News – Page 264 – Selby Spine

by Tyler Koslow | Nov 2, 2016

When it comes to utilizing 3D printing technology to produce medical devices and tools, there is usually a comprehensive trial that these printed materials must undergo before they can be applied in the healthcare sector. These pre-clinical studies help to unearth the benefits and disadvantages of these potential medical solutions, comparing them to other biocompatible materials that are commonly used in similar applications. The medial technology company Stryker is one of the pioneers of using 3D printing technology to enhance the production of medical devices and implants.

After announcing plans to start construction on a multimillion-dollar 3D printing manufacturing facility earlier this year, Stryker went on to develop their 3D printed Tritanium Posterior Lumbar (PL) Cage Spinal Implant, which was debuted at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting back in May. Last week, the Spine division of the medical technology company announced the completion of a pre-clinical study for this Tritanium PL Interbody Cage.

The results of the study compare their highly porous titanium alloy with the biomechanical, radiographic, and histological performance of commonly used implants with different surface technologies in an ovine lumbar interbody fusion model. The materials involved in the comparative study include traditional PEEK cages and plasma-sprayed titanium-coated PEEK cages. Using their proprietary Tritanium Technology, Stryker was able to produce a material with porous structures that resembles spongy bone tissue.

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By: Glenn Snyder – November 17, 2016

Today, the health care industry appears to be facing an inherent tension. On one side, many consumers – both as patients and caregivers – are demanding new, more efficient technology solutions. On the other side, medtech companies are still trying to figure out when and how to innovate under the new value proposition. While the incentives around value-based care are emerging, the health care industry is still trying to figure out its innovation strategies. This uncertainty has left many medtech companies assessing how best to invest in innovation while balancing the need to generate stakeholder value.

The growing aging population, higher prevalence of obesity and chronic disease, greater preference to age in the home, and increasing interest from caregivers are driving consumer demand for products and technologies. Deloitte’s 2016 Survey of US Health Care Consumers reveals that many consumers (seven in 10 surveyed) are interested in health care Internet of Things (IoT) technologies. Additionally, 82 percent of respondents reported that they would prefer to age-in-place rather than move to a care facility or in with a family member.

Despite personal hesitancy in using certain technologies, our survey found that more consumers say they are likely to use sensor technology, telemedicine, and remote monitoring technology when caring for others.

At the same time, health care reform and the move toward value-based care are fundamentally changing the system and how it pays for services and products. New payment models – shared savings, bundled payments, shared risk, and global capitation – are emerging. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is moving the industry in this direction even more rapidly than before – not only impacting physicians, but most health systems also.

Under new value-based care payment models, medtech companies have a new opportunity for reimbursement. Physicians may be willing to spend more on technologies and devices that can help them succeed under risk-based models – which will provide bonuses for physicians tied to improved patient outcomes.

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OAKLAND, N.J., Nov. 22, 2016 /PRNewswire/ — Collagen Matrix, Inc., which advances the science of tissue repair and regeneration by designing, developing and manufacturing collagen and mineral based medical devices that support the body’s natural ability to regenerate, announced today the appointment of Oystein Valberg as its Chief Financial Officer. Mr. Valberg will oversee finance and administration as well as the human resources team.

Mr. Valberg has more than 20 years of progressive senior corporate finance leadership and business development experience, including 17 years with Medtronic Plc where he earned a reputation as a strong, “hands on” organizational leader.

Most recently, he served as CFO and Vice President of Finance, Strategy and Business Development for Medtronic’s Surgical Technology business unit. His valuable experience working with Medtronic also included responsibilities in Corporate Development, Treasury and Investor Relations.

Prior to Mr. Valberg’s tenure at Medtronic, he served as an Analyst with US Bankcorp, and as an Auditor for Grant Thornton where he earned his CPA. Mr. Valberg earned a bachelor’s degree and a master’s degree in business administration from the Carlson School of Management in Minneapolis.

Bart Doedens, Collagen Matrix CEO, commented: “We are excited and pleased to welcome Oystein to our executive team. As we continue to build our framework for growth, Oystein will be one of the contributors to our success. His background and experience are an excellent fit and will serve us well.”

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Neurosurgical, Spine, Orthopaedic and Nerve Repair Surgery. More information about Collagen Matrix can be found at www.collagenmatrix.com.

