Prosidyan Announces FDA Clearance and Commercial Launch of Its FIBERGRAFT BG MATRIX for Poster-Lateral Spinal Fusion

Warren, NJ, October 26, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today FDA 510(k) clearance and full commercial launch of FIBERGRAFT BG Matrix – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Matrix is the third generation product in the company’s FIBERGRAFT line of bioactive glass fiber based products. FIBERGRAFT BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.

FIBERGRAFT BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseaous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.

Here are some comments from the early users of FIBERGRAFT BG Matrix:
Dr. Paul Slosar MD of the San Francisco Spine Institute commented, “I have an interest in the growing scientific research focused on bone graft extenders and am impressed by the FiberGraft’s basic science data. I recently had the opportunity to use the Fibergraft Matrix in several cases where I needed to augment my posterior fusion, when we didn’t have enough autograft. The Fibergraft had excellent handling characteristics and interdigitated very nicely with the host bone. The Fibergraft provided me with an excellent option to reinforce my bone graft and, based on their scientific data, I anticipate excellent clinical fusion results.”

Dr. Adam Bruggeman MD of the Texas Spine Care Center commented, “Fibergraft Matrix from Prosidyan is an innovative update to their leading fiber based bioglass portfolio. Matrix is easy to manipulate, allowing for multiple applications. It is now my preferred graft for all biologic applications in the spine.”

Dr. Todd Allen, MD, PhD Associate Professor Orthopaedic Surgery UCSD commented, “The structural and handling features are dynamic and second to none with an innate ability to wrap around bony structures and wick needed blood and cells to the region. The structural and biologic capabilities of this unique synthetic are powerful, and make this a great product for the future of spine surgery, both in open and MIS applications.”

Prosidyan’s Founder & CEO Charanpreet Bagga informed that FIBERGRAFT BG Matrix was presented at the 2017 North American Spine Society Innovative Technology Presentations on October 25th by Dr. William Walsh PhD, of UNSW. There were only seven technologies selected for presentation at this forum and FIBERGRAFT is the only synthetic bone graft substitute selected for this prestigious forum.

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 9,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.

Contact Information
Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com

Mizuho OSI® Introduces New Levó Head Positioning System for Spine Procedures

UNION CITY, Calif.Oct. 25, 2017 /PRNewswire/ — Mizuho OSI®, a leading manufacturer of specialty surgical tables, pressure management solutions, and table specific patient care kits, is introducing its newest technology, the Levó Head Positioning System at NASS 2017. Using an innovative electro-mechanical technology to enable the device’s motion, the Levó System introduces a new level of actuated control and precision to head positioning for all spine procedures from cervical to sacrum. The Company is unveiling the technology in booth #717 for physicians to experience the elevated positioning capabilities afforded by Levó.

Positioning patients for spine surgery is essential for optimal operating conditions and operative site exposure. The Levó System is designed to provide the surgical team with an interface that is safe, fast, and easy to engage. The technology’s unique interface places the surgeon in control, supporting initial head positioning and cervical spine corrections throughout the procedure. Various interchangeable modules that support the use of a skull clamp or face pillow comprise a versatile platform that delivers optimal utilization within each practice.

Designed to provide fluid, yet controlled motion, Levó’s functionality supports an improved workflow and enhanced surgical access. This is achieved through key modules, including the QuickConnect System, which supports the efficient attachment of a skull clamp, and the Control Handles, which allow for intraoperative adjustments.

“In designing the Levó System, we wanted to offer surgeons a seamless and flexible solution that affords them better control over patient positioning during these delicate procedures,” said Greg Neukirch, vice president of Marketing and Sales at Mizuho OSI. “We’re proud to unveil a solution we believe works to enhance clinicians’ surgical experience, providing for safe and precise care when positioning a patient’s head for all prone spine procedures.”

Mizuho OSI is offering hands-on demonstrations of the Levó Head Positioning System at NASS 2017 in Orlando, Fla. from October 25-27 in Booth #717.

