AMDT Holdings, Inc. Gains FDA Clearance for the SixFix™ System

Posted On September 14, 2018 By OrthoSpineNews In Extremities, Regulatory /

COLLIERVILLE, Tenn., Sept. 5, 2018 /PRNewswire/ — AMDT Holdings, Inc. (AMDT) is pleased to announce FDA clearance for their patented SixFix deformity analysis and correction software and instrumentation. AMDT Holdings, Inc. develops new products to address the existing and emerging needs of the multi-billion-dollar extremity medical device market.

Spatial frame fixators usually consist of two rings connected by six adjustable connectors called struts. This type of construct can also be referred to as a hexapod. Fixation elements connect the rings to bone fragments; small, simultaneous changes in the lengths of multiple struts alter the alignment of the bone fragments in relation to one another. Currently, surgeons manually measure and input values, many derived from patient radiographs, into optional software to create a prescription consisting of daily adjustments over a period of weeks or months. The end result is a corrected deformity and a healed fracture.

The SixFix system, which is indicated for use with the Smith & Nephew Taylor Spatial Frame®, dramatically reduces the time and effort involved in manual input of measurements and their values as required by currently available alternatives, and generates a prescription defining the incremental strut adjustments that will ultimately correct the deformity.

With the SixFix system, the surgeon attaches the system’s six radiopaque fiducial markers to the rings of a spatial frame external fixator, and inputs readily available spatial frame characteristics, such as ring diameter, strut length and axial rotation, into the SixFix software. This information is used to graphically map the deformity with line segments that define the axes of the bone fragments. The software utilizes sophisticated algorithms to correct imperfections present in all radiographs, such as variable magnification and perspective distortion, in the process of creating a precise 3-D replica of the frame and the deformity. SixFix software offers the surgeon options to specify waypoints, customized treatment milestones that the surgeon uses to set the order and duration of each correction.

“This is truly a medical innovation that can offer advantages to both my patients and me,” says Paul Freudigman, M.D. An orthopedic surgeon in the Dallas-Fort Worth, TX, area who has treated patients with spatial frames for almost 20 years, Freudigman is eager to utilize the SixFix technology. “The reduction in time and effort to generate a deformity correction prescription using SixFix is remarkable. Even more exciting will be to assess how much the image correction capabilities of the software can improve my outcomes.”

Stephen J. Frania, DPM, FACFAS, a surgeon in Mentor, Ohio, who specializes in reconstructive foot and ankle surgery including lower limb deformity correction, says, “Of all the advantages offered by the SixFix software, time-savings is one benefit that I will realize right away.” He goes on to explain, “The current devices require a great deal of time and manual effort during my clinic hours to measure and record the data necessary to describe the frame and the deformity as represented by their radiographs. I bring these patients in weekly to evaluate the progress of their correction. The time I save and the improved accuracy when using the SixFix software is significant over these repeat visits.”

Samir Mehta, M.D., Chief of Orthopaedic Trauma and Fracture Service for the University of Pennsylvania Health System, who is at the forefront of fracture fixation and deformity correction, also expresses interest in the benefits the SixFix system provides. “The intuitive, graphical nature of the SixFix software reduces my time and effort when treating a deformity. In addition, it works with one of the devices I currently use. The end result is a deformity correction prescription requiring surprisingly little manual input and time.”

The SixFix system was developed under the direction of Michael Mullaney, VP of Product Development at AMDT Holdings, Inc., who created the web-based implementation of the forward kinematic solution that solved the challenge of the crooked frame on a crooked bone when the Smith & Nephew Taylor Spatial Frame® was first widely used. In reference to the SixFix system, Mullaney says, “The six radiopaque markers provide full descriptive positional data to the SixFix software that enable it to create an accurate 3-D replica of the frame and deformity regardless of how the radiographic images were taken. The SixFix is a far more powerful and accurate tool than my prior deformity correction application as well as more intuitive, faster and easier-to-use.”

Patrick Mullaney, President and CEO of AMDT Holdings, Inc., has also been involved in this segment of orthopaedic devices since its inception in the mid-1990s. “While the SixFix software represents significant advantages in ease-of-use to the surgeon, these major benefits will be compounded with the introduction of a truly innovative hexapod that is currently in development. Initial test results of the hexapod are impressive. We plan to submit this 510(k) application to FDA shortly.”

