_titel

joimax® Endoscopic Tower with Intracs® Navigation and Monitor Unit - not yet FDA cleared
joimax® Endoscopic Tower

The Intracs® Intraoperative Navigation Tracking & Control System was developed in cooperation between joimax® GmbH Karlsruhe and fiagon GmbH in Berlin, both located in Germany. With the Intracs® system, joimax® instruments can be navigated directly at the tip using Fiagons “chip at the tip” technology which allows tracking of instruments with a diameter in the 1mm range. The Intracs ® Navigation and Monitor Unit is integrated in the joimax® Endoscopic Tower and all necessary tools are tailored for the TESSYS® (transforaminal) and iLESSYS® (interlaminar) procedures as well as for minimally invasive stabilization procedures, like EndoLIF® and Percusys®. The main features of the Intracs® system are needle navigation through Vector-Tip-Target processing tools, the merging of 2D X-Rays with 3D- images of a patient’s CT or MRI scans, and the constant orientation control of any endoscope used in joimax procedures.

“With these two new developments we are in the position to enhance our endoscopic minimally-invasive product portfolio, driving adoption rates to meet new heights. With the world unique Intracs® system, navigation is now faster, safer and more accurate than ever before using an electromagnetic (EM) field. Radiation exposure for both, patients and surgeons will be significantly reduced,” says Wolfgang Ries, CEO and founder of joimax®. “Additionally the learning curve for all spinal endoscopic procedures offered by joimax® will now be significantly reduced and the rapid expansion of all these techniques is now well layed-out,” he continues.

JOIMAX® ANNOUNCES RELEASE OF FIRST ENDOSCOPIC AMA CPT CODE Company also releases newly designed joimax® homepage

Veröffentlicht am von christine.stump@joimax.com

Irvine, CA – September 26, 2016 – The AMA (American Medical Association) released the CPT 2017 Codebook (Current Procedural Terminology), now containing the first endoscopic spinal surgery code no. 62380. This new code covers endoscopic decompression of the spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar, and will be enforced as of January 1st, 2017. Under this code the specific transforaminal (TESSYS®) and/or interlaminar (iLESSYS®) procedures are fully covered in the USA herewith, which are already marketed by joimax® in 45 countries.

“The definition of this new code in the CPT codebook 2017 is a major milestone towards the acceptance of endoscopic minimally invasive spine surgery techniques and its benefits to both the surgeon and their patients,” states Wolfgang Ries, Founder and CEO of joimax®. Since 2012 joimax®  had been driving this effort to obtain CPT codes as these procedures required submission to payors for reimbursement coverage which was granted only in single cases under temporary codes, so-called T-codes.

“joimax® has been instrumental in driving the effort to obtain full code coverage of endoscopic spinal surgery,” says Daniel Laich, DO, Swedish Convenant Hospital, Chicago, who had been participating and presenting in almost every AMA meeting over the last five years. Due to the high research and publication activities by key users like Albert Telfeian, MD, PhD, at Rhode Island Hospital at Brown University, and a group of users around him, strong evidence has been accepted by AMA authorities, justifying the release of this new CPT code.

Many papers and publications on joimax® products can now be downloaded from the newly released joimax® homepage. The completely redesigned website offers visitors richer insight into the company’s innovative products and systems. A quick and easy access to essential information and features is available, including the latest workshop and education activities, which are essential in endoscopic minimally-invasive spinal surgery.

Meanwhile joimax® offers basic and advanced workshop training courses mainly in the USA, Germany and Austria, and oversees a participation population of almost 3,000 physicians. Independent training courses are also performed in China and Korea to support the fast growing Asian markets. Detailed information about those courses are updated regularly at www.joimax.com.

The website uses the latest technology so the site is compatible with today’s browsers and mobile devices, such as smartphones and tablets. Visitors can also use the new website to stay informed with the latest company news. The new website goes live today and is located at the same address: https://www.joimax.com.

joimax® STUDIES PUBLISHED IN WORLD NEUROSURGERY TESSYS® system proves to be surgical rescue solution for kyphoplasty complication and thoracic disc herniation.

Veröffentlicht am von christine.stump@joimax.com

Irvine, Germany, September 14th, 2016 – joimax®, the expert in endoscopic minimally invasive spine surgery, is pleased to announce another publication on its technologies to be released in World Neurosurgery (2016). In the paper called “Transpedicular Lumbar Endoscopic Surgery for Highly Migrated Disc Extrusions, a preliminary series and surgical technique,” published by Krzok G et al, 21 patients underwent this procedure with the TESSYS® system. The paper follows two technical notes by Wagner R et al in which he shows joimax® techniques as surgical rescue solutions in a kyphoplasty complication and another one for the treatment of a thoracic disc herniation, all published in World Neurosurgery.

