FDA approves IDE study for Premia Spine’s TOPS™ System

Posted On May 10, 2017 By OrthoSpineNews In Regulatory, Spine /

PHILADELPHIA, PENNSYLVANIA, UNITED STATES, May 8, 2017 /EINPresswire.com/ — Premia Spine, Ltd. announced today that it has secured FDA approval for its pivotal study of the new TOPS™ System.

“We are excited about the opportunity to provide U.S. patients with access to the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule,” said Ron Sacher, CEO of Premia Spine.

The new TOPS device, with a 30% smaller footprint and a simpler surgical technique from the original device, has been in commercial use in Europe for over 5 years.

The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS™ System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.

The study’s lead investigator is Dom Coric, Chief of Neurosurgery, at Carolinas Medical Center. Clinicians who have received approval or are in the process of securing IRB approval include Josh Ammerman and Josh Wind (Sibley Hospital), Neel Anand and Hyun Bae (Cedar Sinai), Steve DeLuca (Orthopedic Institute of Pennsylvania), Jason Huang (Baylor Scott & White), Armen Khachatryan (The Disc Replacement Center at Jordan Valley Medical Center), Andy Kranenburg (Providence Medford Medical Center), Scott Leary (Scripps Health), Ali Mesiwala (Southern California Center for Neuroscience and Spine), Kent New, Steve Pirris, Eric Nottmeier, and Ali Chahlavi (St. Vincent’s Medical Center), Pierce Nunley (Spine Institute of Louisiana), Rick Sasso (Indiana Spine Group), Bill Smith (Western Regional Brain & Spine), Don Whiting (Allegheny Health Network), Phil Yuan (Memorial Long Beach Hospital) and Jim Zucherman, Ken Hsu, and Dimitriy Kondrashov (St. Mary’s Medical Center). Other leading spine research centers are preparing their IRB submissions to join what will prove to be the one of the most watched spine studies.

Clinical sites will be measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the TOPS™ System versus traditional lumbar spinal fusion,” explains Mr. Sacher.

About Premia Spine. Premia Spine licensed the TOPS System technology in 2011 from Impliant, Ltd. Over $100 million has been invested to design, develop, and commercialize the TOPS System, with over 12 years of clinical use and 1,000 patients.

Ron Sacher
Premia Spine, Ltd.
ronsacher@premiaspine.com
email us here

Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications

Posted On May 9, 2017 By OrthoSpineNews In Regulatory, Spine /

May 09, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the FDA 510(k) clearance of the CRANIAL FUSION System. This clearance expands the indications for utilizing SOLSTICE Polyaxial Screws into the cervical spine.

“With the clearance of the Cranial Fusion System, this is an exciting opportunity for use of our Solstice system screws for posterior cervical fusions,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of posterior occipito-cervico-thoracic fixation of the spine, thus providing the highest value of care to our customers and patients.”

The CRANIAL FUSION System is a multiple component system comprised of titanium alloy, with a variety of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

SOLSTICE polyaxial screws used with the CRANIAL FUSION System come in 3.5, 4.0 and 4.5mm diameters. The conical polyaxial head angulation facilitates easy rod placement with minimal contouring, and the “friction head” feature maintains screw head position within the surgical wound.

In order to achieve additional levels of fixation, The CRANIAL FUSION System may be connected to the NAUTILUS^® Thoracolumbar Pedicle Screw System using the 3.5mm/5.5mm titanium parallel connectors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Medovex Corporation to Attend The NSpine Main Conference June 12-15, 2017

Posted On May 9, 2017 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – May 8, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it will attend The NSpine Main Conference June 12-15, 2017 in London.

The NSpine Main Conference takes place every two years to provide the latest knowledge for spine healthcare professionals. Growing in strength with each meeting, NSpine provides ascendant medical professionals with the supplementary material they need to forge best practice in their careers.

All areas of the meeting are covered comprehensively with parallel sessions being held to allow delegates to tailor their learning experience to their specific needs. Boasting cadaver sessions, workshops, seminars, lunch symposiums and an exhaustive list of lectures and exhibitions by leading practitioners and innovative companies, NSpine endeavours to cater to its delegates’ academic pursuit.

NSpine 2017 will take place in London, UK on June 12-15 and was developed in collaboration with the European Spine Journal, BioSpine, NASS and EANS.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “The NSpine show will be an excellent meeting venue to meet with key surgeons while we continue to prepare for our launch of the DenerveX System.“ Sablowski went on to say: “The UK market is very important to us since it will be a leading country for our initial entry into Europe once we receive the CE Mark. The Company will conduct both a cadaver lab and a workshop session with advisory board member and leading spine surgeon Dr. Vik Kapoor.”