Since its inception in 2016, AMDT has been focused on designing, validating and commercializing innovative devices to address challenges faced by surgeons treating fractures and correcting deformities. Headquartered outside of Memphis in Collierville, Tennessee, AMDT also commercialized the AMDT Mini-Rail Fixator in early 2017, a modular unilateral external fixator that provides versatile fixation for simple or complex trauma, deformity correction and lengthening procedures. Arrowhead Medical Device Technologies, LLC, the sister organization to AMDT, was founded in 2010 to commercialize the patented ARROW-LOK® Digital Fusion System. Designed to effectively correct digital deformities of the foot, it has the distinction of being the world’s tiniest intramedullary nail. To learn more about AMDT, SixFix and the AMDT Mini-Rail Fixator, please visit www.AMDTHoldings.com. The ARROW-LOK can be viewed at www.ArrowheadDevices.com.

SixFix is a trademark of AMDT Holdings, Inc.
ARROW-LOK is a registered trademark of Arrowhead Medical Device Technologies, LLC.
Taylor Spatial Frame is a trademark of Smith & Nephew, Inc.

View original content:http://www.prnewswire.com/news-releases/amdt-holdings-inc-gains-fda-clearance-for-the-sixfix-system-300707520.html

SOURCE AMDT Holdings, Inc.

CoreLink Surgical, LLC, Today Announced 510(k) Clearance to Market the M3™ Stand-Alone Anterior Lumbar (ALIF) System

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine /

September 11, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical, LLC, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the M3™ Stand-Alone Anterior Lumbar (ALIF) System.

Jay Bartling, CEO, said, “M3 is our first stand-alone interbody fusion device to feature 3D printing – I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products.”

The M3 system is a sterile packed, 3-screw, integrated fixation device for ALIF procedures, featuring a universal bi-directional design with a simple and intuitive locking mechanism. M3 was also developed utilizing CoreLink’s proprietary Mimetic Metal™ technology and features unique patent pending StrutSure™ technology, which creates a combination of load-sharing support structure and interconnected lattice minimizing material density for imaging.

With this new clearance, the CoreLink 3D printed ALIF portfolio, both Foundation 3D ALIF and M3™ ALIF, feature the largest footprint size available on the market, allowing for additional options to accommodate an ideal anatomical fit. “I’m always in pursuit of sizing cages to capture as much of the cortical ring that borders the endplates as possible. A larger cage option allows me a more appropriate fit for some patients. Additionally, a larger cage can be helpful for greater surface contact with the endplates, which can enhance stability for a higher likelihood for fusion,” said Neurosurgeon, Justin L. Owen, MD, FAANS (Slidell, LA).

“Our R & D team concentrated on creating a product that would feature our additive manufacturing capabilities, while also streamlining procedural efficiency. We’re extremely proud of the unique universal instruments offered with M3,” said David Castleman, VP of Research and Development for CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where a full display of the Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

www.corelinksurgical.com

(Photo: Business Wire)

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808

Captiva Spine Announces TowerLOX-EXT® MIS Extended Tab Pedicle Screw Receives Clearance

Posted On September 11, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Jupiter, FL, September 2018 – Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine fusion solutions announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market TowerLOX-EXT® MIS Extended Tab Pedicle Screw complementing its TowerLOX® MIS Pedicle Screw System.

TowerLOX-EXT MIS Extended Tab Pedicle Screw

TowerLOX-EXT MIS Extended Tab Pedicle Screws provide the narrow insertion of an extended tab pedicle screw and the versatility, reliability, and security of a tower-based MIS pedicle screw. TowerLOX-EXT’s narrow insertion path coupled with TowerLOX’s patented articulating rod delivery/reduction options expand the capabilities of the system. Most notably, TowerLOX-EXT allows percutaneous tower attachment after the extended tabs have been removed, establishing a new standard for MIS pedicle screw systems. This is especially important intraoperatively, or for use when extending the fusion at a later date.