About Mizuho OSI

Mizuho OSI® is a U.S. based company and the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improves patient outcomes in spine and orthopedic surgeries, a range of general surgical tables, and consumable surgical patient care products. Mizuho OSI products are sold direct in the U.S. and Germany, and by the Mizuho Corporation in Japan. Both companies sell their products and solutions worldwide through authorized international distributors. Mizuho OSI is a wholly owned subsidiary of Mizuho Corporation located in Tokyo, Japan, a leading surgical table manufacturer in Asia. The Mizuho Group also includes Trilux Medical®, a subsidiary of Mizuho OSI. Trilux Medical is a provider and manufacturer of surgical lights, surgical pendants, operating room patient integration, video management systems, and turn-key operating room solutions. Trilux Medical products and solutions are sold direct in Germany and worldwide through authorized international distributors. More information is available at www.mizuhosi.com

 

SOURCE Mizuho OSI

Related Links

http://www.mizuhosi.com

RTI Surgical® Schedules 2017 Third Quarter Earnings Call for November 2, 2017

October 26, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the third quarter 2017 on Thursday, November 2, 2017 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss third quarter results at 8:30 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical Inc.
Jonathon Singer
Chief Financial and Administrative Officer
jsinger@rtix.com
or
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

Cerapedics Announces i-FACTOR™ Peptide Enhanced Bone Graft Adopted by More than 150 Leading U.S. Hospitals

WESTMINSTER, Colo.Oct. 26, 2017 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that more than 150 leading U.S. hospitals have now adopted use of i-FACTOR™ Peptide Enhanced Bone Graft. Cerapedics received Premarket Approval (PMA) for i-FACTOR bone graft from the U.S. Food and Drug Administration (FDA) in late 2015 for use in ACDF procedures in patients with degenerative cervical disc disease. The company had initiated U.S. commercial activities in June 2016 following FDA approval of final IFU labeling and additional product sizes.

“The available options including bone morphogenetic protein therapies present both safety risks and significant costs,” said Dan Peterson, MD, FAANS & FACS, neurosurgeon at Austin Brain and Spine. “Increasingly surgeons and hospitals are recognizing the advantages of the i-FACTOR Bone Graft’s synthetic small peptide (P-15) technology in helping to improve safety and outcomes.”

i‐FACTOR Bone Graft is based on proprietary P-15 technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. It is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine backed by Level 1 human clinical data.

“We are continually hearing about development of new options to support bone regrowth and repair, including use of stem cell technologies,” said Neill Wright, MD, FAANS, Herbert Lourie Professor of Neurological Surgery at Washington University School of Medicine. “In many cases, available data do not confirm that both performance and costs are in line to deliver optimal outcomes for patients and hospitals. With i-FACTOR Bone Graft we have that data and can feel confident about both performance and cost advantages.”

In September 2017, Cerapedics announced publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR Bone Graft. The results published in the peer reviewed journal Neurosurgeryshow i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft.

“Our national commercialization and sales strategy is well positioned to meet the rapidly expanding interest in i-FACTOR Bone Graft,” said Glen Kashuba, CEO of Cerapedics. “We fully expect the rate of adoption to continue to grow rapidly in 2018 with over 100 additional hospital approvals pending as more surgeons and hospitals recognize the clear advantages of our technology over currently available options.”

About Cerapedics
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

 

EOI Announces Initial Surgeries With the FLXfit™15, the First Articulated and Expandable Cage With 15 Degrees of Lordosis Correction

OR AKIVA, IsraelOct. 26, 2017 /PRNewswire/ –Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced first surgeries with its enhanced 3D expandable cage, the FLXfit™15.  The FLXfit™15 offers enhanced performance and versatility by providing additional device sizes with the ability to further expand the device up to 4mm to achieve controlled expansion and lordosis correction of up to 15⁰.

Dr. Marc Weinstein, at the Spine Center at the Florida Orthopaedic Institute in Tampa, FL commented, “EOI’s attention to surgeons’ feedback and ability to innovate quickly is imperative in this environment”. He said, “This new higher range expansion will enable us to better treat our patients and restore segmental lordosis up to 15 degrees. This will have a tremendous impact on our ability to improve the patient’s sagittal balance and long-term surgical outcomes.” Dr. Weinstein concluded ,”This is an ideal implant for my L5/S1 fusion patients given the reduced size on entry and the need for enhanced lordosis at this level.”

Dr. Hamad Farhat, of Chicago, Illinois said, “The new 32mm length option adds great flexibility in treating patients with smaller anatomies as well as higher vertebral levels. The smaller size will allow 15 degrees of lordosis correction with additional space to pack more bone graft material”. He explained, “Expandable cages play a key role in successful MIS fusion procedures. The ability to deliver an ALIF type footprint cage with upto 15 degrees of lordosis correction through a minimal, unilateral approach is definitively a paradigm change in the MIS fusion market.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented, “We are excited with the first surgeries with the FLXfit™15. This represents our continued commitment for innovation and collaboration with our surgeons to deliver state of the art spine fusion technology designed to improve long term patients’ outcome.”  He said ,”We believe that the performance and versatility of the new FLXfit™ family will catapult EOI to gain greater share in fusion surgery both in MIS and open approaches.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:

David Elkaim
VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347) 3219683

 

SOURCE Expanding Orthopedics Inc.

