Paragon 28® Increases Its Robust Ankle Fracture Offering – Gorilla® Ankle Fracture Plating System – Posterior Plating System Launched

Posted On September 26, 2017 By OrthoSpineNews In Extremities, Top Stories /

ENGLEWOOD, Colo., Sept. 26, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results that benefit both the surgeon and patient.

The addition of Posterior Plates to the Gorilla® Ankle Fracture Plating System further expands Paragon 28’s robust foot and ankle specific portfolio. The Gorilla® Ankle Fracture Plating System now offers surgeons 44 total plates in seven families to address distal fractures of the fibula and tibia. The Posterior Plates are offered across four families and provide surgeons 20 unique options to address fractures of the tibia and fibula from a posterior approach.

Paragon 28 Gorilla® Ankle Plating System – Posterior Plates

Posterolateral Fibula Plate

Narrower in design than the anatomic and straight fibular plates to allow for better fit when placed on the posterior and posterolateral surfaces of the fibula
Distal screw configuration is oriented to avoid anatomic structures when used with a lateral or posterior incision
Can also be used as an anti-glide plate in order to buttress the distal fragment from shifting proximally

Posterolateral Tibia Plate

Contoured to match the anatomy of the posterior tibia
The two most distal screw holes are angled superiorly to avoid the concave surface of the tibia
Lateral plate placement helps avoid Flexor Hallucis Longus (FHL) tendon

Posteromedial Tibia Plate

Designed for a posterior pilon variant fracture
Contoured to match the anatomy of the posterior tibia

Trimalleolar Fracture Plate

Designed for the posterior malleolar fracture of a trimalleolar fracture
Plate has a slight concavity to minimize the need for interoperative bending to match the posterior tibia
Plate is designed to prevent superior translation of the fracture fragment, as an anti-glide concept

Paragon 28 is grateful for the significant contributions Dr. Christopher Zingas, MD, Dr. John Kwon, MD and Dr. Michael Houghton, MD made as the surgeon designers of this system.

Product Page:
http://www.paragon28.com/products/ankle-fracture-plating-system/

CONTACT: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

SOURCE Paragon 28

Medicrea Partners with Orthopaedic Surgeon in World’s First 360-Degree Personalized Spine Surgery

Posted On September 26, 2017 By OrthoSpineNews In Spine, Top Stories /

September 26, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD ASI™ technology, announced today the successful completion of a 360-degree spinal surgery using a bespoke combination of patient-specific implants generated by Medicrea’s proprietary UNiD ASI™ system technology.

The complex two-stage operation took place in London at the Wellington Hospital and was performed by Orthopaedic Surgeon, Dr. Benjamin Taylor, MB, BS, MCh(ortho), FRCS, FRCS(Ed). Dr. Taylor partnered with Medicrea’s UNiD LAB™ team of specialized biomedical engineers to strategically plan the operation and design four custom implants to be precisely manufactured in titanium at the company’s new ultra-modern facilities, all within a tight deadline before surgery. The successful outcome was the result of patient-specific spinal instrumentation being implanted from the front and back to create the first-ever 360-degree personalized spinal surgery.

“The ability to strategically plan and manufacture personalized implants in a controlled iterative process generated by Medicrea’s proprietary UNiD ASI™ system technology was a key element in the success of this operation, helping me to simplify and expedite the procedure. Because the implants are scientifically designed using clinical data, I am confident that this patient will continue to see improvements in their quality of life due to the sophisticated outcome-based technology that UNiD ASI™ injects throughout the process,” stated Dr. Taylor following the operation.

Medicrea’s UNiD ASI™ systems technology was used to create a fully personalized solution for the operation that was adapted to both surgeon and patient requirements. The process began with the Company’s UNiD LAB™ engineers using proprietary planning software to turn Dr. Taylor’s surgical plan into a fully digital simulation using patient imaging. The optimal surgical strategy was then identified by Dr. Taylor who was able to draw on the technology’s Adaptive Spine Intelligence™ to directly answer to his and his patient’s needs. Medicrea’s engineering team took this strategy and translated the digital plans into patient-specific implants, using its proprietary manufacturing techniques to create bespoke spinal rods and interbody devices for the operation.