Dale Mitchell, President of Captiva Spine, stated “The design rationale and goals developed with our surgeon collaborators guided the creation of TowerLOX-EXT Extended Tab Pedicle Screw. Our intent was to reduce insertion pathway, eliminate counter-torque wound expansion, and retain the versatility provided by TowerLOX’s unique instrumentation for rod delivery, rod reduction, and spondylolisthesis reduction.”

TowerLOX® MIS Pedicle Screw System already supports MIS, mini-open, and open cases with simple and less invasive rod insertion (using patented Pivotec® Technology) and efficient internal/external rod reduction. TowerLOX-EXT screws provide 15mm of controlled built-in rod reduction above the break-off and in-situ tower attachment capabilities provide a MIS rescue/revision option not available with other extended tab systems.

Captiva Spine’s TowerLOX-EXT MIS Extended Tab Pedicle Screw is one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality. They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

SEE MORE ABOUT TOWERLOX-EXT

This Press Release can be found at PRWeb.com and is also featured on other industry sites.

Amedica Announces Filing of Key Patent Application Relating to the Anti-Viral Effect of its Silicon Nitride

Posted On September 10, 2018 By OrthoSpineNews In Regulatory, Top Stories /

SALT LAKE CITY, Sept. 10, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced the filing of a U.S. patent application for breakthrough research findings that have identified a new property of its proprietary silicon nitride.

Amedica investigators led by Dr. Giuseppe Pezzotti, a professor at the Kyoto Institute of Technology (Japan) and consultant to Amedica Corporation, have developed micromeritic silicon nitride powders as well as bulk surfaces that are effective against several strains of commonly prevalent viruses – including Influenza A virus (H1N1), the virus responsible for the 2009 flu pandemic. The research has also identified the surface chemical properties of silicon nitride that contribute to the observed virucidal effect.

The mechanism, known as alkaline transesterification, is known to cause genomic cleavage in active viruses leading to their inactivation and lysis. The investigation employed a commonly accepted assay of measuring mammalian cell viability in the presence of high concentrations of virus particles. In the case of Influenza A virus, a 5-minute exposure to Amedica’s silicon nitride either at room temperature or at 4^oC was enough to result in complete virus lysis and inactivation such that 100% of the exposed cells survived. In an identical parallel test conducted without silicon nitride, the virus remained intact and was able to infect and destroy exposed cells. Silicon nitride proved to be an effective disinfectant of the virus thus providing a protective effect to cells exposed to the virus.

“These unexpected results are of course entirely welcome, and the remarkable discovery opens new frontiers in our evolving understanding of silicon nitride as a biomaterial and in practical applications of it,” said Dr. B. Sonny Bal, Chairman and CEO of Amedica Corporation. “The discovery is particularly timely given our recent divestment of the retail spine business to CTL Medical and our transition to an OEM manufacturer and biomaterials company.”

“From the standpoint of spine surgery, the antiviral properties of silicon nitride implants probably have little consequence since viral infections of implanted biomaterials are not a practical problem. On the other hand, systemic viral infections and their spread through contaminated surfaces are a global concern. Drug treatments of established Influenza A infections, such as Tamiflu, are effective only in controlling symptoms by reducing viral load and the virus can still mutate to newly resistant, dangerous strains. The control of viral propagation by surface sanitization is therefore of worldwide interest; witness the hand sanitizers and other protections used commonly during the flu season. Surface sanitization destroys the virus itself, and commonly-used methods rely on ammonia, alcohol, silicon nanoparticles, and certain pH conditions to inactivate virus particles.”

“The latest findings show the above-surface conditions for viral disinfection are already manifest on Amedica’s silicon nitride whether the material is studied in bulk form or as a micron-layer coating on other surfaces. This property is a powerful advantage toward safe and reliable methods for viral inactivation and elimination. This fortuitous, intrinsic anti-viral effect of Amedica’s silicon nitride has broad applications in health care, from medical therapies to various medical devices and equipment such as examination tables, clothing, filters, masks, gloves, catheters, endoscopic instruments, and well beyond.”

“Previous data, supported by clinical studies, have established that Amedica’s silicon nitride enhances osteogenesis while resisting bacterial adhesion; both highly desirable properties in spinal fusion implants. Now, the material appears to be equally effective against the world’s most common pathogens, i.e., viruses that are responsible for a number of diseases and their global spread. Going forward, we will seek commercial applications and partnerships that can leverage the unique antiviral behavior of silicon nitride, a property that, to our knowledge, is not present in any other biomaterial known in the world today.”