4WEB Medical Demonstrates Increased Subsidence Resistance for Lateral Spine Truss System Compared to Annular Implants

ORLANDO, Fla.Oct. 26, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced the results of a new study demonstrating reduced subsidence for its Lateral Spine Truss System (LSTS) as compared to annular interbody implant designs today at the annual meeting of the North American Spine Society.  The study was led by Vijay Goel, PhD at the University of Toledo, one of the country’s foremost orthopedic biomechanics institutes.

“Our biomechanical testing showed the 4WEB 18mm wide, 40mm long LSTS implant performed better in resisting subsidence than the competitive 21mm wide, 60mm long annular design lateral device.  This finding was consistent across all density foam blocks tested.   These results are indicative of the optimized load distribution that is inherent to the 4WEB truss implant technology,” said Vijay Goel, PhD at the University of Toledo.

4WEB’s proprietary open architecture truss design increases endplate to implant contact maximizing resistance to subsidence.  The additive manufacturing process for truss technology provides a hierarchal surface roughness spanning from the nano to macro scale which may contribute to stimulating an osteogenic response.

Tony Tannoury, MD, Director of Spine at Boston Medical Center, Boston University said, “Subsidence is a clinically documented occurrence in lateral fusion procedures with higher incidences being found among smaller footprint implants.  This research allows me to confidently conduct minimally invasive lateral access surgery and match the correct size implant to the patient anatomy with less concern of the cage subsiding.  The results of this study are particularly important for high risk patients with low bone density.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

Atlas Spine Inc., Announces the Hiring of Matthew Miller as Executive Vice President of Business Development

Jupiter, FL — (PR Newswire) — Atlas Spine, Inc., a high technology spine implant company focused on the development of innovative, disruptive implants and instrumentation for spine surgery, has hired Matthew Miller as Executive Vice President of Business Development.

Miller has over 25 years in orthopedics and spine experience and has co-founded or been instrumental in the development of several high-profile orthopedic and spine companies.

In 2005 he raised over $14 million in seed capital for SpineMedica, Inc., which licensed technology a hydrogel material from The Georgia Institute of Technology and Salumedica, Inc. as an artificial disc.  In 2007 Miller co-founded MiMedx Group, Inc. with licensed technology from the University of South Florida and the Shriners Hospital for Children. Miller and his team took the company public when Pete Petit stepped in to run the public company. Most recently he was a co-founder of The Genomics Cancer Institute, a company focused on the commercialization of genomic and esoteric cancer testing in partnership with NCI-accredited hospitals.

“I’m elated and grateful for the opportunity to be part of the team at Atlas Spine, Inc. Atlas is committed to developing innovative and disruptive spine implants and surgical technology. More importantly, the talent the company has assembled is inspiring. Every team member is committed to developing the best products that serve the needs of spine surgeons and benefit patient outcomes. I couldn’t be more pleased to jump back into the spine industry than I am with Atlas Spine, Inc.”

As Executive Vice President of Business Development, “I’ll be finalizing a mezzanine financing round and working with the executive team to deploy capital to support the launch of several products we have in front of the U.S. Food and Drug Administration. I can’t talk about the products prior to their approval, which for those who know me, is very difficult. We have some game-changing products coming to market. I can’t wait.”

Atlas Spine, Inc., is a privately held spine implant company based in Jupiter, Florida. Atlas is committed to the development of innovative spine implants that benefit surgeons and provide better patient outcomes. 

Media:  Please contact Matt Miller, at 813-368-6011 or mmiller@atlasspine.com for information about the company. Interviews and photos are available upon request.

 

Matt Miller

EVP Business Development

 

Atlas Spine, Inc.

1555 Jupiter Park Dr.

Jupiter, FL 33458

Office:  561-741-1108

Cell:  813-368-6011

www.atlasspine.com

Medicrea Unveils New U.S. Business Development Model with Hiring of Joseph Walland as Executive Vice President of Sales and Richard Washburn as Executive Vice President UNiD™ ASI

October 25, 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™ Adaptive Spine Intelligence (“ASI”) technology, announced today that the Company has hired Joseph Walland as Executive Vice President of U.S. Sales, and Richard Washburn as Executive Vice President UNiD™ ASI, to support its new business development model in the United States, effective October 23, 2017.