Contact:
Margo Lane
201-405-1477
mlane@collagenmatrix.com

Photo – http://photos.prnewswire.com/prnh/20161122/442064

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/collagen-matrix-inc-names-oystein-valberg-as-chief-financial-officer-300367468.html

IANS | Nov 24, 2016

Spine Navigation Technology – an image-based medical technology – can be the best way to perform delicate and complex spinal surgeries, said doctors on Wednesday.

According to them, the biggest advantage of the Spine Navigation Technology is that doctors are able to operate with better visualisation and more accuracy than ever before.

“The image-based technology used in spinal surgery utilises scans of the patient’s anatomy and instruments that are tracked by the Navigation System’s camera. The specialised software creates a virtual, 3-D model of the patient’s spine, essentially a digital roadmap or blueprint to help guide the surgeon,” said Arvind Kulkarni, Head of Spine Scoliosis and Disc Replacement Centre at Bombay Hospital.

Adding further, he said: “The spine surgeon can use this model to plan the details of the surgery including the number, size and location of implants.”

He said that the new technology used during complex cases enables faster, precise and less invasive spinal procedures in a reduced radiation environment.

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CHICAGO, ILLINOIS (PRWEB) NOVEMBER 25, 2016

This study is a prospective, open label, non-randomized study to be conducted at the Weil Foot-Ankle and Orthopedic Institute. Twenty patients meeting the study inclusion and exclusion criteria and categorized as Osteoarthritis Grade 2 to Grade 3 by the K-L scale will be enrolled.

Dr. Sheinkop will be injecting concentrated bone marrow-derived stem cells and growth factors into the knee joint, the latter consisting of the intraarticular space between the femur and tibia, as well as into the tibia bone adjacent to the joint. Patients will be followed for one year, and they will be scheduled for periodic follow-up visits over the entire year to measure improvements in pain relief and function.

Current options for treating patients with knee osteoarthritis have been limited to pain medication, steroids, hyaluronic acid injections, physical therapy, chiropractic care, or any combination thereof; ultimately, a knee replacement. While these options may provide temporary symptom relief, they do not provide a long-lasting healing effect for the osteoarthritic knee nor is there a possibility of avoiding a major surgical procedure. Bone marrow-derived stem cells and growth factors offer regenerative potential when injected both into the joint and into the bone supporting the joint. Studies have shown that concentrated bone marrow-derived stem cells and growth factors have the potential to slow the degenerative process and, at times, reverse it, and they may eliminate or significantly delay the need for surgical intervention.

The importance of this study is to, for the first time, scientifically document what has been suggested by an emerging awareness about arthritis of joints, namely the articular cartilage of the joint, which might be better dealt with by considering the adjacent bony elements along with the soft tissue degradation. The role of mesenchymal stem cells and growth factors residing within the adjacent bone marrow compartments have been highlighted through the work of Dr. Philippe Hernigou (Chief, Department of Orthopaedic Surgery, Henri Mondor Hospital, University of Paris, France). The use of a patient’s own bone marrow concentrate to treat both the soft tissue, cartilage, and subchondral bone marrow could play a significant role in improving outcomes in osteoarthritic knees.

For questions about the clinical study, please contact Andrea Leon of Weil Foot-Ankle and Orthopedic Institute at aleon(at)weil4feet(dot)com or call 312-475-1893.

Dr. Mitchell B. Sheinkop is a Board-Certified Orthopedic Surgeon, former director of the joint replacement program and Professor Emeritus at Rush University Medical Center. He is a leading authority on the treatment of patients with complex hip and knee disorders, and he is well known for his pioneering use of computer-assisted navigation, minimally-invasive technologies, and hip resurfacing techniques. During his 37-year joint replacement surgical career, the integration of his clinical practice with his research played a role in the emergence of evidence-based orthopedics. Dr. Sheinkop retired from his active surgical practice six years ago to assume a pioneering role in the new subspecialty of Cellular Orthopedics. Over the past four and a half years, he has performed over 500 Interventional Orthopedic procedures.

LA MIRADA, CA (PRWEB) NOVEMBER 24, 2016

Healthpointe is pleased to announce the addition of Dr. Hailey Dizay, D.O., to the orthopedic, surgical and sports medicine team. Dr. Dizay is fully trained in treating patients suffering from fractures, swelling, bruising, strains, sprains, and sports related injuries along with pain in the muscles, tendons and joints. She also specializes in providing treatment for patients with limited range of motion, such as an inability to straighten the back, fully raise the arm, and other movements.