The first technical note mentioned above describes the case of a 72-year-old woman with a leakage of the kyphoplasty cement into the spinal canal (a described and known complication), where the joimax® technology was successfully used as a rescue solution to remove the cement and decompress the nerval structures preventing major surgery. The second technical note describes the transforaminal endoscopic foraminoplasty and discectomy for the treatment of a thoracic disc herniation. A 31-year-old woman with severe thoracic back pain over one year was successfully treated by using the transforaminal endoscopic approach so that open surgery was not needed.

Over the years a growing number of studies show the outstanding advantages of endoscopic minimally invasive spinal surgery, such as the prospective Randomized Controlled Trial (RCT) of Ruetten et al in 178 patients and by Hoogland et al in a study of 262 consecutive cases of transforaminal endoscopic spinal surgery. Both were published in Spine 2008, Vol. 33, Issue 9. Another retrospective evaluation with 195 patients of Jasper et al (Clinical Neurology & Neurosurgery 2013, Vol. 115, Issue 10) and a multi-centric MIS prospective registry published by Sclafani et al (IJSS 2015, Vol. 9, Art. 69) with 86 patients, also showed very encouraging results. Beyond that, a special edition in the Journal of Neurosurgery called Neurosurgical Focus, published by Gokaslan Z, Telfeian A and Wang M focused on Endoscopic Spine Surgery was released in February 2016 (JNS 2016, Vol. 40, No. 2).

“Working with Endoscopic Spine Surgery for more than 12 years (her performed already 2,400 Tessys® procedures in daysurgery in analgo-sedation) and seeing its evolution is just amazing and I wonder where we will be in five or ten years from now”, says Menno Iprenburg, MD from Veenhuizen, NL, who continues to be involved in many of these studies.

Albert Telfeian, MD, PhD from Brown University, RI is very happy about the actual hit rate on PubMed when searching for endoscopic spinal surgery, “To date we’ve received a rate of 2,730 papers on http://www.ncbi.nlm.nih.gov/pubmed/?term=endoscopic+spinal+surgery and I am really excited how many indications are treatable with endoscopy already today,” said Telfeian.

“Shortly another RCT study will be published by Gibson et al demonstrating the quality and great success rate of endoscopic spine treatments with a high adoption rate, especially in Asian countries, and in some countries where there is more than 50% growth per annum”, says Wolfgang Ries, founder and CEO of joimax®.

CMS Includes Endoscopic Spine in Fee Schedule Proposed Rule for CY 2017

Veröffentlicht am von christine.stump@joimax.com

Baltimore, MD – July 14, 2016– The Centers for Medicare & Medicaid Services (CMS) recently released the proposed rules for the 2017 Medicare Physician Fee Schedule (MPFS) and the 2017 Hospital Outpatient Prospective Payment System (HOPPS). Both proposed rules provide information on physician and hospital payment for the newly created CPT code 630X1 for endoscopic decompression of the lumbar spine.

“This is a great step towards the acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to news_2016_reimbursement_Pic1both the surgeon and their patients in the U.S.,” said Wolfgang Ries, Founder and CEO of joimax®. This announcement is in alignment with the reimbursement decision of NICE, UK, in April of 2016, to fully reimburse endoscopic procedures.

A key reason for the recent momentum for endoscopic, minimally invasive spinal surgery is the significant, favorable base of literature, which validates evidence of the efficacy of endoscopic minimally invasive spine surgery. A special edition, “Neurosurgical Focus”, published by the Journal of Neurosurgery (JNS) in February 2016, contains a range of studies on endoscopic spine surgery.

picture

joimax® hosts symposium at WCMISST; presents Kambin Award to German Surgeons

Veröffentlicht am von christine.stump@joimax.com

Karlsruhe, Germany – June 9, 2016 – joimax®, the global developer and marketer of technologies and treatment methods for minimally invasive endoscopic spinal surgery, recently hosted an educational symposium and exhibit during the 5th World Congress of Minimally Invasive Spine Surgery & Techniques (WCMISST), held June 1-4, in Jeju Island, Korea. The World Congress, which takes place every two years, is attended by more than 500 physicians and is recognized as one of the most important congresses for minimally invasive spine surgery.

