News – Page 223 – Selby Spine

DUBLIN – March 14, 2017 – Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon(TM) Xpede Bone Cement for fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty – expanding the product’s indications beyond treatment of vertebral fractures due to osteoporosis, cancer or benign lesions.

Sacral insufficiency fractures (SIFs) are a common cause of debilitating lower back pain in the elderly, with incidence ranging from 1 to 5 percent in at-risk populations.^1,2 According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis and low bone mass, placing them at increased risk for a fracture. Breaking a bone is a serious complication of osteoporosis, especially with older patients. Osteoporotic bone breaks are most likely to occur in the hip, spine or wrist, but other bones can break, too – including the sacrum.³

“Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them,” said Dr. Douglas Beall, chief of Radiology Services at Clinical Radiology of Oklahoma. “Having this new indication with Kyphon Xpede Bone Cement to use in the treatment of sacral fractures will help to address this patient population.”

A recent multi-center retrospective study of 243 patients with osteoporotic SIFs treated with sacroplasty reported significant pain relief for patients immediately following the procedure and after one-year follow-up; authors indicated that there were no major complications or procedure related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4 percent) having symptomatic leakage requiring decompression.²

“We are pleased to expand our therapies for interventional physicians treating osteoporotic patients to include those suffering from sacral insufficiency fractures,” said Jeff Cambra, general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “As the pioneers in balloon kyphoplasty for treating vertebral compression fractures, this expanded indication for Kyphon Xpede Bone Cement demonstrates our long-term commitment to continuously innovate and empower physicians to deliver the best clinical solutions to their patients.”

Kyphon Xpede Bone Cement is a quick-to-dough bone cement that provides ease of handling and allows sufficient time for careful, minimally invasive use. When paired with the Kyphon(TM) Cement Delivery System, clinicians can minimize their radiation exposure by standing up to four feet away from the radiation source during injection, which has been measured to reduce hand radiation exposure by 70 percent.⁴

About Sacral Insufficiency Fractures
Sacral insufficiency fractures (SIFs) are a common cause of debilitating back pain. SIFs mimic the symptoms of lumbar spine pathology and are commonly missed or underdiagnosed. Since the sacral ala is composed predominantly of cancellous bone – the first to be reduced in cases of osteoporosis and other metabolic conditions – it remains the most common region for SIFs.^1,2

About Kyphon Xpede Bone Cement
Kyphon Xpede Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:

Cardiac arrest
Cerebrovascular accident
Myocardial infarction
Pulmonary embolism
Cardiac embolism

Payer coverage for sacroplasty may vary. Medtronic recommends providers review all payer coverage policies and/or call payers to determine coverage criteria and appropriate coding.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.

-end-

Sudhir G., et al. Sacral Insufficiency Fractures Mimicking Lumbar Spine Pathology. Asian Spine J 2016;10(3):558-564
Kortman K, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013 Sep 1;5(5):461-6.
National Osteoporosis Foundation Website. www.nof.org
Medtronic data on file. The mean radiation reduction at the hands was 77.79 percent (p<0.001). Based on an internal testing of 24 total cadaveric procedures (n=12 using Kyphon(TM) CDS and n=12 using Kyphon(TM) Bone Filler Device). Dosimeters were placed on the wrist and fingers to measure radiation when delivering bone cement into the vertebral body. Radiation result reported is based on adherence to the Directions for Use.

Contacts:
Victor Rocha
Public Relations
+1-901-399-2401

Ryan Weispfennig
Investor Relations
+1-763-505-4626

SAN DIEGO, March 14, 2017 /PRNewswire/ — Every patient moves differently, and now surgeons can take this into account when performing hip replacement surgery thanks to a new technology from Corin Group that helps determine the best positioning of an implant and its components based on how patients really move during daily activities.

Corin announced the U.S. launch of its Optimized Positioning System (OPS™) System at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego. The technology may lead to one of the most significant changes to the way hip replacements are performed in more than 30 years.

“This new technology challenges the traditional approach of placing implants in generic safe zones,” said James Huddleston III, MD, associate professor of orthopaedic surgery at the Stanford University Medical Center. “Now we can get more specific and tailor the implant position for each patient. This should help reduce the dislocation rate and even possibly reduce wear.”

Utilizing pre-operative functional simulation and planning and a unique intra-operative positioning system that employs 3D printing and laser guidance, OPS helps surgeons determine the best position and orientation for a hip implant based on specific patient anatomy and movement.