The Company’s patented DenerveX™ System is not yet commercially available in the EU and the U.S. The DenerveX System is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

Medovex Corp.
Jason Assad
470-505-9905
Email Contact

Inspired Spine Presents on Groundbreaking OLLIF Procedure at International Spine Surgery Meeting

Posted On May 9, 2017 By OrthoSpineNews In Spine /

BOCA RATON, FLORIDA (PRWEB) MAY 08, 2017

Inspired Spine recently presented on the Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedure at the International Society for the Advancement of Spine Surgery (ISASS). Dr. Hamid Abbasi, who developed the OLLIF, discussed the revolutionary procedure that has been a dramatic improvement on existing spinal fusion techniques.

At the ISASS meeting April 12-14, 2017, Dr. Abbasi discussed the key findings of Inspired Spine’s study titled “Oblique Lateral Lumbar Interbody Fusion (OLLIF): Technical Notes and Early Results of a Single Surgeon Comparative Study”. The study compared the OLLIF procedure to an open transforaminal lumbar interbody fusion (TLIF) procedure.

Amazingly, the study of 124 patients showed surgery time for the OLLIF was approximately twice as fast as the open TLIF (mean: 135 min) and blood loss was reduced by over 80% compared to TLIF. The OLLIF surgeries were performed with biplanar fluoroscopy with an incision amounting to only one centimeter.

Inspired Spine has continued the data acquisition since the initial 124 patients, with over 500 OLLIF procedures now being performed nationwide. According to Dr. Abbasi “With the OLLIF procedure, we use a tiny incision and don’t cut through the patient’s muscle tissue like traditional procedures. The procedures are faster, have less blood loss and patients experience a dramatically faster recovery with less pain!”

Along with presenting at the meeting, Inspired Spine had two poster presentations as well. One on the Economic Performance of OLLIF and the other on the Minimally Invasive Direct Thoracic Interbody Fusion (MIS-DTIF). The OLLIF procedure saved the hospitals involved over $9500 per case compared to the open TLIF procedure due to the faster OR times and reduced length of stay.

The OLLIF procedure is available to patients nationwide with certified surgeons by calling (877) 378-2828. The full text of the studies is available by visiting http://inspiredspine.com.

About Inspired Spine

Inspired Spine, a Minnesota-based advanced minimally invasive spinal surgery technology developer, has introduced and performed over 500 procedures using revolutionary new technologies and procedures in advanced minimally invasive systems. These new procedures are transforming how spinal surgeries are approached and can replace more traditional “open” spinal fusion surgeries. Inspired Spine is focused on the development of advanced minimally invasive surgical techniques, procedures and other health care technology to minimize or eliminate the physical and economic risks and discomfort that are created by the daily struggles of enduring back pain and its physical limitations.

CONTACTS

For Inspired Spine
David Greene, MBA
(888) 378-2828
dgreene(at)theusleadnetwork(dot)com

Spinal Stenosis Implant Market Set to Witness an Uptick During 2017–2025: Persistence Market Research

Posted On May 8, 2017 By OrthoSpineNews In Spine /

New York, NY — (SBWIRE) — 05/08/2017 — Spinal stenosis is a condition which usually occurs in the elderly patients. Stenosis mean abnormal narrowing of a body channel. This mean spinal stenosis is narrowing of the spinal canal. The narrowing of spinal canal occurs due to degeneration of intervertebral disk and facet joint. This condition mainly affects people above 50 years but can also affect younger people who are born with abnormal spinal canal. If the narrowing is minimal symptoms will not occur but too much narrowing can lead to compression of nerves and can be problematic. Spinal stenosis symptoms include lower back pain, numbness in legs and balance problem. It can occur anywhere along the spine.

Increasing prevalence of spinal stenosis is one of the major factor driving the growth of spinal stenosis implant market. Other factors contributing to the growth of the market are increasing older population and rise in the obesity cases which can lead to spinal injury or stenosis. Increasing demand and adoption of the minimally invasive surgeries and better relief over the medication are also factors driving growth in this market.