Additionally, joimax® hosted an educational symposium for spine surgeons from across the globe. ”About 200 attendees gathered to learn about the techniques of endoscopic minimally invasive spine surgery and the benefits of these techniques to both the surgeon and their patients,” said Wolfgang Ries, founder and CEO of joimax®. During the Congress’ Gala Dinner, joimax® had the honour of presenting the Parviz Kambin Award to Dr. Guntram Krzok and Dr. Ralf Wagner, both from Germany, for their excellence in endoscopic spinal surgery. The Parviz Kambin Award is presented to pioneers in the field of endoscopic minimally invasive spine surgery. Nominees are selected by SMISS, WCMISST and joimax®.

Dr. Guntram Krzok, owner of a private practice in Friedrichsroda, Germany, has performed more than 3,000 endoscopic and transforaminal surgeries since 1999 and has provided training at 100 workshops. He was the first surgeon to introduce the TESSYS® technique in China and routinely publishes about his growing experience in the field.

Since 2007, Dr. Ralf Wagner, from the Ligamenta Spine Center in Frankfurt, has performed nearly 2,700 endoscopic surgeries with transforaminal, interlaminar and cervical systems, as well as endoscopic assisted stabilization with the joimax® EndoLIF® technique. He, too, has provided training at nearly 100 workshops, is an active speaker at international congresses and has published numerous scientific articles.

The Kambin Award, named after Dr. Parviz Kambin, was originally presented to Dr. Kambin (Philadelphia, PA) by the Society for Minimally Invasive Spine Surgery (SMISS) and joimax® at meeting held in April of 2011 in Denver, CO. Previous award recipients include: Dr. Michael Schubert (Munich, Germany), Dr. Menno Iprenburg (Veenhuizen, the Netherlands), Dr. Anthony Yeung (Phoenix, AZ), Dr. Florian Maria Alfen (Würzburg, Germany), Dr. Daniel Laich (Chicago, IL), Dr. Gabriele Jasper (Brick, NJ), Dr. Albert Telfeian (Providence, RI) and Dr. Sang-Ho Lee (Seoul, Korea).

joimax® hosts SpineWeek symposium, leads live surgery broadcast during CAOS-NASS

Veröffentlicht am von christine.stump@joimax.com

Karlsruhe, Germany and Singapore, Chengdu/Shanghai, China (May 25, 2016) – joimax®, the global developer and marketer of technologies and treatment methods for minimally invasive endoscopic spinal surgery, recently hosted an educational symposium and exhibited at SpineWeek in Singapore. SpineWeek takes place every four years and is viewed as one of the most important congresses, representing numerous international society leaders.

“The decision to participate in this congress was the right step to demonstrate our presence in the Asian region,” says Wolfgang Ries, CEO and founder of joimax®. “This year, there was a clear focus on endoscopic treatments by the participating societies, which created a strong interest in our lunch symposium. Approximately 200 attendees gathered to learn about the techniques of endoscopic minimally invasive spine surgery and the benefits of these techniques to both the surgeon and their patients,” continued Ries.

To further validate the company’s expansion and presence in China, joimax® participated in the 9th Congress of the Chinese Association of Orthopaedic Surgeons – North American Spine Society (CAOS/NASS) meeting in Chengdu, China. The company was also involved with the Master Techniques in Spine Surgery Workshop, held on May 20, 2016 in Shanghai, China. Dr. Ralf Wagner, of the Ligamenta Spine Center in Frankfurt, Germany, led the technique-focused workshop and surgery, which was broadcast live to the meeting in Chengdu, as well as online to 30,000 Chinese surgeons.

joimax® turns 15 years

Veröffentlicht am von christine.stump@joimax.com

Karlsruhe, Germany and Chicago, Illinois (April 30, 2016) – joimax®, the global acting German developer and marketer of technologies and treatment methods for minimally invasive endoscopic spinal surgery, is celebrating its 15th anniversary worldwide in 2016 starting at AANS in Chicago combined with a joimax® Senior Faculty Meeting. The aim of this meeting is to share experience, deepen expertise, specifically in reference to the newest joimax® products and applications as well as to refine the specific surgical techniques. Key topics will be centered around endoscopic treatment of degenerative spine diseases.