Denys Sournac, President and CEO of Medicrea, stated, “I am pleased to welcome Joseph Walland and Richard Washburn to Medicrea. The addition of these profoundly experienced industry executives strengthens our global leadership position and accelerates our ability to execute on the Company’s strategic growth and business development model via Medicrea’s proprietary and disruptive UNiD™ ASI technology.”

Joseph Walland joins Medicrea as Executive Vice President of U.S. Sales with more than 15 years’ commercial experience in spine, most recently as the Western Area Vice President for Stryker Spine, responsible for more than $120 million in annual revenue. Mr. Walland will lead the Company’s transformation of its U.S. sales organization and accelerate the utilization of UNiD™ ASI services throughout the entire U.S. Enterprise.

Richard Washburn joins Medicrea as Executive Vice President and will head the newly-formed UNiD™ ASI division with more than 20 years of experience in new product development, operations and medical device commercialization. With a background in engineering, Mr. Washburn has held prominent leadership positions in the industry, including Director of Marketing at Globus Medical, President of Core Essence Orthopaedics, Inc., and most recently Chief Technology Officer at Trice Medical. Mr. Washburn will take a key leadership role in Medicrea’s organization charged with shaping the ground-breaking integrated service solutions of the disruptive UNiD™ ASI platform.

Mr. Washburn will work hand-in-hand with the Company’s Chief Scientific Officer, Thomas Mosnier, PhD, to align the strategic and clinical research efforts of the Company’s UNiD™ ASI technology platform, including UNiD™ LAB engineers and consultants, UNiD™ HUB intelligent surgical planning software and UNiD™ TEK patient-specific implants.

In conjunction with the appointments of Joseph Walland and Richard Washburn, Medicrea is accelerating the implementation of a new business development model in the United States. Focused around the execution of strategic commercial and innovation goals for the Company, Medicrea is poised to transform its commercial efforts in the United States to fully synchronize with the Company’s ongoing integration of its proprietary UNiD™ ASI digital healthcare platform.

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 150,000 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
LEI: 969500BR1CPTYMTJBA37

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

New DePuy Synthes Spine Technologies Help Simplify MIS by Enhancing Efficiency and Reducing Steps

ORLANDO, Fla.Oct. 25, 2017 /PRNewswire/ — DePuy Synthes* today is launching two solutions for minimally invasive spinal fusion surgery (MIS) designed to simplify the procedure, particularly as MIS gains traction and shows reduced complications compared to open surgery in treating degenerative disc disease in the back.1,2

Research shows the number of MIS fusion surgeries conducted in 2010 accounted for one-sixth of the total number of all spine surgeries in the United States and is expected to be more than half of all spine surgeries in 2020.3 As MIS becomes more common, there is a significant need to simplify these procedures, especially the complexity associated with degenerated disc removal and pedicle screw insertion.

The VIPER PRIME™ System combines multiple instruments into one pedicle screw inserter tool that reduces the number of instrument passes. The single-use CONCORDE® Clear MIS Discectomy Tool allows surgeons to complete the degenerated disc-clearing process faster on average and more efficiently compared to traditional discectomy tools while increasing the amount of disc material removed.4 These products are being showcased here at the North American Spine Society meeting.

“As a global leader in spine, we have a responsibility to continue to innovate to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “Both the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool are examples of how we are providing differentiated technologies that simplify spine surgery and make it more reproducible for every surgeon while reducing the impact on patients.”

VIPER PRIME System Inserts Pedicle Screws with Single Instrument Pass
Currently, the MIS screw insertion technique may consist of numerous instruments, involves the use of tools like Jamshidi needles and guidewires, and requires multiple instrument passes in and out a patient’s body, all of which contribute to procedural complexity. The VIPER PRIME System combines many of these instruments into one single tool and reduces the number of instrument trays to two**. A new screw tip design and stylet that is fully controlled by the screwdriver allows surgeons to target pedicles and insert the screw in one single instrument pass. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw through an MIS technique compared to traditional techniques.5 Additionally, the system’s streamlined instrument set means a smaller procedural footprint that also helps reduce waste, processing costs and environmental impact.6

