November 30, 2018

PLAINSBORO, N.J., Nov. 20, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced one of the first surgeries with the Integra® XT Revision Total Ankle Replacement System.

“Integra’s new total ankle revision system is designed to provide surgeons with stable tibial fixation through a narrow, finned tibia. I appreciate the anterior surgical approach, which is mindful of the blood supply,” said Dr. Christopher Ritter, a foot and ankle surgeon in Buffalo, New York. “I have performed several revision procedures with the XT Revision System and found that it is easy to implant and provides stable fixation. My patients are happy with their early outcomes.”

The Integra XT Revision Total Ankle Replacement System is one of the first FDA cleared devices indicated for revision ankle arthroplasty only and can be used to revise any commercially available primary total ankle replacement system. Key implant features include:

• An augmented posterior sloped talus which addresses subsidence by rebuilding posterior talar height.
• An anatomic design that mimics the natural kinematics of the ankle, designed to promote a more normal gait and better overall function post-operatively.

“The launch of the Integra XT Revision Total Ankle Replacement System represents Integra’s commitment to further advance ankle arthroplasty solutions,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Many of our surgeons have expressed their excitement for the XT system and our approach for ankle revision surgery. With this addition to our ankle reconstruction portfolio, Integra now offers comprehensive care for end-stage ankle arthritis patients.”

The Integra XT Revision Total Ankle Replacement System was developed in partnership with five world leading foot and ankle surgeons – Dr. Michel Bonnin, (Lyon, France), Dr. Chris Coetzee (Eagan, Minnesota), Dr. Jean Alain Colombier (Toulouse, France), Thierry Judet, PhD (Paris, France), and Dr. Mark Myerson (Baltimore, Maryland).  It is available in the U.S. through Integra’s Extremity Orthopedics sales team.

About Integra XT Revision Total Ankle Replacement System
Integra XT is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.  Components are intended for cemented use only.

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™^, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Sravan Emany
(609) 936-2488
sravan.emany@integralife.com

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

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

ROSEMONT, Ill., Nov. 16, 2018 /PRNewswire/ — A new review article published in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) finds arthroscopic (joint replacement or reconstruction) management could be a promising option for young, active patients diagnosed with GHOA.

Primary glenohumeral osteoarthritis (GHOA) is a common type of painful and debilitating shoulder osteoarthritis (OA). Shoulder OA leads to upper body dysfunction in over 20 million Americans. People with GHOA may have trouble throwing, swimming and lifting their arms to do everyday tasks. They often have pain centered in the back of their shoulder. As it progresses, shoulder arthritis pain may interrupt sleep. This condition can be especially frustrating for younger, active patients.

“Total shoulder replacement is not ideal for young, high-demand patients with GHOA,” explains Peter J. Millett, MD, lead author of the study and orthopaedic surgeon at the Steadman Clinic. “Instead patients under 50 years old or select active patients up to age 65 with advanced GHOA who haven’t experienced adequate relief from nonsurgical treatment may experience the greatest benefit from arthroscopic management.”

Over the last 15 years, Dr. Millett has been working on an arthroscopic approach to treat GHOA that preserves the shoulder joint, decreases pain and improves function. This approach, the Comprehensive Arthroscopic Management (CAM) procedure, is also now being successfully utilized by other orthopaedic shoulder specialists for some patients to treat shoulder osteoarthritis.

Outcomes for patients with advanced symptomatic GHOA who underwent CAM procedures include:

• Significantly improved ability to complete daily activities and reduced pain and instability as reported by both patients and doctors (known as the American Shoulder and Elbow Surgeons Shoulder Score (ASES));
• Significant rates of preventing total shoulder arthroplasty (TSA) at one, two, three and five years following CAM procedures; and,
• Median patient satisfaction rate of nine out of 10 five years after CAM procedures among patients who did not need TSA.

Osteoarthritis is the most frequent cause of disability in the United States. Cartilage breaks down, and the body’s healing process can ruin the smooth joint surfaces needed for typical movement. Related inflammation also limits motion. Doctors have multiple surgical and non-surgical treatment options for osteoarthritis. Physical therapy, home exercise, cortisone injections, and anti-inflammatory medications such as ibuprofen may offer relief for osteoarthritis, but the scientific literature supporting these approaches is limited. Despite this, Dr. Millet notes that most doctors will try one or more of these methods before suggesting surgery.