“While hip replacement surgery is considered one of the most successful operations in medical history, we are always looking for ways to improve it, particularly ways we can improve function and performance and reduce the potential for dislocation and premature wear of bearing surfaces,” said Douglas Dennis, MD, an orthopaedic surgeon in Denver, CO. “This new technology may be an advance that helps us do this.”

In the U.S., the first-ever functional, patient-specific hip replacement procedures using OPS were performed in November 2016, shortly after FDA clearance. More than 3,000 procedures have been done in Europe and Australia, where the system was previously approved for use.

“No two patients are the same. We are offering a patient-specific solution that gives the surgeon the information and tools necessary to enable an optimal hip replacement procedure,” said Paul Berman, President Corin USA. “Feedback from surgeons who have used OPS has been excellent and interest in the system from the orthopaedic community is very high.”

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements
…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization
…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

This news release contains forward-looking statements. These statements appear in a number of places in this news release and include statements regarding our intentions, beliefs or current expectations, concerning, among other things, our results of operations, turnover, financial condition, liquidity, prospects, growth, strategies, new products, the level of new launches and the markets in which we operate. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ markedly from those in the forward-looking statements as a result of various factors. We undertake no obligation publicly to revise any forward-looking statements, except as may be required by law.

SOURCE Corin USA

Related Links

http://www.coringroup.com

WARSAW, Ind., March 14, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced plans to highlight its latest commercial offerings and preview its next generation of technological innovations at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting this week in San Diego, CA. The Company’s state-of-the-art booth (#4333) will feature an immersive and interactive tour of its newly launched digital technology and clinical services offering, Zimmer Biomet Signature Solutions, alongside more than 50 new products from its vast and diversified portfolio.

“We’re proud and excited to showcase our most innovative new commercial offerings to the largest gathering of orthopaedic professionals,” said David Dvorak, President and CEO of Zimmer Biomet. “New this year is a virtual booth experience designed to bring Zimmer Biomet Signature Solutions to life through a guided tour, a sneak preview of our emerging robotics platform and other technologies in our deep pipeline.”

Following is a snapshot of the key highlights being featured at the Zimmer Biomet booth (#4333) at AAOS 2017:

Zimmer Biomet Signature Solutions
- Guided tours through the virtual experience every 15 minutes. Members of the press can reserve a spot by contacting Monica Kendrick at monica.kendrick@zimmerbiomet.com.
Robotic Technology
- Catch a glimpse of the future of personalization and intelligent instrument technology through innovative robotics.ⁱ
Knees
- Vanguard^® Individualized Design (ID), advances soft tissue preservation and balancing through independent medial and lateral articular surface constraint and thickness options.
- OSS^TM Orthopedic Salvage System, a comprehensive modular platform providing surgeons with intraoperative flexibility often required during limb salvage procedures.
- Persona^® Medial Congruent^® Bearing, designed to recreate more natural feeling motion of the human knee by maximizing knee joint stability while allowing mobility.
Hips
- Hip Preservation portfolio of options designed to treat conditions leading up to osteoarthritis and potentially preventing the need for total hip replacement.
- Trabecular Metal^TM acetabular cups, which National Joint Registry analysis has recently shown are 21 percent less likely to be re-revised due to infection (statistically significant, p-value=0.036).ⁱⁱ
- The latest in dual mobility, Microplasty^® and revision implant options designed to address the distinct needs of individual patients while simplifying surgical workflow.
Personalized Solutions
- A comprehensive technology-based portfolio of guides, tools and software to support surgical planning, intraoperative guidance and optimal component placement.
Bone Cement
- StageOne^TM and StageOne Select Spacer Molds, designed to mold a temporary knee, hip and shoulder spacer for patients undergoing a two stage revision due to an infected total joint.
Diagnostics
- Synovasure^® Laboratory Panel for the detection of Periprosthetic Joint Infection (PJI), now includes Microbial ID. These diagnostic tests provide a fast and easy method to diagnose PJI based on the flagship test, which determines the concentration of Alpha Defensin in synovial fluid. Microbial ID detects the presence of microbes in the synovial fluid in a matter of hours.
Extremities
- Vault Reconstruction System (VRS), the first commercially available patient-matched glenoid implant, cleared to specifically treat patients with severe glenoid bone loss and a deficient rotator cuff.
- L2L^TM Radial Head System, a simple, smooth design solution for replacing the proximal radial head in patients with fractures.
Foot and Ankle
- Deformity correcting products available through our partnership with Nextremity Solutions, Inc., including the Nextra^®Hammertoe Correction System, the MSP™ Metatarsal Shortening System and the Re+Line^® Bunion Correction System.
- Subchondroplasty^® Procedure for foot and ankle surgery, a minimally invasive outpatient intervention that addresses the defects associated with subchondral bone marrow lesions.
Trauma
- A.L.P.S.^® Proximal Humerus Plating System, designed to minimize the risk of complications commonly associated with proximal humerus fractures, such as varus collapse, articular screw penetration and subacromial impingement.
- N-Force Fixation System^® with N-Force Blue, an augmented fixation system, integrating fenestrated screws and a Bone Substitute Material into a single construct to provide improved metaphyseal void fill and increase structural support of the implant.
- RibFix Blu^® Thoracic Fixation System, designed and used for the stabilization and rigid fixation of fractures in the chest wall, including sternal reconstructive surgical procedures, trauma or planned osteotomies.
Sports Medicine
- Quattro^® Link, a knotless anchor that brings control and efficiency to soft tissue repair.
- BioWick^TM SureLock^®, a rotator cuff implant that is an interpositional bioresorbable scaffold wick.
- SpeedSnare^TM Surgical Suture Passer, which allows the ability to pass a suture through single or multiple ports.
- Gel-One^® Cross-Linked Hyaluronate, the first low-volume viscosupplement available in a single-injection formula, for the treatment of pain in osteoarthritis of the knee that does not respond adequately to other conservative treatments.
Biologics
- nSTRIDE^® Autologous Protein Solution (ex-US use only), a single-shot autologous anti-inflammatory for treatment of knee osteoarthritis.
- AmnioFlo^TM, allograft derived from human amniotic fluid, for joint cushioning and lubrication.
Surgical
- The IntelliCart™ System Duo Fluid Carts, the foundation for infectious waste technology with market-leading 34-liter capacity, extra quiet vacuum pump, clog-free suction manifolds and portable smoke evacuation.
- Bactisure™ Wound Lavage, clear, low-odor, aqueous solution designed to remove structurally resistant forms of bacteria, including biofilms, on all wound types.
- The VasoPress^® System, reduces the risk of blood clots associated with deep vein thrombosis by propelling the venous blood out of the deep veins while patients are undergoing surgical procedures or immobile for an extended period of time.
Spine
- Mobi-C^® Cervical Disc, the first cervical disc replacement device approved for both one and two-level procedures.
- Vitality^® Spinal Fixation System, an adaptable system designed for spinal fixation in complex thoracolumbar procedures.

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 news 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 and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the 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. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, 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 news release.

ⁱ Concept device – not for sale in the US

ⁱⁱ 1. According to NJR data from 2003 to 2015 where 9,573 Trabecular Metal and 30,452 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (OA/non-OA).

2. NJR data shows a higher percentage of TM cups were used with antibiotic bone cement compared to all other non-TM cementless cups.

SOURCE Zimmer Biomet Holdings, Inc.

March 15, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Global Extremities Market with Focus on Shoulder Implants: Industry Analysis & Outlook (2017-2021)” report to their offering.

The global extremity market is expected to grow in the future due to the increasing ageing population and obese population, rise in health expenditure and rising diabetic prevalence. Key trends of this market include adoption of minimally invasive surgeries & pre-operative/intra-operative planning software, rising demand of reverse shoulder implants and low reimbursement pressure. However, there are some factors which can hinder the market growth including post-surgery complications and shortage of trained surgeons.

The U.S. was a major contributor in the global extremity market, supported by a rise in sports injuries among young people and increasing cases of osteoarthritis and osteoporosis. The U.S. is likely to experience upcoming growth of the extremity market with technological innovations and rising procedural volume growth in the shoulder extremity segment. Also, the shoulder extremity segment was the largest contributor of the extremity market in the U.S. and is likely to bring growth in the future with increasing numbers of reverse shoulder and stemless shoulder procedures.

The report profiles the key players of the market, including Zimmer Biomet, Johnson & Johnson, Exactech Inc. & Wright Medical Group N.V.

Market Dynamics

Growth Drivers

Increase in Ageing Populace
Rise in Healthcare Expenditure
Increase in Obese Population
Increase in Diabetic Prevalence
Active Lifestyle in Young Demographic
Increasing Awareness of Extremity Treatment

Key Trends

Adoption of Minimally Invasive Surgeries
Pre-Operative/Intra-Operative Planning Software in Shoulder Cases
Low Reimbursement Pressure
Mergers and Acquisitions
Rising Demand for Reverse Shoulder Implants

Challenges

Post-Surgery Complication
Shortage of Trained Surgeons

Companies Mentioned

Exactech, Inc.
Johnson & Johnson
Wright Medical Group N.V.
Zimmer Biomet Holding Inc.