On the day of the surgery, the implants were already at the hospital, prepared to be placed in two stages. First, Dr. Taylor addressed the patient’s spine through an anterior approach where three custom UNiD™ Cages were inserted between the patient’s lumbar vertebrae to restore the exact height to the spine according to the patient’s unique anatomy. The implants were also perfectly sized to form an exact fit between the patient’s vertebrae, leading to a marked reduction in the operation time required to size and place standard off-the-shelf implants.

In the second stage of the operation, the patient’s spine was approached posteriorly. Here, Dr. Taylor inserted two patient-specific UNiD™ Rods to stabilize the patient’s spine in a predetermined patient-specific alignment. Sagittal alignment of the spine is well known to be directly correlated with the long-term success of a spinal surgery, and as such, matching the rod’s shape with the patient’s unique spinal curvature is a critical component of the surgery and was previously only achieved by manually bending the rod during the operation.

Denys Sournac, President and CEO of Medicrea, stated, “Our partnership with Dr. Taylor in this case demonstrates the power of UNiD ASI™’s system-based approach. We offer true collaboration with surgeons to deliver outcome-based data science that is adapted to surgeon and patient in each spine surgery. The result has been to drive improved outcomes and efficiencies in more than 1,500 UNiD ASI™ cases to date. ”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

Stryker’s Serrato Pedicle Screws Implanted by More Than 100 Surgeons in First Month, Prior to Full Commercialization

Posted On September 26, 2017 By OrthoSpineNews In Spine, Top Stories /

September 26, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that Serrato™ Pedicle Screws have been implanted by more than 100 surgeons across the U.S. during the first 30 days since release, prior to full commercialization.

The Serrato Pedicle Screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque, and True-tip geometry, which allows for precise insertion and immediate bone engagement. Stryker’s design innovations elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgeon efficiency.

“We are very excited by the initial response to Serrato from our early users,” said Bradley Paddock, President of Stryker’s Spine division. “The feedback from surgeons is exceeding expectations.”

“Game-changing screw,” said Roderick Sanden, M.D., an orthopedic surgeon with Advanced Neurospinal Care and Sutter Roseville Medical Center in Northern California. “I never thought a pedicle screw made that much of a difference until I put in a Serrato screw.”

“The Serrato screw insertion was exactly what I was hoping for,” said Scott Luhmann, M.D., Head of Surgery, Pediatric Orthopaedics at Shriners Hospital for Children in St. Louis. “It allowed for easy initiation of the screw, good tactile feedback, and excellent purchase!”

The Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia^® 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May 2017. Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purpose of stabilization. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Content ID: TLSER-PR-2_15523

Dr. Luhmann is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Contacts

Sullivan & Associates
Barbara Sullivan, 714-374–6174
bsullivan@sullivanpr.com

JointPoint, Inc. Signs Exclusive Agreement with DePuy Synthes to Co-Market JointPoint’s Non-Invasive Computer Navigation System for Hip Replacement

Posted On September 25, 2017 By OrthoSpineNews In Recon, Top Stories /

BELLEAIR BLUFFS, Fla., Sept. 25, 2017 /PRNewswire/ — JointPoint, Inc., providers of non-invasive computer navigation, preoperative digital templating, case planning, and intra-operative feedback, is announcing that it has signed an exclusive agreement with DePuy Synthes to co-market its proprietary software platform. JointPoint™ integrates easily into the Direct Anterior Approach hip replacement technique.

“With over 1,000 cases completed over the last several months, surgeons are enjoying the benefits of JointPoint’s non-invasive hip navigation,” said Noah Wollowick, President and Co-Founder of JointPoint. “We are excited to solidify this co-marketing agreement with DePuy Synthes, a worldwide leader in orthopaedics, to gain better access to surgeons across the country that want to use our innovative technology.”

JointPoint’s intraoperative software streamlines fluoroscopic use while providing the surgeon significant data on cup position, leg length and offset. Additionally, JointPoint’s OneTrial™ technology incorporates implant specific data that has the potential to reduce trialing during surgery.