Further to today’s announcement, Amedica will host a conference call on September 13, 2018 to discuss the agreement with CTL Medical and to provide a business update. Details related to this call will be provided at a later date.

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties, including without limitation the risks associated with generating data to support the patent application for the technology and of obtaining a patent that provides commercially significant protection for this technology; the risk that the technology may infringe the proprietary rights of third parties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts: Amedica IR 801-839-3502 IR@amedica.com

Mandatory joint pay model slashes spending in just eight months

Posted On September 7, 2018 By OrthoSpineNews In Regulatory /

By Virgil Dickson | September 6, 2018

A mandatory pay model aimed at reducing Medicare spending on joint replacement surgeries was able to save money in its first year. The CMS in recent years has scaled back and canceled mandatory models.

Under the Comprehensive Care for Joint Replacement program, average total payments decreased by 3.9% or $1,127 compared to hospitals not participating in the model, according to federal data released Wednesday. At the same time, researchers observed no statistically significant changes in the quality of care as measured by readmission rates, emergency department visits, and deaths.

The program gives hospitals a fixed payment for all services related to joint replacement surgeries from admission to 90 days after the procedure, with no additional payments for complications, readmissions or post-acute services.

“Possibly the most notable outcome during the first CJR model performance year was that statistically significant changes in utilization and payments occurred so quickly,” the report said.

The study analyzed results from 731 CJR participant hospitals and 841 hospitals not in the experiment, which lasted from April 1 to Dec. 31, 2016.

Last year, the CMS scaled back the CJR program citing the burden of the program and the belief that models should be largely voluntary. The CJR model is now only mandatory in 34 geographic areas compared to 67 geographic areas when it first launched.

The agency estimates that 465 hospitals are participating in the effort. That figure is down from 800 acute-care hospitals that were expected to participate in the program.

After interviewing hospital staff, researchers said there may not have been a change in the practice of medicine at these facilities had the experiment not been mandatory.

“These findings suggest that a mandatory model may impel action across a broad range of hospitals that may not otherwise have acted to reduce episode payments,” the report said.

Proponents of value-based care hope the results will encourage the CMS to reconsider the use of mandatory models. Many of the hospitals in CJR are ones that chose to skip other pay models such as the Bundled Payments for Care Improvement Initiative, according to Andrew Ryan, an associate professor in the department of health management and policy at the University of Michigan’s School of Public Health.

READ THE REST HERE

i-med-tower.ne-5-_wide-ec5e171ec1abb431e986cbd7544911d710f91877-s800-c85-12bto-1.jpg

Hospitals Prepare To Launch Their Own Drug Company To Fight High Prices And Shortages

Posted On September 7, 2018 By OrthoSpineNews In Regulatory /

September 6, 2018 / ALISON KODJAK

Sometimes IV bags are hard for hospitals to come by. Other times it’s injectable folic acid to treat anemias. Right now, the tissue-numbing agent lidocaine is in short supply.

Shortages of commonplace generic drugs have plagued hospitals in recent years. And with short supplies and fewer suppliers for key drugs, there have been price increases.

Hospital purchasing agents keep searching for new sources for the medications that patients need, while clinicians scramble to find alternatives.

“Every day at Intermountain we manage more than 100 drug shortages, and most of them are generics,” said Dr. Marc Harrison, president and CEO of Intermountain Healthcare, a system of 22 hospitals based in Salt Lake City. “The impact on patient care, in terms of trying to find alternatives and scurrying around and trying to find necessary drugs, is incredibly time-consuming and disconcerting.”

Now Intermountain, along with several other major hospital systems and philanthropies, is taking the problem in hand. They are launching a nonprofit, generic drug company to help fight rising costs and chronic shortages.

The company, called Civica Rx, will be independent. But the board will include so-called governing members that include Intermountain, the Mayo Clinic, and for-profit HCA Healthcare, among others. The companies are unveiling the new venture’s name, structure and leadership on Thursday. The intention to start it was announced in January.

