Author: Allison Downey

Exactech Redefines the Status Quo with Equinoxe® Ergo® Instruments for Shoulder Surgery

New Instruments Support Outpatient Surgery and Navigation

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GAINESVILLE, FLA. (Nov. 10, 2021) – Exactech, a developer and producer of innovative implants, instrumentation and smart technologies for joint replacement surgery, announced today the full launch of Equinoxe® Ergo® instrumentation which supports its flagship shoulder system. Ergonomic, ideal for outpatient surgery and compatible with the ExactechGPS® navigation system, the new instrument sets perpetuate the Equinoxe shoulder system’s heritage of design excellence.

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...Surgeons want instrumentation with ease-of-use. The Ergo instruments are interchangeable, which helps cases run smoothly. With Ergo, we have consolidated to just a few trays, which translates to cost savings. It’s positive for the hospital and for my surgical team....
Stephanie Muh, MDHenry Ford Health System
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The Ergo instruments are designed with a focus on ergonomics – to be comfortable in the surgeon’s hands and to offer a secure grip. The modular components are intended for easy assembly and adaptable to the surgeon’s individual preferences. Many of the instruments serve multiple functions which means a more efficient, space-saving experience in the operating room. Equinoxe Ergo instruments represent a 50% reduction in instrument trays, which can decrease the reprocessing cost per case and make them ideal for the outpatient surgery environment.

“Surgeons want instrumentation with ease-of-use. The Ergo instruments are interchangeable, which helps cases run smoothly,” said Stephanie Muh, MD, an orthopaedic surgeon at Henry Ford Health System and Ergo design team member. “With Ergo, we have consolidated to just a few trays, which translates to cost savings. It’s positive for the hospital and for my surgical team.”

According to Exactech’s Senior Vice President of Extremities Chris Roche, “The new Ergo instruments build on two decades of clinical experience with the Equinoxe, the industry’s fastest-growing shoulder. They showcase the innovation and design style that is central to the Equinoxe system’s success – and redefine the status quo in shoulder surgery.”

Another key feature of the new Ergo instruments is their compatibility with ExactechGPS® shoulder navigation. The GPS-compatible Ergo instruments include access to newly designed reamers, drills and other instruments, as well as an updated half-tray assembly – all of which allows for a more efficient workflow.

“Having new, updated instruments that allow surgeons to take full advantage of the ExactechGPS navigation system is a monumental, highly anticipated step forward,” said Scott Trenhaile, MD, orthopaedic surgeon at Ortho Illinois and Ergo design team member. “ExactechGPS is being used in more and more shoulder cases, and the compatible Ergo instruments will make adoption even easier.”

In just five years since its introduction, the ExactechGPS shoulder application is now used in ~40% of Equinoxe shoulder cases performed worldwide. The navigation system’s use is steadily increasing around the globe, including introduction in Brazil last month.

Ergo instruments are available in the U.S. and select regions globally, with expansion to other countries in 2022. Additional instruments, including for augment implantation, are being piloted now.

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About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit staging.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

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Media Contact

Nancy Walsh, APR
Director, Marketing Communications
352-377-1140

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Exactech Co-Founder Gary Miller, PhD, Announces Retirement, Transition to Emeritus Status

Biomedical Engineer and Innovation Leader Served Joint Replacement Company for 36 Years

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GAINESVILLE, Fla. (Oct. 1, 2021) – Exactech, a developer and producer of innovative implants, instrumentation and smart technologies for joint replacement surgery, announced that Co-founder and Executive Vice President of R&D Gary Miller, PhD, is retiring from his current role. He will transition to Emeritus status and serve the company in an advisory role beginning today.

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...“Dr. Miller has been a brilliant, gregarious and inspiring mentor to many of us at Exactech. He instilled and embodied our long-standing company value of Innovation, which has driven our culture since he partnered in our founding nearly 36 years ago. ...
Darin JohnsonCEO, Exactech
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Dr. Miller co-founded Exactech in 1985 with orthopaedic surgeon Bill Petty, MD, and his wife Betty Petty. Since the company’s inception, he has served as its Innovation leader.