“I used to rely on multiple fluoroscopic images and trials to confirm a patient’s leg length and offset,” said Dr. Charles Decook, MD. “With the OneTrial™ technique from JointPoint, I am able to trial and shoot one fluoroscopic image, that is it. It tells me my offset and leg length and I am able to clearly pick the neck and head that works best for that patient. It has not only made me more efficient but also more accurate. I wouldn’t even think of interpreting a fluoroscopic image now without JointPoint.”

Adding the JointPoint software to a surgeon’s protocol may help reduce leg length discrepancy and complications related to inaccurate cup placement and final implant selection – two of the most important considerations in hip replacement surgery – by providing pre-surgical digital templating and real-time, data-driven surgical decision making in the operating room.

JointPoint’s navigation system minimizes adoption challenges of the anterior approach surgical method for hip replacement by providing cup position, leg length and offset data for a surgeon using as few as 3 radiographic images.

“One of the major benefits of anterior approach hip replacement is the power of intraoperative fluoroscopy and its ability to improve implant positioning, something all surgeons strive for consistently,” said Andrew J. Cooper, M.D., JointPoint’s Chief Medical Officer and Co-Founder. “JointPoint harnesses the potential of fluoroscopy and allows surgeon to meet this goal efficiently with minimal images.”

About JointPoint, Inc.

JointPoint, Inc. develops and markets software-driven medical technology for orthopaedics. The JointPoint™ software solution and OneTrial™ technology is a completely non-invasive navigation system for hip replacement surgery that provides intraoperative data and guides component selection while also optimizing efficiency within a surgical workflow. For more information, visit http://www.jointpoint.com

SOURCE JointPoint, Inc.

Warding Off Decline, Hospitals Invest in Outpatient Clinics

Posted On September 25, 2017 By OrthoSpineNews In Financial, Top Stories /

By Melanie Evans/September 25, 2017

Some of the hospital industry’s most active investing these days is happening outside the hospital.

Giant U.S. hospital operators, including Tenet Healthcare Corp., Dignity Health and HCA Healthcare Inc., are investing heavily in surgery centers, emergency rooms and urgent care clinics located outside hospitals, chasing after patients who increasingly want cheaper and more convenient care.

Insurers and employers that pay for health care are helping drive the change as they shift more Americans to high-deductible insurance plans, which require patients to pay more of their medical bills before insurance kicks in. That has pushed more patients to seek lower-cost options, says RBC Capital Markets managing director Frank Morgan, a hospital analyst.

Hospital demand slumped during the last recession, a trend that has continued even as the economy recovers, American Hospital Association data through 2014 show. Admissions growth at HCA hospitals has slowed in recent quarters to 1% to 2%, as a boost from the Affordable Care Act faded, while Tenet’s admissions have been flat or down 1% to 3% most quarters since late 2015.

In an effort to strengthen their hold on their markets and prevent rivals from siphoning off patients, hospitals are investing outside their own walls. They are “following the patient,” Mr. Morgan said.

The strategy also places hospital satellites closer to where patients live and work, which executives say they hope will win over new, loyal customers.

In July, Ashley Hammack rushed to a new free-standing ER in Spring Hill, Tenn., after growing weak from vomiting. The facility, a satellite of TriStar Centennial Medical Center, is a 10 minute drive from her home, about 20 minutes closer than the hospital where she delivered her daughter five months before.

Doctors saw her quickly. “I never even sat down,” Ms. Hammack recalled. She was treated for severe dehydration from what doctors suspected was food poisoning and sent home with medication.

Trevor Fetter, Tenet’s outgoing chief executive, says company executives have pursued rapid outpatient expansion partially out of necessity. Slumping admissions contributed to Tenet and HCA lowering their earnings estimates for 2017, which in turn hit stock prices.

It’s unclear how the shift to out-of-hospital care will affect long-term earnings. Non-hospital operations typically generate lower revenue than hospitals but produce higher profit and require less capital to build and run.

But “it’s happening anyway,” Mr. Fetter said. “Somebody else is going to do it to us if we don’t do it ourselves.”