Spinal stenosis implant market is expected to show significant growth over the forecast period. Increasing case of arthritis and ageing of the population is expected to be the factor facilitating the growth of spinal stenosis implant market. Spacing is devices are expected to be highest revenue generating and fastest growing product segment due to increasing demand for minimally invasive treatments as this procedure has lesser risks involved and also it allows easy movement in comparison to fusion or fixation devices which involves long surgical process and higher blood loss. Along with this spacing devices provide faster and lasting symptoms relief and has lesser hospital stay. Titanium spinal stenosis implants are expected to be fastest growing, and highest selling as titanium is strong and light in weight when compared to the stainless steel implants and it has better elasticity which allows easy movement. Ambulatory surgical units are expected to have the highest number of such surgeries as these units are being used for performing the minimally invasive surgeries and patients don’t need to stay overnight.

READ THE REST HERE

New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies

Posted On May 8, 2017 By OrthoSpineNews In Spine, Top Stories /

CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center for Disc Replacement at Texas Back Institute presented the adjacent segment disease (ASD) outcomes of the activL^® Artificial Disc Investigational Device Exemption (IDE) trial at the International Society for the Advancement of Spine Surgery Annual Meeting (April 12-14, 2017, Boca Raton, FL). The data reiterates the role of lumbar total disc replacement in delaying the progression of ASD, a common downstream complication associated with lumbar fusion. ASD furthers the societal burden imposed by degenerative disc disease, a condition responsible for 62 million physician visits per year and the number two reason – second only to the common cold – for lost work time. The trial found that at five years, the activL Artificial Disc had a protective effect on the progression of DDD at adjacent levels in 91.2% of patients.

According to Dr. Guyer, former president of the North American Spine Society (NASS), “These outcomes complement the large body of evidence already available reporting on the long-term adjacent outcomes following lumbar disc replacement. Previously, lumbar fusion had been reported to be responsible for a rate of ASD as high as 28.6% in patients with five-year follow-up.”

In 2008, Harrop et al. published a systematic review of lumbar disc replacement data and reported that in patients with three to 22 years of follow-up, total disc replacement resulted in a 9% adjacent segment degeneration rate, whereas lumbar fusion resulted in a 34% rate. Later, in 2012, Zigler et al. worked with Medical Metrics Incorporated (MMI) to conduct a post-hoc analysis on ProDisc-L IDE subjects and found a three-fold reduction in ASD rates between lumbar TDR and fusion at five years. MMI employed the same methods used in Zigler et al., 2012 to analyze the ASD outcomes from the activL Artificial Disc IDE trial.

Until recently, patient access to lumbar arthroplasty, or total disc replacement, for patients suffering from symptomatic degenerative disc disease has been a challenge due to the lack of coverage on many insurance policies. However, outcomes such as those presented by Dr. Guyer have caused payers to reconsider their policies.

In May, national insurer Humana, which is responsible for insuring more than six million American lives, overturned their coverage determination for lumbar total disc replacement. This policy change, along with others, resulted in now nearly one in two privately-insured Americans having access to lumbar disc replacement. Additional long-term evidence will likely cause more payers to reconsider their stance in the coming months.

A group of surgeon investigators from the activL Artificial Disc IDE trial are currently compiling the full outcomes of this ASD analysis and are expected to seek publication of the full data set later this year.

SOURCE Aesculap Implant Systems, LLC

SI-BONE, Inc. Announces U.S. Military’s TRICARE Now Covers MIS SI Joint Fusion

Posted On May 8, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., May 8, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that TRICARE has established a written coverage policy for minimally invasive SI joint fusion surgery. TRICARE is a regionally managed health care program for active duty and retired members of the uniformed services, their families, and their survivors. The policy provides coverage for the 9.4 million members of the United States military’s health care system, including access to 55 military hospitals and 373 military clinics, and states that “minimally invasive surgery (CPT^® procedure code 27279) for the treatment of sacroiliac joint pain is proven.” The positive coverage policy is retroactive to August 23, 2016 and was established based on the high quality prospective clinical evidence published on the iFuse Implant^TM.

“It gives me great pride to announce that the iFuse Procedure^TM is considered a proven treatment by the United States Defense Health Agency and can now be appropriately offered to active and retired military personnel and their family members,” said Michael Mydra, SI-BONE’s Vice President, Health Outcomes & Reimbursement. “SI-BONE is pleased to be able to help all the brave men and women in our armed forces for their service to our country.”

“Earlier this year, we met with Colonel Stephen C. Phillips, DO, MPH and his staff at the Defense Health Agency in Washington, D.C. and reviewed the extensive published clinical evidence for the iFuse Implant. Following that meeting, the TRICARE policy team determined that coverage for MIS sacroiliac joint fusion was appropriate and warranted,” said Tony Recupero, Chief Commercial Officer at SI-BONE. “We are now fully engaged with physicians at military facilities across the country to assist them in providing iFuse to appropriately diagnosed military personnel.”