For more information about this report visit http://www.researchandmarkets.com/research/zqp9z6/global.

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For EST Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Orthopedic Devices

March 14, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today its lineup of products to be showcased at the company’s educational exhibit, Booth #1433, at the American Academy of Orthopedic Surgeons (AAOS) 2017 Annual Meeting, March 15-17 in San Diego, Calif.

Highlights of Exactech’s latest innovations include:

ExactechGPS®, a compact, surgeon-controlled computer-assisted surgical technology that delivers reproducible results in total joint arthroplasty, expands its offerings with new knee applications, as well as the first application for total shoulder arthroplasty*. Live demonstrations will take place throughout the event.
The Equinoxe® Humeral Reconstruction Prosthesis offers a unique and stable solution for complex and challenging shoulder arthroplasty cases with significant humeral bone loss.** Also featured will be the new Preserve Stem, a conservative treatment option designed for preserving humeral bone.
The Vantage® Total Ankle System is Exactech’s first product in the foot and ankle market. The system features both tibial and talar components, which were designed for minimal bone resection and optimal support for the anatomically shaped implant.
The Optetrak Logic® CC Revision Knee System offers a comprehensive portfolio to help surgeons address challenging revision cases. Exactech’s redesigned, intuitive instrumentation for an efficient, streamlined surgical experience will also be showcased.
The Alteon® Monobloc Revision Femoral Stem is a press-fit, distally fixed, one-piece tapered, splined titanium stem. It incorporates specific philosophies designed to improve surgical experiences and clinical outcomes for hip arthroplasty patients.
The InterSpace® Tapered Wedge Hip Spacer and data behind InterSpace’s preformed spacer technology with 20 years of clinical experience will be showcased. The AcuDriver® Automated Osteotome Handpiece for implant removal will be featured in live demonstrations.
Ossilix® is a high performance, next generation calcium phosphate cement indicated for filling bony defects in cancellous bone. Ossilix is fast- and hardsetting within approximately six minutes in a 37°F wet environment. Once set, it can be drilled and inserted with screws. In addition, the Biologics offerings will include Reveille™ Cartilage Processor, a cost effective option for single stage surgery with autologous cartilage. Reveille is used for intra-operative resizing of autologous tissue into usable particles.

Exactech will showcase new clinical data in the Journal of Shoulder and Elbow Surgery Compendium of Shoulder Outcomes and Research and Exactech Knee Scientific and Clinical Evidence booklet. Scientists and surgeon consultants will be available to discuss the articles, as well as share their experiences on all of the company’s latest product innovations. Attendees may also learn about Exactech’s patient education and practice marketing program at the booth.

Visit www.exac.com/academy for more information on featured products, scheduled clinical experts and live demonstrations.

*The ExactechGPS Total Shoulder Application is currently undergoing premarket review by the FDA. It is intended for use during preoperative planning and during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

**The Equinoxe Humeral Reconstruction Prosthesis is not indicated for use with the reverse shoulder components in oncology applications.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Media contacts
Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

By ARUNDHATI PARMAR – MedCity News

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Japan and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

READ THE REST HERE

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of the first study of the company’s collagen-based Bioinductive Implant on patients with large and massive rotator cuff tears. The results, which were presented at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego, showed the Bioinductive Implant induced new tissue formation in all study participants.

“Failure of large and revision rotator cuff repairs continues to be a challenging problem,” said Felix H. “Buddy” Savoie, MD, study investigator and chairman of the Department of Orthopedics at Tulane University School of Medicine in New Orleans. “This study is exciting for the field of rotator cuff repair, as it showed that the Bioinductive Implant induces new tissue formation and assists in healing for patients with large and massive rotator cuff tears.”

The study enrolled 23 patients – 11 with large (two tendon) and 12 with massive (three tendon) rotator cuff tears – 16 of whom had previous rotator cuff repairs. All patients received the Rotation Medical Bioinductive Implant via arthroscopic surgery. New tissue formation was observed in all 23 patients, and 22 successfully healed their rotator cuffs. Postoperative ultrasound was used to assess tendon thickness at three, six and 12 months, and MRIs were taken at six and 12 months to confirm healing and tendon thickness. Rotator cuff thickness ranged from 5-9 mm at most recent follow-up, and all clinical scores improved significantly over time.