READ THE REST HERE

Bone Therapeutics SA and Asahi Kasei sign exclusive license agreement for PREOB® in Japan

Posted On September 22, 2017 By OrthoSpineNews In Biologics, Top Stories /

Gosselies, Belgium, 22 September 2017, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation (Tokyo: 3407). The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB^®, in Japan.

Under the terms of the agreement, Asahi Kasei will obtain exclusive rights to develop, register and commercialise PREOB^® for the treatment of osteonecrosis of the hip with the potential for other orthopaedic and bone applications in Japan. Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of stem cells into bone-forming cells in preparation for continued clinical development by Asahi Kasei in Japan. In addition, Bone Therapeutics has also granted Asahi Kasei an option to negotiate an exclusive license for the development and commercialization of PREOB^® in Korea, China and Taiwan.

Bone Therapeutics will receive an upfront payment of €1.7 million from Asahi Kasei and is eligible to receive up to €7.5 million from development and commercial milestone payments, as well as tiered royalties based on annual net sales of PREOB^® in Japan.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “This agreement is an important additional validator of our innovative regenerative technology in the field of orthopaedics and bone diseases and of its global, commercial potential. With its world-class research and development capabilities, its strong network and specific knowledge of the Japanese market, we believe Asahi Kasei is the ideal partner to develop and commercialize PREOB^® in Japan and bring this promising therapy to patients in Asia. We look forward to working with the team at Asahi Kasei as we bring our platform closer towards commercialisation.“

Hideki Kobori, President & Representative Director of Asahi Kasei Corporation, said: “We are delighted to be collaborating with Bone Therapeutics to develop and commercialize its unique autologous cell therapy product, PREOB^®, in Japan. The field of orthopaedics is a major area of focus for Asahi Kasei and we believe PREOB^® has the potential to add significant value to our current pipeline and has the potential to be a first-in-class treatment for patients suffering from debilitating bone conditions, such as osteonecrosis of the hip.“

About PREOB^®:

PREOB^® is Bone Therapeutics’ cell-based medicinal product derived from autologous (derived from the patient) bone marrow mesenchymal stem cells. The active part of the product comprises human autologous osteoblastic cells, which are specialized cells that have the ability to restore a healthy bone environment and promote bone regeneration. Local implantation of these biologically active osteoblasts at the bone defect site is intended to mimic the natural process of bone formation and repair.

Today, PREOB^® is being developed as a first in-line conservative treatment for early stages of osteonecrosis of the hip. Based on the promising results from an earlier Phase IIB study, which have shown clinically and radiologically relevant benefits, PREOB^® is currently being evaluated in a pivotal Phase III study in Europe in the treatment of this debilitating disease. Key interim efficacy results are expected in Q3 2018 and could lead to a premature termination of patient recruitment.

About Asahi Kasei Corporation:

Asahi Kasei, headquartered in Tokyo, Japan, is one of Japan’s leading industrial companies, with a combined revenue of €15 billion and more than 33,000 employees, and a global leader in a diverse range of markets, including pharmaceuticals, medical devices and bioprocess consumables. Through its pharmaceutical core operating company, Asahi Kasei Pharma, the group is growing as a specialty pharmaceutical firm with a global presence by focusing on the development of new world-class drugs in the fields of orthopaedics, circulatory, urology, the immune system, and the central nervous system. For more information, please visit the company’s website at www.asahi-kasei.co.jp/asahi/en/.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB^®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB^®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Integra LifeSciences Announces First Patient Enrolled in Cadence® Total Ankle System Post-Market Study

Posted On September 21, 2017 By OrthoSpineNews In Extremities, Top Stories /

PLAINSBORO, N.J., Sept. 21, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced the first Cadence^® Total Ankle System has been implanted by Dr. David Pedowitz with the Rothman Institute in Philadelphia, Pennsylvania in the Cadence Total Ankle System non-randomized, prospective, multi-center post-market study.

“While this patient represents only one of many who have already benefited from the Cadence Total Ankle System, she is the first of my patients who will be a part of this important study, documenting the unique benefits of this new system in terms of ease of use, patient satisfaction, and survivability,” said Dr. David Pedowitz.