CONCORDE Clear Discectomy Tool Removes Degenerated Disc in Under Four Minutes4
Disc removal in spinal fusion surgery requires the surgeon to work through a small surgical field with limited visualization. It also typically requires multiple instruments and instrument passes to make sure the disc is cleared and the endplates of the vertebrae are prepped for implants, which increases the risk of nerve root injury. The CONCORDE Clear Device is a single-use instrument that uses standard operating room suction to remove the degenerated disc and prepare the endplates, a simplified approach that is faster on average and results in a reduction in tool passes and instrument exchanges compared to traditional techniques.4*** A clear handle enables surgeons to visualize collection of disc material.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies****, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries. MEDOS INTERNATIONAL, SARL is the legal manufacturer of the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool.
**Compared to the VIPER® 2 MIS System
***Comparing CONCORDE Clear MIS Discectomy Tool vs. traditional discectomy tools
****The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.
DSUS/SPN/1017/1674 10/17

1 Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567.
2 Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.
3 Phillips F. M., Cheng I., Rampersaud Y. R., et al. Breaking through the ‘glass ceiling’ of minimally invasive spine surgery. Spine. 2016;41, S8:S39–S43.
4 Araghi, A. Novel Technologies for MIS Fusion Discectomy and Expandable Interbody. ISASS Boston September 18-20 2015.
5 Adaptiv #103327910 (Analysis 1): Percent Reduction in Time for the Viper Prime Technique Compared to the Traditional Jamshidi/Guidewire Technique.  Bench test results may not be indicative of clinical performance.
6 Earthwards Scorecard Results: VIPER PRIME System.

SOURCE DePuy Synthes

Zimmer Biomet Announces U.S. Launch of Vitality®+ and Vital™ Spinal Fixation Systems

WARSAW, Ind.Oct. 25, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the official launch of its Vitality®+ and Vital™ Spinal Fixation Systems in the United States at the 2017 North American Spine Society (NASS) Annual Meeting.

The comprehensive Vitality+ Spinal Fixation System consists of Vitality+ POWER for simple, controlled pedicle preparation and pedicle screw insertion, Vitality+ PSO for optimal pedicle subtraction osteotomy and vertebral column resection procedures, and Vitality+ HOOKS with an extensive array of additional fixation options. In addition, the Vital Spinal Fixation System offers a compact solution for degenerative thoracolumbar procedures with its convenient, intuitive and optimized two-kit pedicle screw instrument configuration.

The launch of Vitality+ POWER follows Zimmer Biomet’s recent 510(k) clearance for pedicle preparation and screw insertion under power. The addition of power offers a significant benefit to surgeons, as compared to traditional hand-driven pedicle preparation and insertion. Vitality+ POWER features the market’s first flexible drill and a blunted reamer, both of which are designed to flex off cortical bone to ensure precision during procedures. The addition of the Vitality+ PSO system provides an extensive array of intuitive instruments for complex osteotomy procedures, including specially designed curettes, osteotomes, soft tissue manipulators and nerve root retractors.  Finally, Vitality+ HOOKS offers an assortment of hooks with various throat depths, designed for sublaminar, pedicle and transverse process fixation.

Dr. David Skaggs, a board-certified orthopaedic spine surgeon in Los Angeles, Calif., commented, “The enhancements to the Vitality System are prime examples of Zimmer Biomet’s commitment to the advancement of deformity correction. The ergonomic benefit, OR efficiencies and comprehensiveness provided by POWER, PSO and HOOKS truly support spine surgeons during procedures, and especially in complex cases, all while maintaining high quality patient care.”

The Vital Spinal Fixation System is an innovative evolution to the Vitality System. The minimized two-kit configuration includes all pertinent instruments required for degenerative spine surgeries with an easy-to-follow color-coded tray layout, which is particularly beneficial to surgeons and technicians with a small OR footprint. The upgraded Vital screws incorporate one of the largest drive standards in the industry, a T27 hexalobe drive feature designed to provide 30 percent more strength than the T25 hexalobe.* The Vital System’s dual lead screws require fewer revolutions for insertion, which improves surgical efficiency by allowing them to be inserted twice as fast as comparable single lead screws, without sacrificing pull-out strength.*

Dr. Justin Smith, a board-certified neurosurgeon in Charlottesville, Va., commented, “The Vital System’s upgraded screw and consolidated kit design offer noticeable operational efficiencies for common one- and two-level degenerative posterior thoracolumbar spine procedures. The streamlined System allows me to complete cases faster, while still providing quality patient care.”

Indications:

The Vital Spinal Fixation System is a subsystem of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition, the Vitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct®Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

Vitality+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality Spinal Fixation System screws using a power surgical technique.  Pedicle and iliac screws from the Vitality Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

*Data on file at Zimmer Biomet (TPR#00184).

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

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