The new company plans to market 14 common generic drugs that have been in short supply and whose prices have risen in recent years. Harrison declined to name the drugs.

“As we decided on the drugs we were really practical,” Harrison said in an interview. “We looked for drugs that were now in short supply. We looked for drugs that were on the lists of essential medications, and we looked for drugs that have had huge spikes in their prices.”

Drug shortages have become so widespread that Food and Drug Administration Commissioner Scott Gottlieb in July created a task force to come up with solutions. And last year the Justice Department, along with 45 states, accused a group of generic drug makers of price fixing.

READ THE REST HERE

Photo: Courtesy of Intermountain Healthcare

Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow

Posted On September 6, 2018 By OrthoSpineNews In Regulatory /

Deerfield, Ill. – September 6, 2018

Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (FDA) clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. As the newest addition to Baxter’s growing osteobiologics surgery portfolio, Actifuse Flow offers accelerated bone growth in a new, easy-to-use, prepackaged delivery syringe for precise placement into small bony voids or gaps in the skeletal system.

Actifuse Flow utilizes the proprietary silicate-substituted technology of Baxter’s Actifuse Bone Graft Substitute, which enhances silicon levels to accelerate bone formation[i]. Actifuse Flow comes ready to use with no mixing or preparation involved and maintains its flowable consistency throughout surgery. The bone graft substitute is delivered directly from a pre-loaded syringe with the ability to start and stop delivery, making it compatible with open and less invasive surgical techniques and well-suited for filling small bone defects and complex geometries. As the graft substitute resorbs, it is replaced by the patient’s own bone during the body’s healing process. Baxter expects Actifuse Flow to be used in a variety of orthopedic surgeries in the pelvis, extremities, and posterolateral spine.

“Baxter’s Actifuse Bone Graft Substitute has been demonstrated in preclinical models to show greater new normalized bone volumes over other available bone graft substitutes. As the graft resorbs into the body, it is replaced by natural bone during the healing process. Actifuse Flow offers that same reliability in an easy-to-use delivery device. I am pleased to count on the science behind Actifuse Flow to accelerate bone formation in my patients,” said Robert Norton, MD, an orthopedic spine surgeon serving patients in Boca Raton, Florida.

“As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse Bone Graft Substitute,” said Wil Boren, president of Baxter’s Advanced Surgery business. “We strive to pioneer products that provide surgeons innovative and dependable tools to help enhance healing, improve outcomes and reduce the total cost of care.”

Actifuse Flow is the latest addition to Baxter’s osteobiologics surgery portfolio, which also includes Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore. These products are based on a proprietary silicate-substituted technology designed to accelerate bone growth and come in varying configurations to accommodate different surgical needs. Baxter expects Actifuse Flow to be available to U.S. customers by year-end. It will be sold in three convenient sizes: 5 mL, 3 mL and 1.5 mL.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

Actifuse Flow Bone Graft Substitute Indication

Actifuse Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bone structure. Actifuse Flow is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Important Risk Information for Actifuse Flow Bone Graft Substitute

Actifuse Flow is contraindicated where the device is intended as structural/load-bearing support in the skeleton system. Actifuse Flow bone graft substitute has not been cleared for vertebroplasty.

Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.

The effect of mixing Actifuse Flow with substances other than sterile saline/water, autologous blood or bone marrow aspirate is unknown.

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.

This release includes forward-looking statements concerning Actifuse Flow, including potential benefits associated with its use [and anticipated launch dates]. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

Baxter, Actifuse Flow, Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore are registered trademarks of Baxter International Inc.

[i] Hing KA, et al. Comparative performance of three ceramic bone graft substitutes. Spine J. 2007; 7(4):475

tirbolox-l-tlif-plif-cage-3d-printed-implant-captiva-spine-pr-12bto.jpg

Captiva Spines’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Posted On September 5, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages.

TirboLOX-L Titanium Lumbar Cages

TirboLOX-L Titanium Lumbar Cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture. Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony ongrowth, ingrowth and vascularization. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging. TirboLOX-L’s high coefficient of friction creates immediate bidirectional fixation.