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁵ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant^TMwas designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

CPT copyright 2017 America Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.

1.	Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
2.	Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3.	Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4.	Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5.	DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Titan Spine Appoints Spine Industry Expert Ed Graubart as Vice President of Professional Development

Posted On May 8, 2017 By OrthoSpineNews In Spine /

May 08, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced Ed Graubart has joined the leadership team as Vice President of Professional Development. Mr. Graubart will be responsible for enhancing and building the Company’s infrastructure for training and professional development at Titan Spine as demand accelerates for its nanoLOCK® surface technology, the only nano-cleared interbody device on the market shown to elicit a nano-cellular level response for bone growth.¹

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Ed is a highly accomplished veteran of the orthopedic medical device industry, with more than 27 years of sales team infrastructure and personnel building experience at leading spine companies including NuVasive, DePuy Spine, and EBI. We are excited to have such a highly regarded leader join our Titan Spine team and we look forward to Ed’s contributions to enhance and build the infrastructure for training and professional development during a time of tremendous growth and momentum at Titan Spine as demand accelerates for both our original Endoskeleton® surface technology implants and the recently introduced interbody systems with our unique and proprietary nanoLOCK^®technology.”

Mr. Graubart added, “Titan Spine’s nanoLOCK® technology is aggressively paving the way for devices to create an osteogenic response in the spine interbody device industry. The Company has recently shifted into a critical period marked by scaling up to manage its substantial growth over the last few years, achieving record sales for the first quarter of 2017, increasing the number of nanoLOCK® surgeon adopters across the U.S., and significantly increasing sales volume of nanoLOCK® since launch in the fourth quarter of last year. I am immensely excited to join the Titan team and look forward to supporting this drive and energy through all aspects of the organization, including tailoring training programs and aligning structure to support our growth and success.”

Mr. Graubart joins Titan Spine from Ceterix Orthopaedics, a developer of novel surgical tools that improve a surgeon’s ability to perform meniscal repairs, where he served as Vice President of Sales. Prior to Ceterix, Mr. Graubart spent 10 years in leadership and executive sales and sales training positions at NuVasive, supporting the company’s growth from $38 million in 1995 to over $800 million in 2015. Before this, Mr. Graubart was Director of Spine Arthroplasty at DePuy Spine, Inc. where he was part of an elite team hired to train and support the introduction of the first lumbar artificial disc approved in the United States. Mr. Graubart started his career in orthopedic and spine medical device sales in 1992 with EBI Medical Systems (A Biomet Company), where he spent 14 years in various sales and leadership roles during his tenure. Mr. Graubart received his B.S. in Business Administration and Marketing at the University of Dayton.

Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary nanoLOCK^® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

Scopis Introduces the First Mixed-Reality Surgical Holographic Navigation Platform Integrating Microsoft HoloLens

Posted On May 5, 2017 By OrthoSpineNews In Spine /

May 05, 2017

CAMBRIDGE, Mass. & BERLIN–(BUSINESS WIRE)–Scopis, a company specializing in surgical navigation and medical augmented and mixed reality technologies, announced today the launch of its newest development, the Holographic Navigation Platform for use in surgery. Scopis developed this platform to offer greater precision and speed to surgeons, and better outcomes to patients undergoing open and minimally-invasive spinal procedures. The added innovation of incorporating Microsoft HoloLens into the Scopis Navigation Platform lets surgeons plan the positioning and alignment of pedicle screws during multiple vertebrae fixation surgeries, for example.

To use the Scopis Holographic Navigation Platform during such an operation, the surgeon wears Microsoft HoloLens glasses, which communicate wirelessly with the Scopis system. The planned positioning of the pedicle screws is projected onto the surgeon’s field of view and overlaid exactly onto the patient, creating the mixed reality experience. This allows the surgeon to find the screws’ planned positions faster and to align surgical instruments interactively with the holographic visualization.

“Scopis’ holographic solution has the potential to make spine surgery more effective, safe, and precise,” said Professor Christian Woiciechowsky, Chief of the Spinal Surgery Clinic at Vivantes Humboldt Hospital in Berlin. “Integrating mixed-reality tools into surgery is a huge technological advancement toward enhancing a surgeon’s vision and may provide greater benefits to patients.”