“Results of this study are consistent with the biopsy study published last month in Arthroscopy showing that our Bioinductive Implant promotes the growth of tendon-like tissue,” said Martha Shadan, president and CEO of Rotation Medical. “There is a growing body of evidence demonstrating that the Rotation Medical Rotator cuff system has the potential to transform the treatment of rotator cuff disease by addressing both the biomechanics and biology required to heal a rotator cuff tendon tear.”

The study, “Preliminary Investigation of a Bio-Inductive Collagen Patch used on Large/Massive Rotator Cuff Tears,” adds to the growing body of literature supporting the use of the Bioinductive Implant as a novel and effective treatment for rotator cuff tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.

For important safety information, visit http://rotationmedical.com/our-solution/risks/.

Rotation Medical is also exhibiting at the meeting in Booth #5916.

About Rotator Cuff Tears

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.

About the Rotation Medical Bioinductive Implant

Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit www.rotationmedical.com.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

OVERLAND PARK, KANSAS (PRWEB) MARCH 14, 2017

Spinal Simplicity, a medical device company developing innovative solutions to treat complex spinal and orthopedic surgical problems, announces Gary Henley has agreed to serve as an Advisor and will join the Company’s Board of Managers.

Gary Henley is an accomplished medical device executive with over 34 years of experience in the orthopedic industry. Most recently, Mr. Henley served as President, Chief Executive Officer and Board Member of United Orthopedic Group from 2011 to 2014. Prior to United Orthopedic Group, Mr. Henley served as President and Chief Executive Officer of Wright Medical Group, Inc. from 2006 to 2011. Mr. Henley also spent nine years at Orthofix International N.V. as President of its Americas Division from 1997 through 2006. Early in his career, Mr. Henley successfully created Cecorp, Inc., a surgical visualization pioneer in the arthroscopic and endoscopic markets and then sold the company to Smith & Nephew. After the sale in 1987, Mr. Henley served as President of Smith & Nephew’s Endoscopy Video Division until 1996. Mr. Henley has significant board experience, including Board Chairman of OrthoAlign, with similar roles at Orchid Orthopedic Solutions, Hutchinson Technology, Wright Medical Group, Innovative Spinal Technologies, and BioFuse Medical.

Todd Moseley, CEO of Spinal Simplicity said, “Gary’s decision to join Spinal Simplicity [as an Advisor and Member of our Board of Managers] reinforces our position that our innovative technology in the orthopedic and spine markets will bring about sweeping enhancements to the treatment options available to patients. Gary has successfully orchestrated transactions and built critical mass within companies that have dominated the spinal and orthopedic markets. Spinal Simplicity will benefit greatly from the industry expertise and healthcare-related innovations that have been the hallmark of Gary’s career. The fact that we can tap into Gary’s experience as we bring the Minuteman® G3-R to the minimally-invasive spine market will truly change the landscape of posterior supplemental fusion and fixation. Equally critical is the fact that Gary’s expertise in the extremities space will be invaluable to the company during development of the Wolff’s LawTM plating technology.”

Mr. Henley added, “I am excited about joining Spinal Simplicity’s Board. I think they have some very compelling technology in their products that will bring better clinical outcomes for patients, while also reducing the cost of doing certain procedures. It is going to be fun being part of the team that is bringing these innovative products to market.”

Spinal Simplicity’s Minuteman® family of sterile packed, posterior, non-pedicle supplemental fusion and fixation devices for use in the non-cervical spine (T1-S1) provide an alternative to traditional fixation, such as pedicle screws. The Minuteman® family of devices consists of a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor.

Spinal Simplicity will be exhibiting at the 2017 American Academy of Orthopaedic Surgeons meeting in San Diego, booth 659.

About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal and orthopedic problems. Spinal Simplicity has regulatory clearance for the Minuteman® system in the US, Europe and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com

March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced that its Exprt® Revision Hip portfolio received market clearance by the U.S. Food and Drug Administration. Exprt® Revision Hip is the latest addition to DJO Global’s Exprt® portfolio – a platform defying conventional approaches to total joint implants by improving outdated designs, focusing on patient outcomes and reinventing traditional price points.

The 12,000 surgeons expected to attend this year’s Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS booth #1733) in San Diego, CA will have an opportunity to preview the full-line, modular femoral stem inspired by the clinical success of Wagner-style predecessors. The system’s intuitive design and premium quality is based on extensive research and development that redefines revision total hip arthroplasty by offering an anatomically inspired design that has an emphasis on efficiency and strength – all for 40-70% of the price of comparable revision hip systems.