Dennis Ty, Director of R&D of Captiva Spine declared, “With the advanced capabilities of 3D Additive Manufacturing we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone ingrowth and vascularization. Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

Dale Mitchell, President and Founder of Captiva Spine said, “I am pleased our development team was able to incorporate our proprietary Pivotec® Pivoting TLIF Cage into TirboLOX. Pivotec technology has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”

Captiva Spine’s TirboLOX-L Lumbar Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

SEE MORE ABOUT TIRBOLOX-L

This Press Release can be found at PRWeb.com and is also featured on other media outlets.

0450802d51d6fce7215d1beb4b57a995_Sphynx_Antero_edenspine-414-311-c-2-12bto2-1.jpg

FDA Grants Eden Spine 510(K) Clearance for Its Thoraco Lumbar Spine Locking Plate – SPHYNX™

Posted On August 30, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

GENEVA, SWITZERLAND (PRWEB) AUGUST 30, 2018

The SPHYNX™ is the ideal complement to Eden Spine proprietary, expandable titanium vertebral body replacement implant with rotatable endplates, the GIZA™ which provides multiple angulation options by simple endplates rotation. The GIZA™ is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.

Made of titanium, the low profile SPHYNX™ is to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.

“The SPHYNX™ is the latest innovation coming from our R&D department in Geneva, Switzerland,” says Ben Mokhtar, President of Eden Spine Europe, SA. “Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal we have developed a cutting edge integrated locking system, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient’s anatomy.”
The SPHYNX™ was granted CE Mark approval in 2016.
——-
About Eden Spine Europe SA:
Eden Spine is a privately held, technology driven spinal organization based in Switzerland since 2005. The company distributes a range of innovative spinal technologies in the United States and abroad. Eden Spine patented portfolio is composed of a mix of fusion and non-fusion technologies.

For distribution opportunities, please contact us at
Customer.service(at)edenspine(dot)com or visit http://www.edenspine.com

Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons

Posted On August 28, 2018 By OrthoSpineNews In Regulatory /

August 28, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an added feature to the NovoStitch® Pro Meniscal Repair System – a size 0 suture cartridge – offering surgeons more options to repair meniscal tears.

The NovoStitch Pro system enables surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address meniscal tears which have not been amenable to repair in the past. With the addition of the NovoStitch Pro’s new 0 suture cartridge, surgeons have expanded options in suture size and are able to pass a complete stitch within the knee joint without having to remove the device to reload a suture, a common shortcoming among other systems.

More than 100,000 patients each year experience a common yet debilitating type of meniscal injury known as a meniscal root tear¹. The availability of the 0 suture cartridge to the NovoStitch Pro system offers greater flexibility to physicians performing meniscal root and other complex repairs.

“The considerable strain placed on the knee’s meniscus during common physical activities makes it particularly prone to injury,” said Dr. David Flanigan, professor of orthopaedics and director of the Cartilage Restoration Program at The Ohio State University Wexner Medical Center. “Having access to a larger suture provides additional possibilities for meniscal repair.”

“Ceterix continues to bring advanced technology to orthopaedic surgeons who are looking for better ways to preserve the meniscus,” said John McCutcheon, Ceterix’s president and CEO. “This latest innovation will be especially beneficial to those surgeons who prefer an ‘all-inside, all-suture’ procedure with a stronger suture for the more-demanding meniscal root repairs.”

The meniscus is a crescent of soft cartilage that sits between the femur and tibia, providing stability and shock absorption to the knee. The meniscus attaches to the tibia at its root but is subject to tearing at this attachment point. Historically, this type of repair would have been treated with a meniscectomy (complete or partial removal of the meniscus) which has been shown in studies to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life.²

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.^3,4

About Ceterix® Orthopaedics

Ceterix Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Pro Meniscal Repair System has received 510(k) clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures, and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter.

¹Cinque, M. E., Chahla, J., Moatshe, G., Faucett, S. C., Krych, A. J., & LaPrade, R. F. (2018, July 01). Meniscal root tears: A silent epidemic. http://dx.doi.org/10.1136/bjsports-2017-098942
²Chung et.al. Arth 2015 Oct; 31(10):1941-50.
³Brinker MR, O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.
⁴New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006.

Contacts

for Ceterix Orthopaedics, Inc.
Durae Hardy
Durae@healthandcommerce.com