Dr. Hailey Dizay is a board certified Orthopedic Surgeon who specializes in arthroscopic and minimally invasive reconstructive surgery, shoulder and knee disorders and sports medicine. She received her Bachelor of Science degree with honors from the University of California, San Diego, and then received her medical degree from Touro University Nevada. She completed her Orthopedic Surgery residency through Michigan State University at Metro Health Hospital. She completed further orthopedic subspecialty training through an Orthopedic Sports Medicine and Arthroscopy fellowship at the Sports Clinic in Laguna Hills, California.

Dr. Dizay also has had extensive experience caring for athletes throughout her medical career. She has been a team physician for the University of California Irvine, The Los Angeles Angels of Anaheim, Laguna Hills High School, Michigan State Athletic games, Rockford High School, and several Mixed Martial Arts, kickboxing, boxing and running events.

Healthpointe’s orthopedic specialists perform surgical procedures as a last resort for complicated musculoskeletal issues. However, our orthopedists will focus on delaying surgery as much as possible in favor of less invasive treatments, such as medication and physical therapy. If these treatments are exhausted and no longer provide any relief for pain and other symptoms, surgery may then be recommend.

For more information on Healthpointe’s orthopedics department, or to learn more about Dr. Dizay, please schedule an appointment through http://www.Healthpointe.net or call (800) 856-2663.

About Healthpointe:

Healthpointe is a leading multidisciplinary healthcare organization offering a full range of medical services in practice locations throughout Southern California (Los Angeles County, Orange County, San Bernardino County, and Riverside County). Healthpointe has locations situated in over 10 cities in Southern California including Garden Grove, which is conveniently located by Stanton, Santa Ana, Westminster, Orange, Fountain Valley, Cypress and Anaheim. As a highly regarded musculoskeletal group, we have a personal investment in the highest level of service, and we are proud of our record of excellence over the last four decades with private patients, injured workers, urgent care, personal injuries, and professional and non-professional athletes. Leading our organization is a dynamic team of healthcare professionals who continually strive to be at the forefront of medical innovation and healthcare service delivery. For more information, a complete list of services, and Healthpointe locations, visit http://www.Healthpointe.net.

Posted in Regulatory and Compliance by MDDI staff on November 21, 2016

The FDA has released a final guidance on Medical Device Reporting for Manufacturers. This follows the corresponding draft guidance of July 2013 and replaces the guidance of March 1977, which is no longer available on FDA’s website. That guidance was ambiguous with regard to the reporting of non-injurious malfunctions caused by user error. Among various revisions from the 2013 draft is the treatment of user error, which the guidance also calls “use error.”

To many, these terms are not interchangeable since user error seems to denote clear fault (the user) while use error identifies what happened but leaves the cause open. For instance, the error might have been caused or facilitated by inadequate labeling or bad design. The term “use error” was introduced in MD+DI in 1995 and has since been widely adopted.

FDA notes with regard to use errors that “such errors often reflect problems with device labeling, the user interface, or other aspects of device design.” Further, FDA states that it “believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device.” It then goes on to say that such errors related to deaths and serious injuries are to be reported, as has been the case. However, use errors associated with malfunctions that did not result in death or serious injury no longer have to be reported, according to the new guidance.

This is a change from the draft and may reflect feedback from industry participants who did not want to have to report use errors that weren’t associated with deaths or serious injuries. It may also be that FDA decided they didn’t want to deal with such reports. Unlike the preamble to rules and regulations, which are sometimes cited as agency policy and give a—more or less—detailed analysis of why an agency made the decisions it did, guidance documents are issued without such analysis being publicly reported.

So much for transparency. In contrast, the 1995 MDR Final Rule included 20 pages of notes and comments in the three-column Federal Register format.

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By Nathan Hurst, November 22, 2016

Injury is a sad fact of military service, especially in wartime. According to a study performed by scientists at the Uniformed Services University of the Health Sciences, by far the most frequent is soft tissue injuries to skin, fat and muscle.

Of these, muscle damage is particularly difficult to heal. Beyond a certain size—about one cubic centimeter—the body simply cannot do it. As a result, people experiencing this kind of trauma, called volumetric muscle loss, lose function of the muscle, and experience deformation, scar tissue or contracted muscles.