Scopis’ technology improves the accuracy of mixed reality overlay using additional 3-D position tracking. The Scopis holographic platform revolutionizes surgical workflows by enabling surgeons to use gestures to place virtual monitors into their visual field near the patient, so their eyes remain on the operative field. A video demonstrating the platform’s technological advantages is featured on Scopis’ YouTube channel: https://www.youtube.com/user/ScopisMedical/

Scopis’ technology could also benefit patients and medical professionals by reducing the radiation exposure from fluoroscopy devices that are currently used to determine the optimal position for screw placement during surgery, as well as improve surgical outcomes through more precise alignment and shorter surgery times.

“Scopis’ Holographic Navigation Platform is a universal solution that offers specific advantages for spinal surgeries and can also be applied in the many other areas where the highest levels of precision and speed are critical. In neurosurgery, for example, brain tumors could be located faster and with higher accuracy,” said Bartosz Kosmecki, CEO and Founder of Scopis. “The development of this holographic platform further highlights Scopis’ leading role in medical mixed and augmented reality.”

About Scopis

Scopis is a leader in medical augmented reality (AR), mixed reality, and hybrid navigation, creating innovative solutions for the healthcare market, including technology for surgical education, and planning and navigation systems for otorhinolaryngology (ENT), craniomaxillofacial (CMF), neuro- and spine surgery, and bronchoscopy. In over 50 countries worldwide, surgeons have performed more than 10,000 surgeries with the aid of Scopis’ products and have benefitted from the highly-advanced image guidance and visualization capabilities of Scopis’ technology.

Scopis is known as one of the top vendors and innovators for surgical navigation systems and has business operations in Germany and the United States. www.scopis.com

For Visual and Multimedia Representations of Scopis’ Products:

http://holographic.scopis.com

http://www.scopis.com

https://www.youtube.com/user/ScopisMedical/

Regional availability. Not all Scopis products are available for sale in the United States.

Contacts

Scopis:
Bartosz Kosmecki
CEO & Founder
(+1) (512) 578-9127
pr@scopis.com
or
Media Contact:
MacDougall Biomedical Communications
Joanne Tudorica or Gretchen Schweitzer
+49 89 2424 3494 or +49 176 210 37191
jtudorica@macbiocom.com
For Commercial and Surgical Inquiries:
Scopis Inc.
inquiries@scopis.com

VTI has Partnered with Medikon to Distribute Its InterFuse® Products in Turkey

Posted On May 5, 2017 By OrthoSpineNews In Spine, Top Stories /

(PRWEB) MAY 04, 2017

VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has partnered with the Turkish Medical Distribution company Medikon to distribute its InterFuse® product line in Turkey. Medikon will serve as an extension to VTI to meet the growing demand of high quality spinal fusion products in Turkey.

“We are excited to start working with Medikon, the company has been serving the Turkish spine surgeon community since 1995 with highly differentiated products and I’m convinced they will do an excellent job selling the InterFuse® product line,” says VTI’s Vice President of International Sales Ben Wasscher.

Sinan Kazmaci Managing Director of Medikon stated, “At Medikon we are excited to be working with the InterFuse® modular cage. When we presented the product to our most important surgeons, there was a great deal of enthusiasm and excitement for the product. Surgeons thought that the modular approach to achieve a large footprint through a small access channel was a great idea and many of them are keen to start with InterFuse®, especially for their more challenging patients.”

ABOUT MEDIKON
Medikon Ltd. Was founded in 1995, and is active in the field of spinal surgery, neurosurgery and orthopedic surgery products. Medikon is the foremost distributor of unique spinal products manufactured by some of the world’s leading companies. The company employs close to 100 people operates with 7 branches and 15 dealers all over Turkey including Ankara and İstanbul. Learn more about Medikon here: http://www.medikon.net/

ABOUT VTI’S INTERFUSE® SPINAL FUSION SYSTEM
VTI’s InterFuse® System is an intra-operative assembly technology, which allows surgeons to implant a large footprint device through a minimally invasive approach. The shape of each device is biomechanically optimized to match the contours of the endplate and the unique anatomical shape and size of each patient’s disc space. Learn more about VTI’s InterFuse product here: http://www.vti-spine.com/product/interfuse/

ABOUT VTI – VERTEBRAL TECHNOLOGIES, INC.
VTI – Vertebral Technologies, Inc. is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse® modular interbody fusion devices worldwide. Learn more about VTI here: http://www.vti-spine.com/

For more information, visit: http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or + 1.877.912.5401.