If nonsurgical efforts fail, removing damaged cartilage or bone (debridement) or arthroplasty are potential next steps. However, each of these approaches have potential downsides, including long recovery times, surgical risks and acceleration of the arthritis with more pain, stiffness and dysfunction. With arthroplasty, additional risks related to the artificial joint may include pain, dysfunction and wearing out of implants over time.

In search of a solution to address these shortcomings, orthopaedic surgeons have identified new combinations of treatments that preserve joints and delay or avoid arthroplasty. Dr. Millet and his colleagues combined new and existing procedures to treat this specific arthritis.

“The CAM procedure is a minimally invasive surgery that removes mechanical irritants from the joint, reshapes the humerus to make it round again and also to decrease any impingement on the adjacent nerves,” says Dr. Millett. “The overall goal is to achieve a synergistic benefit with pain relief and functional restoration, without burning bridges for future surgeries, all while delaying joint replacement or perhaps even avoiding it altogether.”

Advantages of arthroscopic management as compared to total shoulder arthroplasty include delaying or avoiding arthroplasty, preserving the joint, and preserving future treatment options. Disadvantages of CAM include that the procedures are technically demanding, long-term outcomes remain unknown, and that there is no guarantee a patient will not need arthroplasty in the future.

“The human and economic costs of shoulder arthritis are substantial and conventional treatment has significant shortcomings. This new, more tailored approach is potentially good news for GHOA sufferers. “Long-term data of patients who have undergone the CAM procedure show promising, but not perfect, results,” Dr. Millett concludes.

The full study is available at: https://bit.ly/2DdneyI
More information about arthritis of the shoulder is at OrthoInfo
More information about the AAOS and JAAOS
Follow the AAOS on Facebook, Twitter and Instagram
Follow the conversation about JAAOS on Twitter

Disclosures
From the Steadman Philippon Research Institute (Dr. Millett and Dr. Fritz), and the Steadman Clinic, Steadman Philippon Research Institute (Dr. Frangiamore and Dr. Mannava), Vail, CO. Dr. Millett or an immediate family member has received royalties from Arthrex and MedBridge; serves as a paid consultant to Arthrex; has stock or stock options held in Game Ready and VuMedi; and has received research or institutional support from Arthrex, Össur, Siemens, and Smith & Nephew. Dr. Fritz or an immediate family member has received research or institutional support from Arthrex, Össur, Smith & Nephew, and Vail Valley Medical Center. Dr. Mannava or an immediate family member serves as a board member, owner, officer, or committee member of the Arthroscopy Association of North America. Neither Dr. Frangiamore nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article. JAAOS – Journal of the American Academy of Orthopaedic Surgeons: November 1, 2018 – Volume 26 – Issue 21 – p 745–752
doi: 10.5435/JAAOS-D-17-00214

SOURCE American Academy of Orthopaedic Surgeons

Related Links

http://www.aaos.org

MEMPHIS, Tenn., Nov. 16, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN,NYSE: SNN), the global medical technology business, presented a number of compelling clinical outcomes around its flagship JOURNEY II BCS knee earlier this month at the American Association of Hip and Knee Surgeons (AAHKS). The announcement follows more than a dozen publications during the past year from various authors around the globe.^1-14

Dave, would you please give us a brief overview of your Orthopedic career and how you got started in the business?

Immediately following my graduation from the Business School at Arizona State University I went to work for American Hospital Supply Corporation. As I progressed through my career with AHSC, they provided excellent training in Sales, plus Sales and General Management This foundation prepared me for my subsequent career in Orthopedics,

My Orthopedic career began in 1982. I have enjoyed the privilege of being a part of four startup/early-stage companies, a global contract manufacturer for Orthopedics and Spine, and some of the major joint companies. My responsibilities have ranged from Sales and Product Management, Senior Sales & Marketing roles, and General Management. They include running the US business for a European based multinational orthopedic company, President of a Digital Imaging company focused on Orthopedic practices, and Global Sales and Customer Satisfaction Leadership for the contract manufacturing division of a Swedish conglomerate who supplied implants and instrumentation to major Orthopedic and Spine companies. Early in my orthopedic career I realized my passion was for technology-based orthopedic, early-stage companies.

