SteriSpinePS.jpg

Pascale Davis, an internationally renowned expert on the spine market, joins Safe Orthopaedics as Global Head of Marketing

Posted On April 24, 2017 By OrthoSpineNews In Spine, Top Stories /  

April 24, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing the appointment of Pascale Davis, an internationally renowned expert on the spine market, as Global Head of Marketing.

Pascale is a seasoned veteran with over 18 years’ experience in marketing and scientific affairs. She worked for industry leaders including Zimmer Biomet, Synthes and SpineArt, where she acquired both marketing and scientific knowledge in Europe and in the United States.

Before joining Safe Orthopaedics, Pascale was Marketing Director for Europe, Middle East and Africa (EMEA) at Zimmer Biomet Spine, since 2012 where initially her role was EMEA Scientific Affairs Director. Previously, she held various positions of responsibility at Synthes Spine and SpineArt in Switzerland and then in the United States. Concurrently, Pascale was also Director of Education and Marketing for the International Society for Advancement of Spinal Surgery (ISASS) from 2001 until 2006.

“It gives us great pleasure to welcome Pascale to Safe Orthopaedics. Her arrival illustrates the Company’s ability to attract well-known international talents and the growing interest in its technology, as was recently demonstrated by AP-HP’s decision to list our products,” commented Pierre Dumouchel, Co-Founder and Chief Executive Officer of Safe Orthopaedics. “Pascale’s arrival will provide a significant boost to our marketing capabilities and training programs that we provide to surgeons to foster the take-up of our products and to give them more information about the benefits of Safe Orthopaedics’ sterile single-use products for both minimally-invasive and trauma surgery.”

Pascale Davis, Safe Orthopaedics’ Head of Global Marketing, added: “I’m delighted to be joining Safe Orthopaedics. Their innovative technology is highly acclaimed and respected and gaining more and more traction in France and internationally. I will be applying my market knowledge together with the experience I gained in the scientific community to accelerate adoption of our products by surgeons and centers of excellence for spinal surgery — in France, Germany and also in other European and emerging markets.”

Next report: Full-year 2016 results on Friday, April 28, 2017

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
+33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Read More
bb2ffvsd.jpg

SI-BONE, Inc. Announces Publication of 6-year Clinical Results Demonstrating Long-Term Positive Outcomes of iFuse Implant System®

Posted On April 24, 2017 By OrthoSpineNews In Spine /  

SAN JOSE, Calif., April 24, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of a 6-year study comparing the iFuse ImplantTM to both conservative management and radiofrequency denervation.  The long-term study titled Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation and Conservative Management for Sacroiliac Joint Pain: Six Year Comparative Study, was published in the journal Neurosurgery.

The study evaluated 137 patients seen in an outpatient neurosurgery clinic who received either conservative management (63 patients), SI joint denervation (47) or SI joint fusion with the iFuse Implant (27) for SI joint pain due to either osteoarthritic degenerative sacroiliitis or SI joint disruption.  Outcomes were based on SI joint pain ratings using a 0-10 visual analog scale (VAS), functional status using Oswestry Disability Index (ODI), pain medication use and work status.  Patients treated with conservative management as well as those treated with radiofrequency denervation had no long-term improvement in pain or function, and in fact got worse, whereas the iFuse Implant group had markedly superior improvements in pain (See Figure 1) and function.

Figure 1 VAS SI joint pain score
Figure 1 VAS SI joint pain score

At last follow-up, 80% of the patients in both the conservative management and radiofrequency denervation groups were using opioids, compared to only 7% of the patients in the iFuse Implant group.  At last follow-up, 70% of patients treated with the iFuse Implant had returned to work, compared to 34% of those treated with radiofrequency denervation and 19% of those treated with  conservative management.

Figure 1  VAS SI joint pain score

Publication of results of this long-term study extends the duration of follow-up out to 6 years with the iFuse Implant.  iFuse is specifically designed for SI joint fusion with a unique triangular shape that prevents rotational motion and a porous surface that promotes bony ongrowth and ingrowth1.  The iFuse Implant is the only SI joint fusion device with prospective peer-reviewed publications demonstrating safety, effectiveness and durable positive outcomes, and the only SI joint fusion device with a FDA-cleared claim that clinical studies demonstrate improvements in pain, patient function and quality of life.