Miller received a Bachelor of Science in Mechanical Engineering degree from the University of Florida (UF), a Master of Science in Mechanical Engineering from Massachusetts Institute of Technology and a Doctor of Philosophy in Mechanical Engineering (Biomechanics) from UF. Gary is a UF Distinguished Alumnus and served as associate professor of Orthopaedic Surgery and director of Research and Biomechanics at the UF College of Medicine from July 1986 until August 1996. He also served as an adjunct associate professor in the Department of Aerospace, Mechanics and Engineering Sciences at UF from 1995 until 2010. Miller is a member of many professional societies including the Orthopaedic Research Society, the Society for Biomaterials, and the American Society of Mechanical Engineers. He currently serves on the Board of the Cade Museum for Creativity and Invention and UF’s Wertheim College of Engineering Dean’s Advisory Board, the external advisory boards for UF’s J. Crayton Pruitt Department of Biomedical Engineering, and the Department of Mechanical and Aerospace Engineering, where he is appointed as courtesy professor.

In an announcement to Exactech employees, Dr. Miller reflected, “I’ve been thinking and planning around this retirement idea for several years, and Suzy and I believe now is an excellent opportunity to use our time for travel, family, and other new adventures.  This Exactech journey has been so special. Who would have ever thought that being on an airplane with Dr. Petty more than three-and-a-half decades ago would lead to this incredible idea that is now Exactech. These 36+ years have gone by in a flash because I’ve been able to do what I really like and work with a truly remarkable and wonderful group of people, improving the lives of patients worldwide.”

According to Exactech CEO Darin Johnson, “Dr. Miller has been a brilliant, gregarious and inspiring mentor to many of us at Exactech. He instilled and embodied our long-standing company value of Innovation, which has driven our culture since he partnered in our founding nearly 36 years ago. Employees from every corner of the company, as well as our surgeon partners and sales teams around the world, can bear witness to his engaging and effective Socratic approach to teaching. His patience, expertise and camaraderie have left an indelible mark on this company, and we are grateful he will continue to be around in his Emeritus role.  He may be retiring, but Dr Miller’s legacy will always shine brightly here.”

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About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit staging.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

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Media contact

Priscilla Bennett
Vice President, Corporate Marketing & Communication
352-377-1140

Orthopaedics Just Got Smarter as Exactech’s Active Intelligence® Portfolio Headlines at 2021 AAOS Annual Meeting

Suite of Smart Technologies featured at Booth #1035

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GAINESVILLE, FLA. (Aug. 26, 2021) – Exactech, a developer and producer of innovative implants, instrumentation and smart technologies for joint replacement surgery, announced today its lineup of innovations to be showcased at the company’s educational exhibit, booth #1035, at the American Academy of Orthopaedic Surgeons (AAOS) 2021 Annual Meeting, Sept. 1-3, in San Diego, Calif. The company’s Active Intelligence® platform of technologies will take center stage at this prestigious event, demonstrating the latest in smart solutions, including the application of machine learning, to improve the patient and surgeon experience throughout the journey of care.

Meeting attendees will have the opportunity to experience Active Intelligence through hands-on demonstrations and a sleek touchscreen dashboard. Featured technologies include the following:

Predict+™

  • The newest version of Predict+™, a clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery. With this update, predictions are now based on more patients and more visits—54 coordinated machine learning algorithms. Added outputs include the Smart Score predictive model, the world’s first machine learning-based shoulder arthroplasty-specific outcome measure, and the Internal Rotation Score predictive model.

VERASENSE™

  • VERASENSE™, which helps shoulder surgeons make informed decisions on load magnitude and center of load location in real time.

ExactechGPS® Shoulder and Equinoxe® Planning App

  • ExactechGPS® Shoulder, in combination with the Equinoxe® Planning App, is the first and only shoulder navigation technology that connects the preoperative plan with real-time intraoperative instrument guidance – and verifies implant placement.

ExactechGPS® Knee

  • ExactechGPS® Knee, which provides surgeons with personalized, real-time guidance for primary and revision knee arthroplasty procedures, featuring the Newton™ Ligament Balancer, a new approach to soft tissue management.