According to a study from 2015 in the Journal of Rehabilitation Research and Development (a peer-reviewed publication put out by the Department of Veterans Affairs), volumetric muscle loss is typically permanent.

“The current primary standard of care for [volumetric muscle loss] injuries is physical rehabilitation,” says Benjamin Corona, lead author of the study. “The documented cases available do not indicate significant functional recovery unless energy returning orthoses [braces or other devices] are used. Physical rehabilitation alone will not promote regeneration of the lost tissue.”

Corona and his team of researchers looked at the records of more than 500 service members who were discharged from the military due to injuries between 2001 and 2007. They found that most broken bones sustained in combat result in open wounds, and that while the bone can often be repaired, the muscle is left damaged. Service members who sustained broken bones are often disqualified from service not because of the break, but because of disability due to the soft-tissue wound.

“Despite a tremendous amount of attention given to bone healing after type III open tibia fracture, based on the current findings it is appropriate to conclude that soft-tissue complications make the majority contribution to disability of salvaged limbs,” the authors wrote. “The development of therapies addressing [volumetric muscle loss] has the potential to fill a significant void in orthopedic care.”

Historically, the best course of treatment was to use a flap of muscle, either from a different part of the body or rotated from a connected muscle, to cover the wound. This helps to heal, but cannot provide the normal use of an uninjured muscle, and so the limb where the injury occurred is often permanently disabled.

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By Lucette Lagnado, Nov. 16, 2016

Organ-transplant surgeons have skills most of us can only dream about. One, concentrating for hours straight, is something we can aspire to.

Transplanting a liver can take eight to 10 hours. Surgeons are on their feet the whole time, hunched over the operating table. They minimize breaks for the bathroom or refreshments. And they need frequently to be on call, ready to perform an operation whenever an organ becomes available.

Members of the abdominal-organ transplant team at Montefiore Einstein Center for Transplantation, in Bronx, N.Y., have carefully honed strategies they use inside the operating room, and away from the job, to push through long surgical procedures. Some techniques are simple, like wearing comfortable shoes. Others stem from an awareness that implanting a new organ can save a patient’s life.

“You get into a zone when you are operating,” says Milan Kinkhabwala, chief of transplant surgery at the center, part of the Montefiore Health System. “Your mind is so focused on what you are doing, you are not aware of time.”

Transplant surgeons, whose work includes stitching minuscule blood vessels together, minimize their distractions. No one checks cellphones in the operating room during surgery. The surgeons often wear loupes mounted on eye glasses to magnify their work, which limits their field of vision to a few inches.

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NOVEMBER 22, 2016 BY BRAD PERRIELLO

Medtronic (NYSE:MDT) shares dropped in pre-market trading today after the world’s largest medical device company missed Wall Street’s expectations with its fiscal 2nd-quarter sales and lowered its outlook for the rest of the year.

Fridley, Minn.-based Medtronic posted profits of $1.12 billion, or 80¢ per share, on sales of $7.35 billion for the 3 months ended Oct. 28, for bottom-line growth of 114.4% on sales growth of 4.1% compared with Q2 2015.

Adjusted to exclude 1-time items, earnings per share were $1.18, 6¢ ahead of the forecast on The Street. But analysts there were looking for sales of $7.46 billion; investors reacted by pushing MDT shares down -7.3% to $74.70 in pre-market activity today.

“Q2 revenue was disappointing and did not meet our expectations. We faced issues that affected our growth, including slower-than-expected revenue as we await new product introductions, particularly in CVG and Diabetes,” chairman & CEO Omar Ishrak said in prepared remarks. “Despite this revenue shortfall, we produced a strong improvement in operating margins and double digit constant currency earnings per share growth.”

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Current Issues in Spine

Stryker Conducts Successful Pre-Clinical Trial on 3D Printed Tritanium PL Interbody Cage

The tipping point for medtech: Consumer demands, innovation, and reimbursement

By: Glenn Snyder – November 17, 2016

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Spine Navigation Technology can ease surgery complications: Doctors

Now Enrolling Patients for a Research Study Examining the Feasibility of Treating Osteoarthritic Knee with Autologous Bone Marrow Concentrate

Orthopedic Surgeon and Sports Medicine Specialist Joins Healthpointe in Garden Grove

Use Error Takes a Hit in New MDR Guidance

How Artificial Muscles Could Transform the Lives of Some Military Veterans

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