“An interesting observation from our study was that over one-third of patients seen in our clinic and initially treated with conservative management failed to achieve adequate pain relief and required additional treatments.  Of the treatments available, only SI joint fusion with the iFuse Implant provided sustained, long term pain relief,” said Vicente Vanaclocha-Vanaclocha MD, PhD, primary author of the study.  “Furthermore, the fact that the treatment option provided was often decided by external factors enhanced the comparability of groups.  This study offers solid evidence that the iFuse Implant is an effective long-term treatment for those patients with chronic pain resulting from certain types of SI joint pathologies who fail to respond to initial conservative management.”

Jeffrey Dunn, President and CEO of SI-BONE commented: “This study is remarkable in that it highlights the profound positive impact on patients with SI joint pain who have access to SI joint fusion.  The opioid epidemic is a challenging public health problem in the U.S. and coverage policies that provide access to technologies like the iFuse Implant can have a meaningful impact on reducing dependence on opioids.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth1, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are more than 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

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

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9761.041017

  1. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

 

SOURCE SI-BONE, Inc.

Read More
ed4a1bda11a7817b94e0f4d7bca95b7d.jpg

MiMedx to Present at the European Wound Management Association Annual Conference

Posted On April 24, 2017 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., April 24, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today Company’s participation in the European Wound Management Association (“EWMA”) 2017 Conference to be held in Amsterdam, The Netherlands from May 3 through May 5, 2017.

The 2017 EWMA Conference is EWMA’s 27th annual conference offering high-level scientific presentations, knowledge and best practices exchange, and presentation of the most recent advances in wound management research and treatment. With up to 5,000 attendees, the EWMA is one of the largest and most prestigious wound management conferences in the world.

MiMedx will sponsor a Symposium entitled, “The Dynamic Impact of EpiFix® Dehydrated Human Amnion/Chorion Membrane Allograft – Defining the New Standard for Bioactive Healing” on May 4, 2017 from 16:00 to 17:00. Severin Läuchli, MD, will chair the symposium and Matthew Garoufalis, DPM, FASPS, FACFAOM, CWS, will be a symposium speaker. This symposium will detail published peer-reviewed clinical data, clinical case examples, and intriguing scientific evidence supporting the use of EpiFix for the treatment for acute and chronic wounds.

Symposium Chair Dr. Läuchli is the Chief of Dermatologic Surgery/Mohs Surgery and Wound Care and Assistant Professor, Department of Dermatology at the University Hospital, Zurich, Switzerland, and the President of the EWMA. Dr. Läuchli will present “The Swiss Experience with EpiFix.” Physician and study author, Dr. Garoufalis is also the President of the International Federation of Podiatrists. Dr. Garoufalis will present “Application Techniques and Therapeutic Approached Using EpiFix Amniotic Allografts for Wound Healing and Surgical Procedures.”

Parker H. “Pete” Petit, CEO, said, “We are honored to be associated with the EWMA and participate in their outstanding conference. The EWMA is focused on investigating the barriers to and possibilities of advanced therapies in the next generation of wound management. They also have a key focus on the prevention and management of surgical site infections.  Their focus is well aligned with our strategies and priorities, and we are proud to be associated with the EWMA. Our significant participation at this year’s EWMA Conference is part of our ongoing strategy to expand our presence in the international wound care markets and globally market our dHACM allografts.”

Bill Taylor, President and COO, commented, “The EWMA conducts its activities in coordination with various national and international organizations aimed at goals such as increased data collection and quality of evidence, implementation of knowledge, and development of education within wound management.  We share these goals in our pursuit of advances in the treatment and healing of acute and chronic wounds. We are excited to work with the EWMA in improving the delivery and availability of advance wound care therapies internationally.”

MiMedx will provide in-booth education during the following times:

  • May 3 from 10:30 to 18:00;
  • May 4 from 9:00 to 16:30;  and
  • May 5 from 9:00 to 14:30.