“When I started with the TESSYS® system in 2006 I was wondering at which patient indications this system could be applied”, says Daniel Laich, DO at Swedish Covenant Hospital in Chicago, Il.
“Now we are doing all kind of special stenotic cases and even thoracic disc, or even tumor treatments”, continues Albert Telfeian, MD, PhD at the Hasbro Hospital of The Warren Alpert Medical School at Brown University, Rhode Island.
“With the iLESSYS® Delta System I can even do an over-the-top decompression in a central stenotic patient and with the EndoLIF® method I do an endoscopic assisted stabilization if indicated” finishes Ralf Wagner, MD from the Ligamenta Spine Center in Frankfurt, Germany.

joimax®, entirely focused on treatment technologies for endoscopic minimally-invasive spinal surgery, over the years launched more than 10 different indication driven systems providing a company growth rate of over 35% per annum. To date more than 180.000 patients had been treated in over 40 countries with the various methods, based on more than 140 patents and trademarks issued globally. “The major company growth and market evolutional steps are further out in front of the companies’ future, based on solid ground with broad market adoption starting just now”, states Wolfgang Ries, CEO and founder of joimax®.

NASS, 2015: joimax® launches its new EndoLIF® On-Cage and new iLESSYS® Delta interlaminar endoscopy system

Veröffentlicht am von christine.stump@joimax.com

Chicago, Illinois – October 14, 2015 (BUSINESS WIRE) – joimax®, the global German developer and marketer of technologies and training methods for minimally invasive endoscopic spinal surgery, launches its two newest products – the EndoLIF® On-Cage and iLESSYS® Delta interlaminar system, during the 30th annual North American Spine Society (NASS) meeting in Chicago.

“With the new EndoLIF® program, combined with the TESSYS® technology, and now the iLESSYS® Delta, joimax® offers complete endoscopic solutions for spinal decompression, stabilization and fusion.”

The EndoLIF® On-Cage is a 3D-printed titanium alloy, manufactured utilizing a special electron beam melting (EBM) technology. The cage displays a porous surface with a diamond cell structure, which provides an optimal base for cell proliferation and bone growth. Two large implant graft windows, which are filled with autogenous bone, allow for bridging bone to further support fusion. The EndoLIF® On-Cage implant allows surgeons to utilize a mini-open or an inter-muscular approach, similar to a mini-transforaminal lumbar interbody fusion (TLIF) approach, into the intervertebral disc space facilitating endoscopic-assisted fusion.

Dr. Ralf Wagner, LIGAMENTA Spine Center, Frankfurt, and Dr. Bernd Illerhaus, ONZ Spine Center, Recklinghausen, are two German spine specialists who have already performed more than 200 of the 800 EndoLIF® On-Cage procedures in Europe. “The access is dura and nerve-gentle, preserves better dorsal bony structures and limits scar tissue formation because of the stepwise tissue dilation,” said Dr. Wagner.

iLESSYS® Delta, an advanced development of the joimax iLESSYS® standard 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 a more widened interlaminar approach, guided by a full endoscopic direct visualization technique. The new and specific instrument set includes specially developed tools that permit an extensive, yet gentle, tissue-sparing decompression. A new endoscope with a 6 mm working channel allows the use of large shaver blades designed for bone and tissue resection, along with a range of instruments to be applied under full endoscopic view.

“We are impressed by the new endoscope which delivers outstanding image quality. With the specialized instrument set, it is finally possible to achieve decompression of central spinal canal stenosis,” said Albert E. Telfeian, M.D., Ph.D., Department of Neurosurgery, Rhode Island Hospital, Providence, RI. Jian Shen, MD, PhD, of Mohawk Valley Orthopedics, P.C., NY, concurs. The two surgeons gained experience with the new system during a meeting at the Anatomy Department of the University of Mainz, Germany, earlier this year, and during the cadaveric training course at Vitruvian lab in Baltimore, MD, held last week.

“Albert Telfeian and Jian Shen will be the first spinal surgeons in the USA to perform surgeries with the new iLESSYS® Delta endoscopic technology and the EndoLIF® On-Cage implants,” says Wolfgang Ries, CEO and founder of joimax®. He adds, “With the new EndoLIF® program, combined with the TESSYS® technology, and now the iLESSYS® Delta, joimax® offers complete endoscopic solutions for spinal decompression, stabilization and fusion.”

With the FDA approval of Percusys® percutaneous screw-rod-system earlier this year, and the FDA approval of EndoLIF® On-Cage in July, joimax® is positioning itself as a clear leader in minimally invasive endoscopic spinal surgery, providing a full spectrum of product technologies, now fully available in the U.S. market.