BOCA RATON, Fla., Aug. 9, 2017 /PRNewswire/ — Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announces the initiation of a Multi-Center Prospective Study in Primary Total Hip Arthroplasty for its lead hip replacement system, the HRS.  Total hip arthroplasty is commonly referred to as total hip replacement.

The objective of the clinical trial is to evaluate the effectiveness and safety of the HRS hip replacement system in 100 – 120 patients receiving a total hip arthroplasty (THA).  Effectiveness will be evaluated using clinical, radiologic, radiostereometric and patient-reported outcomes.  Safety will be assessed through the collection of device-related adverse events.  Patient quality of life metrics will also be closely monitored.

“The HRS is a unique hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty,” said George Diamantoni, Hip Innovation Technology’s Co-Founder and Chief Executive Officer. “We look forward to confirming potential differentiating clinical benefits including hip stability at extended ranges of motion, reduced risk of device dislocation and greater latitude for placement of hip components relative to the current designs.”

The company has extensively tested the HRS in over 80 standard and unique pre-clinical experiments to assess the product safety and clinical benefits anticipated by the unique system design.

“The bench level data compiled for the HRS is more extensive than any that I have reviewed for currently marketed hip implant systems,” said Thomas Turgeon, MD, Chief Medical Officer of the Orthopaedic Innovation Centre, and Orthopaedic Surgeon at Concordia Joint Replacement Group. “I am impressed with the unique system design.  I look forward to assessing its clinical performance, and am hopeful that many patients will benefit from this novel device.”

Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems.  During the 2015 calendar year, approximately 324,000 surgeries were performed in the U.S. and 50,000 in Canada.

About Hip Innovation Technology, LLC

Headquartered in Boca Raton, Florida, Hip Innovation Technology was formed in 2011 to provide market-leading orthopedic device solutions that advance the quality of life and quality of care for patients.  In partnership with healthcare professionals worldwide, our goal is to identify unmet clinical need, then design, manufacture and ultimately market innovative orthopedic reconstructive and related surgical product solutions.

About the HRS

The HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability at extended ranges of motion and reduce the risk of dislocation.  Like most conventional systems, the HRS consists of a femoral stem, an acetabular cup and a cobalt-chrome ball that articulates within a polyethylene liner.  Unlike other systems, the ball sits on the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which attaches to the femoral stem, instead of the polyethylene liner being attached to the acetabular cup.  Despite this technological difference, the center of rotation of the HRS is similar to a normal physiological hip or a well-positioned Total Hip Arthroplasty.  The advanced HRS implant design may provide greater range of motion in all planes with enhanced hip stability while significantly minimizing the risk of dislocation.  In addition, the HRS may provide minimal postoperative restrictions and reduce the need for currently required durable medical equipment such as abduction pillows, elevated toilet seats and shower chairs.  Importantly, the HRS also provides variability of component placement including higher abduction angles and anteversion of the acetabular cup.  The femoral cup articulates around the acetabular ball and overlaps with the acetabular cup as the hip undergoes flexion-extension, abduction-adduction and internal-external rotation.  This forgiving design compensates for suboptimal component positioning which likely provides benefits such as extended range of motion, hip stability and reduced likelihood of impingement.  Simply stated, the HRS appears to uncouple the relationship between component placement, wear and stability.  The unique implant design of the HRS provides optimal surface area contact between the acetabular ball and femoral cup, which may eliminate edge loading.  Elimination of edge loading may provide benefits that include reduced high-contact stresses, decreased implant wear and uniform wear, which minimizes generation of wear debris and associated concerns related to osteolysis.

For more information, visit www.hipinnovationtechnology.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release may contain 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 Hip Innovation Technology’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.  Hip Innovation Technology disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  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.

Contact:
George Diamantoni, CEO
Hip Innovation Technology
InvestorRelations@HIT-IRH.com  

Media:
Kara Golub
JFK Communications, Inc.
(609) 456-0822
kgolub@jfkhealth.com  

SOURCE Hip Innovation Technology, LLC

Related Links

http://www.hipinnovationtechnology.com

(PR NewsChannel) / August 8, 2017 / CHICAGO

FH Orthopedics, Inc. (FH Inc.), a designer and manufacturer of sports medicine, trauma and joint reconstruction products, announced today the successful first total shoulder arthroplasty using the novel Arrow®Prime cementless glenoid baseplate.  Supported by 14 years of successful clinical history, Arrow®Prime offers surgeons unparalleled intraoperative flexibility, dual-platform interchangeability, and addresses the continuum of indications for shoulder arthroplasty in an efficient, 4-tray instrument system.

The Arrow®Prime was cleared by the FDA in April 2017 and has been implanted successfully in multiple centers across the U.S.

Patrick Noud, MD (Lansing, MI) implanted the first Arrow®Prime cementless glenoid baseplate in the U.S.  “My initial experience was very satisfying.  Relative to traditional cemented polyethylene glenoid implants, the Arrow®Prime anatomic metal-backed glenoid and instrumentation were seamless and efficient, the press-fit of the porous implant impressive, and the procedure was quicker, as no bone cement was required.”

READ THE REST HERE

WARSAW, Ind., Aug. 7, 2017 /PRNewswire/ — DePuy Synthes* has announced an exclusive agreement with Medical Enterprises Distribution, LLC to co-market the ME1000™ Surgical Impactor for use in Total Hip Arthroplasty (THA). The ME1000 is designed to replace the handheld mallet used in THA. The ME1000 delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning. This in turn may lead to more consistent clinical outcomes and favorably impact patient satisfaction.