Throughout the conference, MiMedx will be located at Booth #3 C 06.

About MiMedx
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative and therapeutic biopharmaceutical products processed from donated placental tissues. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements are based on current information and belief, and are not guarantees of future performance.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include  the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

 

SOURCE MiMedx Group, Inc.

Read More
hqdefault.jpg

Stimwave Awarded U.S. Government DAPA Contract

Posted On April 24, 2017 By OrthoSpineNews In Neuro, Regulatory /  

April 21, 2017

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced it has been awarded a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency. Stimwave, which distributes the Stimwave Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System, received a five-year contract, negotiated by TAMM Net, Inc., which is the first global agreement for spinal cord stimulators by a U.S. government agency.

“We are extremely pleased Stimwave received a DAPA. The successful product validation process now allows Stimwave products to be accessed and used by doctors at all military treatment facilities across the globe,” said Laura Perryman, CEO and president of Stimwave. “Multiple facilities have been pleased to hear they can now acquire our products through their purchasing vehicles.”

Stimwave’s devices use Wireless Pain Relief® technology and are 95 percent smaller than any other neuromodulation device on the market. Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.

Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

About TAMM Net, Inc.

TAMM is a consultancy that provides services to biomedical manufacturers seeking opportunities or overcoming obstacles presented by the U.S. government. TAMM provides complete reimbursement, full federal contracting services, regulatory affairs, and facilitating sales to federal medical facilities. http://www.tammnet.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

Read More
bioventus-office.jpg

Bioventus Names David Varner Vice President of Marketing, Active Healing Therapies

Posted On April 24, 2017 By OrthoSpineNews In Biologics /  

April 24, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has named David Varner as Vice President of Marketing, Active Healing Therapies (AHT). Varner will be responsible for developing and executing global strategic marketing plans for the AHT business. He will also provide leadership to its sales training, marketing intelligence, marketing, external communications and professional affairs & medical education business functions.

“We are very pleased David is joining us to lead global marketing for our Active Healing Therapies business,” said John Nosenzo, Chief Commercial Officer, Bioventus. “His deep experience in healthcare sales, marketing and operations roles combined with his ability to create high performing teams and launch new initiatives will help Bioventus continue to develop our AHT product portfolio and accelerate our growth in orthobiologics around the world.”

Varner joins Bioventus from Beckman Coulter Diagnostics, where he served as Vice President, Global Sales Operations. Previously he worked in the Life Sciences Division of GE Healthcare in a succession of marketing and sales leadership positions, last serving as the company’s General Manager, Global Marketing Operations. Prior to that, Varner spent 13 years in a variety of sales, marketing and operations roles with Siemens Medical Diagnostics (formerly Bayer Diagnostics).

Varner earned a Bachelor of Arts from The College of William and Mary.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Read More
davinci-robotic-surgery-large1-1.jpg

Intuitive Surgical Leads China Surgical Robotics Systems Market

Posted On April 21, 2017 By OrthoSpineNews In Robotics /  

VANCOUVER, British Columbia, April 21, 2017 /PRNewswire/ — According to a new series of reports on the China surgical navigation and robotics systems market by iData Research (www.idataresearch.com), the market in China is currently dominated by Intuitive Surgical, but has seen the entrance of companies such as Medtech and Accuray, predominantly in neurosurgery and radiosurgery applications. The market as a whole is expected to increase considerably as system sales increase and revenue from procedures, maintenance and services increases as a result of the growing installed base.

“The MIS robotic device market in China is the most mature and sees Intuitive Surgical as the market leader, but several companies are developing systems which will compete with Intuitive’s system,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “As the installed base grows, the number of procedures will increase yearly, yielding a higher percentage of revenue from procedures.”

The Chinese robotic assisted surgery system market is expected to grow at a compound annual growth rate (CAGR) of over 14% through 2023 as a result of increasing adoption of robotic technologies in the neurosurgery, minimally invasive surgery (MIS), radiosurgery and spinal markets. Currently, the MIS, neurosurgery, and radiosurgery application segments are firmly established in China. Very small installed bases exist for systems with spinal applications and these are also expected to exhibit growth.