Chime

  • Exactech’s Chime mobile application for clinical exchange between surgeons around the world.

exacCoach™

  • exacCoach™, a smart communication platform that will help surgeons connect with and monitor patients before surgery and throughout rehabilitation.

Vantage® Ankle PSI

  • The Vantage® Ankle PSI 3D-printed tibia and talar cutting guides, designed for patients’ unique anatomies and allowing surgeons to pre-plan their cases.

Exactech’s growing platform of Active Intelligence technologies supports the company’s innovative implant systems which will be showcased at the Exactech exhibit.  Surgeons can learn more about clinical success of the Truliant® Primary, Porous and Revision Knee Systems, Equinoxe® Shoulder System, Alteon® Hip System, foot and ankle solutions, including the Vantage® Total Ankle System and EPIC Extremity Foot and Ankle Reconstruction System, as well as the company’s infection-related and biologic solutions.

Surgeons can preview the innovations and educational opportunities showcased at the booth on the Exactech website. Additionally, scientists and surgeon consultants are scheduled at the booth to share their experiences with the company’s latest innovations and technologies.

Visit exac.com for information on Exactech-manufactured and distributed products.

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About Exactech 

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit staging.exac.com for more information and connect with us on LinkedIn, VuMediYouTube Twitter and Instagram.

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Media contact

Priscilla Bennett, APR
Vice President, Corporate Marketing & Communication
352-377-1140

Optimizing Polyethylene Materials to the Application: When it Comes to Manufacturing Methods, Hips are Not Knees

Gary Miller, PhD
Exactech, Inc.

Polyethylene for joint arthroplasty inserts is manufactured in one of three ways. One very common method is to extrude ultra-high molecular weight polyethylene (UHMWPE) powder under pressure and heat, creating a long cylinder of “extruded bar” material that can be cut into sections and machined to its final dimensions (Figure 1).

Figure 1. The ram extruded polyethylene process draws resin into a cylindrical heated chamber and compresses the mass under high temperature and pressure.

The historically popular extrusion consolidation process is inexpensive and fast, but non-consolidated areas of UHMWPE powder and large variability in material properties are often observed. This variability can lead to premature wear and failure of the insert and is not used in Exactech’s hip and knee inserts.

A second method is to place the UHMWPE powder on a larger flat molding form and apply pressure and heat to consolidate a large slab that is cut into smaller pieces and machined into its final shape (Figure 2).

Figure 2. The sheet-molded polyethylene process results in a large slab that is cut into blocks or cylinders and machined to final shape.

The third method, net compression molding, creates specific precision molds for each part to fully mold them one at a time using specialized, computer-controlled equipment that applies implant-specific optimized pressure and temperature and time profiles to both heat and cool the parts using a proprietary formula (Figure 3).

Exactech Polyethlene Process

Figure 3. The net compression molded polyethylene process yields the exact shape of the articular surface.

There are advantages and disadvantages to each manufacturing method. The most important factor to consider, however, is: which method is best for each application?

Wear in hips vs wear in knees

The mechanisms for wear and failure for hips and for knees are quite different due to the differences in congruency of the articulation and the loads applied during activities of daily living. The hip is a congruent “ball and socket” joint with an orbital reciprocating motion. This leads to a dominance of abrasive wear with secondary additional damage caused by femoral neck impingement should it occur. Knees, with their less congruent articulations and rolling and sliding motion, exhibit delamination and pitting as the dominant wear mechanisms with abrasive wear as the tertiary mechanism. Because of this difference in mechanisms, hip and knee inserts benefit from different mechanical properties for their poly inserts. For hips, we look for improved abrasive wear resistance through moderate cross linking of the polymer while maintaining fracture toughness so that locking mechanism failure and cracking from impingment are avoided. In knees, fracture toughness, which is key to reducing or eliminating delamination and pitting, is a key property.

How do manufacturing processes affect wear rate?

To address the wear performance of extruded and sheet molded materials, many manufacturers apply radiation cross linking technologies that increase the cross linking density to decrease the wear rate in hip and knee articulations. While the application of radiation cross linking does improve abrasive wear behavior, it also makes the resulting materials more susceptible to oxidation and other mechanical property degradation, most notably fracture toughness. In an attempt to mitigate these undesirable effects on mechanical properties, post processing heat treatments or antioxidants are used.