The primary objective of the study is to evaluate 2-year implant survivorship in subjects who received the Cadence Total Ankle System for primary ankle arthroplasty. Implant survivorship will further be evaluated at 5 and 10 years post-operatively. All patients in the study will receive the Cadence Total Ankle System.

About Cadence
Cadence Total Ankle System, is a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto, Toronto, Canada), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pennsylvania), Dr. Selene Parekh (Duke University, Durham, North Carolina) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio). To date, more than 350 Cadence total ankle procedures have been successfully performed in seven countries.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique. Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedures. Key implant features include:

Side-specific, anatomical tibial components, designed to avoid fibular impingement.
Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Integra LifeSciences Holdings Corporation

Investor Relations Contact:

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media Contact:

Laurene Isip
609-750-7984
Laurene.isip@integralife.com

Spine Surgeon in Thailand Successfully Completes First International Mazor Robotics PROlat™ Case

Posted On September 20, 2017 By OrthoSpineNews In Robotics, Spine, Top Stories /

ORLANDO, Fla. – September 18, 2017 – Mazor Robotics, a pioneer and leader in the field of surgical guidance systems, announced that the first international PROlat case was performed by Assoc. Prof. Wicharn Yingsakmongkol, MD in Bangkok, Thailand. PROlat is a single-position solution for placing pedicle screws and other spinal hardware in the lateral decubitus position with the Renaissance® Guidance System.

“Lateral approaches have been gaining acceptance in Asia, as we have an aging population that benefits highly from minimally invasive procedures,” said Prof. Yingsakmongkol. “I perform a high volume of lateral procedures each year, so the PROlat application was something that made a lot of sense to me as a way to enjoy the benefits of the Renaissance technology while the patient remains in a single lateral position. We were able to save 30-40 minutes by not flipping the patient, which is less time for the patient to be under anesthesia, and less cost for the hospital.”

Mazor also recently fulfilled orders for the PROlat application in Spain and Australia and continues to see a lot of interest for this procedural solution in the international markets.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Mazor Robotics Announces CE Mark Approval for the Mazor X Surgical Assurance Platform

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Robotics, Top Stories /

September 20, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, announced today CE Mark approval for its Mazor X Surgical Assurance Platform. The CE Mark allows Mazor and its commercial partner, Medtronic, to market the Mazor X in the European Union, as well as other countries that recognize the CE Mark.

“Receipt of the CE Mark is an important step in our plan to expand the patient, surgeon and hospital benefits of the Mazor X Surgical Assurance Platform to the European market,” said Ori Hadomi, Mazor’s Chief Executive Officer. “Our commercial partner for the Mazor X, Medtronic, will be responsible for marketing and selling the system in Europe and we look forward to working with them to ensure a successful launch.”

The Mazor X will be displayed in Medtronic’s booth (F10) at EUROSPINE, which is being held from October 11-13, 2017 in Dublin, Ireland.

About Mazor

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of CE Mark approval, statements regarding the marketing and selling of the system in Europe, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Stryker’s Spine Division Receives FDA Clearance for 3D-Printed Tritanium® C Anterior Cervical Cage

Posted On September 20, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

September 20, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium^® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has received 510(k) clearance from the U.S. Food and Drug Administration.

The Tritanium C Anterior Cervical Cage is constructed from Stryker’s proprietary Tritanium In-Growth Technology,¹ a novel, highly porous titanium material designed for bone in-growth and biological fixation.¹ Tritanium material may be able to wick or retain fluid, in contrast to traditional titanium material.²

“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage,” said Bradley Paddock, President of Stryker’s Spine division. “The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility, and quality our customers have come to expect.”

The unique porous structure of the Tritanium material is designed to create a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study.³* It is inspired by the microstructure of cancellous bone⁴ and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

The Tritanium C Anterior Cervical Cage features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,⁵ the cage has serrations on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies. It will be available to surgeons in Q4 2017.

Intended Use (US)

The Tritanium C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. The cage is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. For the full indications for use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

References

PROJ43909: Tritanium technology claim support memo
RD0000050927: Tritanium material capillary evaluation
RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
PROJ44960: Coefficient of friction memo

Content ID TRICC-PR-1_15507

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com