Overall, the surgical robotics market in China is still in its infancy. In addition to imported systems, several domestic companies are developing systems in a variety of procedural segments. Hong Kong has been a leading region for early system placements, with the first system, a da Vinci®, installed in Hong Kong’s Prince of Wales Hospital in 2005. As many robotics companies begin to expand partnerships with established medical device companies, sales of robotic surgery systems are expected to increase significantly. Gynecological procedures are the largest specialty of the da Vinci® system in China, followed by general surgery.

Additional competitors in the China robotic assisted surgery market include Accuray with their CyberKnife® system and Medtech who currently sells ROSA®, the only robotic surgery system approved for neurosurgical procedures by the China Food and Drug Administration (CFDA). Neurosurgical procedure applications include stereoelectroencephalography (SEEG) treatment for epilepsy, as well as hydrocephalus shunt, electrode placement, endoscopy and deep brain stimulation. It is expected that other companies will enter the Chinese market in the near future.

For Further Information

More on the surgical robotics market in China can be found in a series of reports published by iData Research entitled the China Market Report Suite for Surgical Navigation and Robotics Systems. The segmentation for surgical navigation includes systems with neurosurgery applications, spinal surgery applications, ear, nose and throat (ENT) applications, and orthopedic hip and knee applications. The segmentation for surgical robotics systems includes robotically assisted neurosurgery systems, minimally invasive surgery (MIS), robotically assisted radiosurgery systems and an appendix with qualitative data regarding robotically assisted spinal surgery systems.

The iData report series on robotic surgery systems covers the U.S., China, Australia, Japan, India and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about robotic surgery systems market data, register online or email us at info@idataresearch.net for a China Market Report Suite for Surgical Navigation and Robotics Systems brochure and synopsis.

About iData Research

iData Research (www.idataresearch.com) is an international market research and consulting firm, dedicated to providing the best in business intelligence for the medical device industry. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Endoscopy, Dental Operatory Equipment, Dental Material, Dental Lasers, Dental Prosthetics, Dental CAD/CAM, Dental Bone Graft Substitutes, Ophthalmics, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Vascular Access, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Operating Room Equipment, Surgical Microscopes, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics and more.

We have built a reputation and earned our clients’ trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.

Contact Info
Marvin Cidamon
Marketing Coordinator
iData Research Inc.
604-266-6933 Ext. 205
marvinc@idataresearch.net

 

SOURCE iData Research

Related Links

https://www.idataresearch.com

Read More
duke-university-3d-printed-cartilage-mimicking-hydrogels-could-repair-damaged-knees-1.jpg

3-D Printable Implants May Ease Damaged Knees

Posted On April 21, 2017 By OrthoSpineNews In Biologics, Top Stories /  

PUBLISHED IN  – By KARA MANKE

A cartilage-mimicking material created by researchers at Duke University may one day allow surgeons to 3-D print replacement knee parts that are custom-shaped to each patient’s anatomy.

Human knees come with a pair of built-in shock absorbers called the menisci. These ear-shaped hunks of cartilage, nestled between the thigh and shin bones, cushion every step we take. But a lifetime of wear-and-tear — or a single wrong step during a game of soccer or tennis — can permanently damage these key supports, leading to pain and an increased risk of developing arthritis.

The hydrogel-based material the researchers developed is the first to match human cartilage in strength and elasticity while also remaining 3-D-printable and stable inside the body. To demonstrate how it might work, the researchers used a $300 3-D printer to create custom menisci for a plastic model of a knee.

“We’ve made it very easy now for anyone to print something that is pretty close in its mechanical properties to cartilage, in a relatively simple and inexpensive process,” said Benjamin Wiley, an associate professor of chemistry at Duke and author on the paper, which appears online in ACS Biomaterials Science and Engineering.

After we reach adulthood, the meniscus has limited ability to heal on its own. Surgeons can attempt to repair a torn or damaged meniscus, but often it must be partially or completely removed. Available implants either do not match the strength and elasticity of the original cartilage, or are not biocompatible, meaning they do not support the growth of cells to encourage healing around the site.