Because the battery-powered ME1000 automates THA, there is also likely to be less surgeon fatigue and potentially less work-related injuries that can arise from mallet use. A 2016 study published in The Journal of Arthroplasty showed that 66.1% of 183 orthopaedic surgeons who responded to a survey experienced a work-related injury and that 31% of responding surgeons required surgery for their injury.¹ The paper cited the use of repetitive movements with operating instruments and tools as a potential cause for upper limb tendinitis and discussed the need for measures to improve the surgical environment and work ergonomics for orthopaedic surgeons.¹

“In addition to its potential benefits for both patients and orthopaedic surgeons, the ME1000 can be easily integrated into a surgeon’s operational technique and into the hospital’s processes,” said Aaron Villaruz, Global Hip Platform Leader, DePuy Synthes Joint Reconstruction. “We at DePuy Synthes view this technology as a significant advancement as we strive to help our customers meet their goals of improving clinical outcomes, increasing patient satisfaction and managing costs.”

The ME1000 is compatible only with DePuy Synthes hip systems. Adapters are available for anterior and posterior approaches to THA. One of the early users of the technology is Dr. Joel Matta**, a pioneer in the Anterior Approach to Hip Replacement who is affiliated with the Steadman Clinic in Vail, CO.

“I’ve used the ME1000 on more than 100 primary DePuy Synthes hip implants, and my observation is that, compared to a mallet, the ME1000 reduces peak forces while increasing energy per second,” said Dr. Matta. “I have found that the rotational stability of the implants is more easily and consistently achieved, and the risk of fracture potentially reduced. It is also easier for me to make adjustments, and achieve a precise position of the acetabular cup. I also appreciate that the physical effort and resultant fatigue from performing a hip replacement surgery is markedly reduced which benefits my capabilities during a full surgical schedule.”

DePuy Synthes is expected to begin co-marketing the ME1000 with Medical Enterprises Distribution, LLC within the current quarter.

About DePuy Synthes Companies

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

About Medical Enterprises Distribution, LLC

Based in Norcross, GA, Medical Enterprises Distribution, LLC, is a pioneering healthcare technology firm focused on surgical procedure innovation.  For more information, visit http://www.medistribution.com.

ME1000 Photo Courtesy of Medical Enterprises Distribution, LLC

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the ME1000. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors”, its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement because of new information or future events or developments.

¹ Alqahtani S, Alzahrani M, Tanzer M. Adult Reconstructive Surgery: A High-Risk Profession for Work-Related Injuries. The Journal of Arthroplasty 2016; 31(6): 1194-8.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**Consultant to DePuy Synthes Joint Reconstruction with an ownership interest in Medical Enterprises Distribution, LLC.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

The third-party trademarks used herein are the trademarks of their respective owners.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

WARSAW, INDIANA (PRWEB) AUGUST 04, 2017

OrthoPediatrics Corp. is pleased to announce the launch of the PediFrag™ Pediatric Specific Clavicle Plate. This innovative new plate is specifically designed for treating mid-shaft clavicle fractures in young patients. The OP Clavicle Plates are unique due to their pre-contoured shape. This curvature was derived from studying 36 pediatric clavicle skeletons from OrthoPediatrics’ exclusive access to the Hamann-Todd skeletal collection in Cleveland, Ohio.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, is excited to bring another device to the Pediatric Orthopedic market – saying, “We are successfully implementing our strategy of surrounding pediatric surgeons with all the surgical systems they need. The breadth and depth of our Trauma and Deformity Correction portfolio is unmatched and we are continuing to develop new products.”

President and Chief Executive Officer, Mark Throdahl echoed this excitement, adding “The launch of our clavicle plates is one more example of our continued growth. OrthoPediatrics is committed to improving the lives of children with orthopedic conditions through the development of new products and supporting clinical education for pediatric orthopedic surgeons.”

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 20 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 32 countries outside the United States.

HONG KONG (PRWEB) JULY 19, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first KneeAlign® cases completed for total knee arthroplasty (TKA) in Hong Kong. These cases were completed by Hong Kong-based orthopaedic surgeon Professor Kevin K.W. Ho at Prince of Wales Hospital, one of the country’s leading public hospitals, in collaboration with OrthAlign’s local distribution partner Smith & Nephew Hong Kong.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

Professor Ho stated, “KneeAlign is large console navigation in a small, handheld box. The technology is so easy to use and gives me accurate information that I need, all within the sterile field, without all of the hassles and extra costs that large console computer assisted surgery systems require. I was pleased with my first set of cases and will continue using it because I believe it is valuable for my practice in providing the best possible outcomes for my patients.”

“Navigation plays a very important role in Hong Kong’s joint arthroplasty market,” said Priscilla Chan, General Manager of Smith & Nephew Hong Kong & Taiwan. “Surgeons and hospital facilities believe in navigation, but cost and operational inefficiencies have been key barriers in adoption optimization. I believe OrthAlign provides a revolutionary technology that addresses those barriers and will finally give Hong Kong a product that can be accessible by every hospital and surgeon. We look forward to growing the business through our partnership with OrthAlign.”

In a published TKA clinical study by Denis Nam, M.D. (Rush University Medical Center, Chicago, IL), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mean mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).

“Hong Kong’s orthopaedic market may be one of the most fascinating in the world,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “There are so many dynamics in the marketplace, such as public vs. private hospitals, long queues for patients who are on 3-year waiting lists for their total knee arthroplasties, and a strong desire for technology by surgeons. Without question, hospitals and surgeons value navigation technology, and OrthAlign will be the best option for them, not only from a price point, but also in terms of accuracy and operational workflow. As OrthAlign continues to focus on its mission in expanding customer reach, we welcome Hong Kong to the growing OrthAlign family and look forward to working with Smith & Nephew Hong Kong in providing local hospitals, surgeons, and patients our technology.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”