My first technology based startup was Intermedics Orthopedics where we introduced a new titanium mesh ingrowth surface to orthopedics. The next endeavor was Orthologic, a bone growth stimulation company which possessed a unique and very effective waveform for the healing of delayed and non-union fractures. As Vice President of Sales & Marketing we grew the company from $0 to $30 million in three years and subsequently acquired Sutter Biomedical. I also served as the Vice President of Sales & Marketing at DonJoy. From there I was recruited by Aesculap Orthopedics to run their U.S. business. Aesculap pioneered Computerized Surgical Navigation and introduced it to America. They also introduced the first Advanced Surface Technology coated knee for patients who are allergic to Cobalt, Chrome, and Nickel. Prior to coming to Myoscience, I spent five years as the West Area Vice President for Biomet Orthopedics with responsibility over Joint Reconstruction, Trauma, Sports Medicine and Biologics. I currently serve as the Executive Vice President, Commercialization for Myoscience.

There is no question the technology Myoscience has introduced is the most exciting I have experienced in my 36 year orthopedic career.

Can you share some of the back story on Myoscience as well as a general overview of where things stand today?

Myoscience, founded in 2005, is a private-equity funded medical technology company based in the Silicon Valley. Its proprietary technology, the iovera° system, was developed as a nontoxic alternative to Botox and initially marketed in Europe.

In 2013, the iovera system was cleared by the FDA for treating peripheral nerves with cryoanalgesia to block pain. The iovera° therapy blocks pain by cryoneurolysis, which is a localized disruption of the signal-carrying members of a nerve. This is referred to as cryoanalgesia – pain relief by applying extreme cold. Physicians explain this treatment to their patients as “freezing of nerves”.

Robust, level 1 clinical studies have found the iovera therapy to be effective as:

A non-opioid nerve block, the effects of which are immediate and long-lasting for treating chronic and perioperative pain.

Since 2016, Myoscience has focused its commercialization efforts on treating chronic knee pain due to osteoarthritis and acute knee pain after total knee arthroplasty. These well-defined market segments help Myoscience establish its iovera technology as a pain management modality of choice, especially to address the opioid crisis the country in currently facing.

Can you explain a high level overview of how the technology works?

The iovera system uses centuries-old, well-established principles of cryoanalgesia. The advantage of using nitrous oxide as the cryogen is it limits the temperature range (-20C to -88C) of cold applied to the target nerve(s). This ensures that the lysis of the nerve is within the 2nd degree of nerve disruption per Sunderland’s classification, which renders this to be reversible.

The therapy is delivered through a compact, cordless and hand-held device. Pressurized liquid nitrous oxide is delivered into closed-end needles, where it is allowed to expand to gas. The phase change produces -88C at the tips of the needles. Moisture from the surrounding tissue freezes to form a small tic-tac sized ice ball at the distal end of these needles. This is sufficient to cause the desired selective lysis of the targeted nerve.

The nitrous oxide gas is vented out through the hand-held device. Therefore, no drug or chemical is delivered into the body.

There is one important distinction – cryoneurolysis by the iovera system should not be confused with cryoablation. Cryoablation is a complete and permanent damage and removal of tissue, most commonly associated with Heat Radio Frequency treatments. The effect of cryoneurolysis, on the other hand, is transient and reversible.

What is the “Why” behind the iovera system?

The opioid crisis in our country is not expected to end any time soon. More than 15% of patients continue to depend on opioids six months after TKA surgery and 40% of patients who use opioids before TKA continue to depend on these drugs several months after surgery.

Physicians and surgeons are trying to use several modalities to limit the dependence on opioids. The iovera therapy has been identified as one of those modalities.

The significant advantage of the iovera therapy over all other modalities is it is drug-free, very localized and non-systemic. It takes a physician or a PA or NP less than 30 minutes to administer it. The provider receives positive confirmation of the treatment because the iovera therapy is administered while the patient is awake.

Where would we expect to see the iovera device being used in the market place?

The safety and efficacy of the iovera technology has been well-established via robust, randomized clinical studies, especially for treating knee pain. Myoscience is currently completing another study on the knee at the Campbell Clinic in Memphis, Tennessee. The results from this study are not only encouraging, but further confirm what has already been observed. The early results were presented at a symposium during the recent AAHKS Meeting. The study results have been selected for a podium presentation by William Mihalko, MD, the Principal Investigator, at the March 2019 American Academy of Orthopedic Surgeons Meeting.