Recently, materials called hydrogels have been gaining traction as a replacement for lost cartilage. Hydrogels are biocompatible and share a very similar molecular structure to cartilage: if you zoom in on either, you’ll find a web of long string-like molecules with water molecules wedged into the gaps.

READ THE REST HERE

Read More
AM_Stryker-1.png

Stryker’s Spine Division to Feature Comprehensive Product Portfolio at AANS 2017 Conference

Posted On April 21, 2017 By OrthoSpineNews In Spine /  

April 21, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will exhibit its comprehensive suite of spinal products at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, April 22–26, 2017, at the Los Angeles Convention Center (booth No. 1301). This exhibition includes a number of advanced spinal products and technologies that Stryker’s Spine division has introduced in the past year. The company also will offer a Lunch-and-Learn educational program for AANS members attending the meeting.

“This is an exciting time, both for the field of spinal surgery and for Stryker’s Spine division,” said Bradley Paddock, President of the company’s Spine division. “Our expanding portfolio of spinal procedural innovations and differentiated technologies demonstrates our commitment to bringing state-of-the-art products to physicians and their patients. We will continue to increase and strengthen our leadership position in this segment and are thrilled to showcase our latest technology advances at the AANS conference.”

Stryker’s Spine division’s products offer advancements for both traditional and minimally invasive surgical techniques. Recently introduced technologies that will be highlighted at the meeting include:

  • The Tritanium Posterior Lumbar (PL) Cage, a 3D-printed interbody fusion device designed to aid in lumbar spinal fixation for patients with degenerative disc disease, including up to Grade 1 spondylolisthesis, and degenerative scoliosis. It is manufactured using Stryker’s proprietary Tritanium Technology, which allows for the creation of porous structures that are designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.1 The cage is now offered in a variety of new sizes, which were introduced at the 2017 AAOS conference in March.
  • Aero-C Cervical Stability System (Aero-C), the only StraightForward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space.2 Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.2
  • Xia CT (Xia 4.5 Cortical Trajectory), which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.3 It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.3
  • The LITe BIO Delivery System, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites, simplifies graft delivery, accommodates a surgeon’s preferred graft materials,4 and allows for direct visualization of graft placement. The unique design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

Stryker’s Spine division will host the Lunch-and-Learn seminar, “Tritanium: A Novel Highly Porous Titanium Alloy for Interbody Fusion Procedures,” Monday, April 24 from 1:10–1:55 p.m. The seminar will be presented by Matthew J. McGirt, M.D., from the Department of Neurosurgery at the University of North Carolina.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

References

1. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
2. PROJ0000050417 Aero-C Anchor Induced Compression Testing Design Iteration Memo
3. Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.
4. FDA Cleared Indications for Use: The LITe BIO Delivery System is intended to deliver autograft, allograft or synthetic bone graft materials to all orthopaedic surgical sites.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Aero, Aerofoil, LITe, StraightForward, Stryker, Tritanium, and Xia. All other trademarks are trademarks of their respective owners or holders.

Content ID TRITA-PR-7_13958

Contacts

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

Read More
drop-back-series-suture-strand.jpg

Ziptek LLC Receives FDA Approval For ZipE®, the Innovative Knotless Tissue Repair Device

Posted On April 21, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

By on April 20, 2017

Ziptek LLC, founded by Sarasota-based orthopedic surgeon Dr. William Bennett M.D., is proud to announce its newly obtained FDA-approval for the ZipE® knotless tissue repair and attachment device. ZipE® is an absorbable button that moves down a suture, locking itself from moving backward with each forward movement. It can be used in minimally-invasive techniques and open surgeries to accomplish tissue-to-tissue and tissue-to-bone repair. Most importantly, since it functions similar to a zip tie, ZipE® prevents the need to tie knots in small spaces and creates a superior contact of the repaired tissue compared to any other device on the market.

Ziptek LLC exhibited at the March 2017 AAOS Meeting in San Diego and garnered significant national and international interest by surgeons and distributors alike for the newly FDA-approved ZipE®. Given that the U.S soft tissue repair market generates $2 to $3 billion per year, with at least 500,000 rotator cuff and 1,000,000 ankle ligament cases annually, the ZipE® can play a major role in transforming the surgical outcomes of countless patients. It offers the unprecedented ability to disperse pressure across a larger surface area and help prevent the suture from tearing out through the tissue. This makes ZipE® incredibly valuable for better and improved tissue healing with a far lower rate of non-healing and re-tears.