“One of the biggest challenges our healthcare system encounters is introducing modern technologies at increased price points. The latest addition to the Exprt portfolio signifies our deep commitment to not only clinical outcomes, but both surgical and cost efficiencies,” said Mark Russell, Senior Vice President of the Surgical division of DJO Global.

The two-tray revision system represents an 80-90% reduction in instruments compared to competitive systems. Streamlined instrumentation translates into less money and time spent on sterilization, less overall time in the operating suite, and less storage space – appropriate for both hospital and ASC settings.

Exprt Revision Hip was developed in partnership with industry leading physicians. Michael Taunton, M.D. at the Mayo Clinic and design team member of the Exprt Platform was one of the first surgeons to implant the device. “Having a thoughtful approach to introducing new technology in today’s healthcare landscape will drive shifts in the market place. We designed DJO Global’s Exprt Revision Hip and Knee Systems to challenge conventional approaches to revision arthroplasty. These systems allow me to do what I used to think wasn’t possible – treat my patients with a high-quality implant with improved surgical efficiency and reproducible outcomes while simultaneously being economically responsible.”

For more information on the Exprt portfolio – including Revision Hip and Knee – please visit: www.exprtprecision.com

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for the success of the Exprt® product portfolio. The words “believe,” “will,” “should,” “expect,” ”target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause the results of the Exprt Hip products and other Exprt portfolio products to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the complexities and uncertainties associated with the development of new products; the uncertainties associated with acceptance of the new products by surgeons and patients; new product introduction and other business strategies relative to our Surgical Implant segment; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 25, 2016. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760-734-3075
ir@djoglobal.com

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March 15, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, today launched OA Reaction TriFit™ Knee brace from DonJoy – the company’s latest OA knee brace designed to provide much needed pain relief to those who suffer from the incurable, degenerative joint disease that affects more than 11 million¹Americans. TriFit, from DonJoy, is designed to provide pain relief to individuals who suffer from moderate to severe Knee OA caused from an active lifestyle (overuse), suffer from excess body weight (obesity) or who are suffering from the effects of aging.

The most common type of arthritis, Knee OA, occurs when the cartilage which provides cushioning within the joints, wears down over time, resulting in bone-on-bone rubbing, which causes stiffness, pain, swelling, decreased mobility and bone spurs. OA is a condition that develops slowly, yet can become increasingly worse over time and may result in additional medical issues such as diabetes, heart disease and vascular problems if not addressed in its early stages. The knee is commonly affected by OA at a cost of $128 billion² to healthcare.

“With more than 40 percent of knee replacements occurring in patients over the age of 65 and the average onset of knee OA occurring at the age of 55³, there is an inherent need for non-invasive, non-addictive methods to control pain and to support maintaining an active lifestyle,” said Steve Ingel, President of Bracing & Supports at DJO Global. “With the onset of knee pain people tend to reduce their activity levels when the most important thing they can do to slow the progression of the disease is to remain active. Fortunately, the advanced low profile comfort of TriFit, provides a solution that aids in pain relief and helps keep patients moving.”

TriFit by DonJoy features three unique technologies that together provide a custom fit to allow OA sufferers to move freely without pain so they can participate in light to heavy activities.

Web Tech™ is a shock absorber that assists with full knee extension and patellofemoral (PF) tracking
Exos® Tech provides a heat thermoformable custom fit that hugs perfectly around the knee (thigh and the shin or above and below the knee)
Boa® Tech uses a micro tension adjustment system that pulls everything together and provides three-dimensional protection

When compared to non-treatment, active use of bracing such as TriFit can slow the progression of Knee OA or other serious knee injuries enabling ongoing activity.

To learn more about your bracing options or to order TriFit, contact your general physician. To see all of DonJoy’s new technologies visit www.djoglobal.com

Individual results may vary.

Neither DJO Global, Inc. nor any of its subsidiaries dispense medical advice. The contents of this press release do not constitute medical, legal, or any other type of professional advice. Information related to various health, medical, and fitness conditions and their treatment is not meant to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF^TM, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and Exos^TM. For additional information on the Company, please visit www.DJOglobal.com.

Social Media:

Facebook: /donjoy

Twitter: @donjoy

References:

Contacts

Chloe Canta (The Brand Amp)
chloe@thebrandamp.com
949.438.1083

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