We are currently enrolling patients in a study to establish the iovera therapy’s efficacy in treating patients who undergo ACL repair/reconstruction surgery. Additionally, we plan to expand the application of the iovera therapy to treat shoulder pain and the all-too-prevalent low back pain.

Any closing thoughts or remarks as we wrap up the interview?

The iovera therapy is intended for preventing opioid addiction. The federal government and several state governments are focused on fighting the crisis after the patient is addicted to opioids. Our objective is to prevent the addiction; not fight it after the fact.

Surgeons are beginning to refuse TKA for patients if they don’t receive the iovera therapy. This is a profound statement, especially from the thought leaders in the orthopedic industry. Several surgeons have referred to technology as a “game changer.”

I appreciate the contributions of Jessica Preciado, PhD, our Director of Clinical Research & Principal Scientist and Kris Kumar, our Director, Marketing and Product Management to this article.

Myoscience’s journey has just begun. We foresee the iovera therapy as the pain management modality of choice for treating the pain and symptoms of several diseases in the coming years.

Dave, we really appreciate your time today. Congratulations on all of the success thus far and we look forward to seeing what’s in store for you and the entire team at Myoscience.

SPOKANE, Wash., Nov. 13, 2018 /PRNewswire/ — Dr. David F. Scott, a leading orthopedic surgeon and researcher, is exploring new, innovative knee implant designs and surgical techniques made for custom fit total knee replacements.

The basis for this improved knee replacement performance is an anatomical approach, whereby an implant is placed in the native joint line of a patient’s knee using specific anatomic landmarks around the knee to guide the orientation of the prosthetic components in an attempt to restore the joint to its pre-arthritic position and function. This differs from the more widely used, traditional method where total knee replacements are performed with a mechanical alignment that places implants in an average position for all patients, regardless of their individual anatomy.

Dr. Scott already employs this anatomical approach in his surgical technique, a variation on a technique known as Kinematic Alignment (KA), a surgical method made popular by Dr. Stephen Howell in 2005, and has seen the benefits it provides to his patients, including improved knee function and overall patient satisfaction.

Now, Dr. Scott is building on and advancing the work done by himself, Dr. Howell, and others by helping perfect implants specifically designed for this technique — something that has the potential to shape the future of total joint replacement procedures.

While only a small fraction of surgeons use an anatomical approach for knee replacements, the technique is gaining more interest due to exposure in scientific publications and at joint replacement meetings, symposia, and educational events, of which Dr. Scott actively participates.

Dr. Scott and Dr. Howell have worked to vocalize and teach the merits of this approach through a series of learning centers, where didactic lectures are followed by cadaver surgeries. Additionally, Dr. Scott is designing instruments to aid and perform the surgical technique, as well as advising manufacturers of orthopaedic devices on the design of research protocols to compare KA to the the traditional mechanical alignment technique with the hope of providing more concrete evidence of its merits.

“Anecdotally, the single most important finding of the research surrounding the anatomical approach is that it’s possible to improve significantly the clinical outcomes after total knee arthroplasty (TKA),” says Dr. Scott. “My research shows that an anatomic approach can work very well — that a more anatomic knee implant design, coupled with an anatomic approach to the surgical procedure itself, produces the best results ever seen with TKA.”

Although more longer-term studies are needed to prove further these already stellar results, Dr. Scott feels confident that this approach is the future of knee replacement.

“This custom alignment process is where the future of knee replacements is going. Average alignments are the old school method which I believe will be phased out completely over time,” says Dr. Scott. “The research is already out there with more being done to prove the effectiveness of custom alignments every day, and we’re really happy to be leading this work.”

Dr. Scott has published and presented research extensively in the orthopaedic field, and, specifically, on the benefits of the anatomical approach to knee replacement and implant design. He recently published a paper in the May 2018 issue of the “Journal of Arthroplasty” titled “Prospective Randomized Comparison of Posterior-Stabilized Versus Condylar-Stabilized Total Knee Arthroplasty: Final Report of a Five-Year Study”; in an ongoing study titled “Medial-Pivot, Cruciate- Substituting, Post-Market Multicenter Outcomes Study,” a multi-center study comparing the results of knees implanted with the KA approach versus the results from other surgeons using the mechanical alignment approach; and in a podium presentation titled “Patient Satisfaction and Clinical Outcomes Are Better With a Medial-Stabilized Implant vs. a Posterior-Stabilized Implant” presented to the International Society for Technology in Arthroplasty in London, Englandin October of 2018.