 

 

READ THE REST HERE

Read More
7d-surgical-7x4.jpg

7D Surgical Enters Into Key Distribution Agreements in the United States for Its Breakthrough Image Guidance System for Spine Surgery

Posted On April 21, 2017 By OrthoSpineNews In Spine, Top Stories /  

TORONTO, April 20, 2017 /PRNewswire/ — 7D Surgical, developer of ground breaking surgical navigation technologies, announced today that it has entered into exclusive sales representative agreements with two premier American medical device distributors covering key strategic geographies in the United States.  Surgical One Inc. will represent 7D Surgical in several states from the Midwest to the Gulf Coast, while DB Surgical will cover the southeast U.S., including the important medical device markets in Florida.

“Proven distribution partners, such as Surgical One and DB Surgical, will complement our direct sales force in the commercialization of the MvIGS technology for the execution of our rapid growth strategy,” said Beau Standish, Chief Executive Officer of 7D Surgical.  “Both companies have the infrastructure, footprint and existing relationships that are required to effectively promote the benefits of 7D Surgical’s fast, cost effective and radiation-free image guided spine surgery to a large and underserved market.”

The 7D Surgical System is the first and only Machine-Vision Image Guided Surgery (MvIGS) platform. For the first-time spine surgery patients can be quickly, easily and automatically registered using only visible light and 7D Surgical’s Flash RegistrationTM technology. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new MvIGS platform can achieve an incredibly fast surgical workflow for spine procedures. 7D Surgical anticipates adding additional qualified distribution partners in coming months.

“When Surgical One learned about the new MvIGS system, we recognized immediately that the 7D Surgical technology had erased the traditional barriers to spinal image guidance adoption and the low utilization of existing alternatives,” said Al Ludvigsen, President of Surgical One Inc. “We are thrilled to exclusively represent this fast, radiation-free solution for spinal image guidance to the clinicians and patients we support.”

“While spinal image guidance had been shown in studies to reduce surgical complications, we have yet to see widespread adoption of existing technologies among spinal surgeons,” said Debbie Burg, President of DB Surgical.  “We see the introduction of the 7D Surgical System MvIGS technology as a game-changer with the potential to finally expand the use of IGS in spine surgery.”

About 7D Surgical

7D Surgical is a privately owned Toronto-based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada-approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.  www.7Dsurgical.com

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
155698@email4pr.com

About Surgical One, Inc.

SurgicalOne, Inc. is the premier surgical specialty distribution company in the Midwest to Midsouth. Our 30 direct employees cover 10 total states, with sales representatives and service repair technicians in each major market. We represent the top tier, finest microsurgical, neurosurgical and spinal product manufacturers in the world. Since our founding in 2000, we have maintained a relentless, singular focus on patients, surgical clinicians and medical facility administrators. Our ultimate goal is improved patient outcomes, combined with the highest level of clinician satisfaction. www.surgicalone.com

About DB Surgical

DB Surgical is dedicated to bringing transformational surgical technologies to hospitals and surgery centers. The company focuses on introducing tools that enable surgeons to advance patient outcomes beyond those available today. Since 1997, DB Surgical has worked with industry-leading surgeons to understand and meet the evolving needs of healthcare providers. The company is based in Coral Springs, FL and has 18 professionals located throughout Florida, Georgia, and Alabama focusing on the Neuro, Spine, ENT, Cardiovascular, Ophthalmic, and Plastic Reconstructive surgical disciplines. In addition to providing cutting-edge technologies, DB Surgical also offers a complete line of specialty surgical products designed to create value within the healthcare supply chain. www.DBSurgical.com.

Contact:
Phone: 954-340-2727
Fax: 954-340-1221
Email: sales@dbsurgical.com

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“Flash Registration™,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical.

SOURCE 7D Surgical

Related Links

http://www.7Dsurgical.com

Read More