For more of Dr. Scott’s research, visit the research section on the OSC website (https://orthospecialtyclinic.com/our-research).

About Dr. David F. Scott
Dr. Scott completed his orthopaedic residency in New York City at the Hospital for Joint Diseases. He received fellowship training in adult reconstruction at the University of Utah, where he was an adjunct assistant professor at the School of Medicine for over 5 years. He is currently a clinical instructor at the UW School of Medicine, and specializes in arthritis surgery with an emphasis on joint replacement. David F. Scott, MD is an active member of the American Association of Hip and Knee Surgeons. His practice, Orthopaedic Specialty Clinic, is based in Spokane, Washington. For more information about OSC, visit the website (https://orthospecialtyclinic.com).

Media Contact:
Geneva Randall 
204564@email4pr.com 
509-690-6085

SOURCE Dr. David F. Scott

Related Links

https://orthospecialtyclinic.com/our-research

November 13, 2018

YARDLEY, Penn., Nov. 12, 2018 /PRNewswire/ — Today marked the launch of the Reduce Revisions Initiative (www.reducerevisions.org), a program focused on supporting orthopedic professionals with the goal of measurably improving outcomes of total joint arthroplasty (TJA).

Total Joint Arthroplasty can dramatically improve lives by restoring mobility, reducing pain, and promoting a return to normal activities. Most of these procedures include Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). During one year in the U.S. alone, orthopedic surgeons perform more than 1 million TKA and THA procedures. According to the 2018 published estimates on total joint replacement from the American Academy of Orthopedic Surgeons, this number is expected to nearly double by 2030. Though very successful, joint replacement occasionally fails requiring revision. In the US over 100,000 patients undergo revision knee and hip replacement each year, and that number that is also expected to grow rapidly in the coming years.

“One mode of failure of joint replacement is infection. Because of the sheer number of joint replacements we do and better diagnostic modalities, the number of infected joint replacements are also likely to rise in the coming years. Infection of a prosthetic joint is a major problem for both the patient and the healthcare” shared Dr. Javad Parvizi, Professor of Orthopedic Surgery at Rothman Institute in Philadelphia and chair of the Reduce Revisions editorial board. “It’s time for us to face this issue head on, and I’m excited about the potential for the Reduce Revisions Initiative to be part of the solution by promoting best practices and sharing innovative developments in total joint replacement.”

In order to make a meaningful contribution to total joint arthroplasty patient care, Reduce Revisions will create communication channels focused on sharing information with total joint surgeons, nurses, administrators, and other key healthcare professionals in the patient care continuum. The Initiative’s Editorial Board has identified several key areas for education:

• Infection prevention & management
• Fixation optimization
• Patient involvement in preventing revision surgery
• New frontiers in TJA
• Improving economics

Reduce Revisions also will work to accelerate research around total joint arthroplasty quality improvement and complications management. A five-member editorial board, comprised of distinguished orthopedic researchers and surgeons, is now developing forums and events that foster collaboration and sharing of surgeons’ experiences, as well as exploring ways to make ongoing learning opportunities easily accessible. Ultimately, Reduce Revisions will measure its success by the outcomes of primary total joint replacement surgery and the shift in need for revision surgery.

About Reduce Revisions
Reduce Revisions is focused on supporting orthopedic professionals through education and collaboration, with the goal of improving outcomes of total joint arthroplasty, thus reducing the need for revision surgery. The initiative is sponsored by Heraeus Medical, the inventor and exclusive manufacturer of PALACOS^® bone cement products. Learn more and join the community at www.ReduceRevisions.org.

Reduce Revisions Editorial Board
Chair: Javad Parvizi, MD, FRCS
Members: Antonia Chen, MD, MBA; Carlos Higuera-Rueda, MD; Bryan Springer, MD; Michael Kheir, MD; Thorsten Gehrke, MD

Contact:
Christine Horton
DevicePharm, Inc
Christineh@devicepharm.com
952-873-9030

SOURCE Reduce Revisions

Related Links

https://www.reducerevisions.org

November 12, 2018