There are two general types of highly cross linked UHMWPE with post processing regimens used to address the oxidation and mechanical property degradation. Both have advantages and disadvantages, depending on the application being considered. Annealed highly cross linked UHMWPE still contains residual free radicals making it susceptible to continued oxidation. Re-melted highly cross linked poly has fewer retained free radicals, however, its mechanical and fatigue/fracture toughness properties are compromised with documented potential for structural problems. More recently, antioxidant-treated polymers (vitamin E) have also been introduced, however, the treatment does not fully eliminate oxidation potential, and the long-term effects on the body are unknown.

Does higher cross linking really lead to a better acetabular insert?

Many manufacturers use a high dose of irradiation (up to 100kGy/10MRad) for enhancing cross linking to reduce the amount of volumetric wear. This, however, comes at a cost to some of the mechanical properties of this bearing surface – mainly fracture toughness, as discussed above. Exactech manufactures Connexion GXL® polyethylene components with sheet -molded UHMWPE using two precision split-doses of 25kGy each in vacuum packaging for a total of approximately 50kGy (Figure 4) to create improved cross-link density.

Figure 4. UHMWPE Fracture Toughness measured using 3-point Bend “J-Integral” Testing.6

This process provides a 59 % reduction in gravimetric abrasive wear over the clinically successful standard Exactech polyethylene while maintaining an acceptable level of fracture toughness to mitigate potential edge/impingement and locking mechanism problems (Figure 5).

Figure 5. Wear rates determined by independent lab testing at the J. Vernon Luck Orthopaedic Research Center (McKellop)7. Lysis data determined by Dowd et. al.8

What if you didn’t have to sacrifice fracture toughness to get excellent tibial insert wear rates?

Recognizing that the abrasive wear mechanism for hip implants is quite different from knee components whose dominant wear mechanisms are delamination and pitting (highly affected by fracture toughness), knee insert components made with Exactech’s proprietary net compression molding technology do not require high levels of radiation cross linking and the subsequent post-processing treatments to create the preferred performance properties for knee applications.

All of the articular surfaces of Exactech tibial polyethylene inserts are carefully molded into the part and not machined as in other processes. By the nature of this proprietary, net compression molding consolidation process, the inserts have high fatigue strength, high fracture toughness, low wear rates and are much less sensitive to oxidation after sterilization.

Comparative laboratory testing published by various manufacturers and researchers shows that Exactech’s net compression molded polyethylene has demonstrated approximately 6X less wear than extruded UHMWPE. This is achieved without sacrificing other important mechanical properties. (Figure 6)

Figure 6. Comparative wear rates for several styles of implants and materials show the net compression molded Opterak articulation being among the lowest wear rates when compared to competitive implants.

Conclusion

The longevity and clinical results of total knee and total hip replacement components depend upon many factors. Exactech, using methods that optimize both mechanical and material properties to match the implant design and application, offers significant improvements in implant performance.


References
1. Data on file at Exactech, Inc.
2. McKellop H, Shen FW, Lu B, Campbell P, Salovey R. Development of an extremely wear-resistant ultra high molecular weight polyethylene for total hip replacements. J Orthop Res. 1999 Mar;17(2):157-67.
3. Dowd JE, Sychterz CJ, Young AM, Engh CA. Characterization of Long-Term Femoral-Head-Penetration Rates. Association with and Prediction of Osteolysis. J Bone Joint Surg Am. 2000 Aug;82-A(8):1102-7.
4. Furman BD, Lai S, Stephen Li S. A comparison of knee simulator wear rates between directly molded and extruded UHMWPE. Presented at Society for Biomaterials, 2001.
5. Herrera L, Sweetgall J, Essner, A, Wang A. Evaluation of sequentially cross linked and annealed wear debris. World Biomaster Cong., Amsterdam, May 28-Jun 1, 2008, 583
6. Papannagari R, Hines G, Sprague J, Morrison M. Long-term wear performance of an advanced bearing knee technology. ISTA, Dubai, UAE, Oct 6-9, 2010.
7. Ezzet KA, Hermida JC, Collwell CW, D’Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orhtop 428:120-124, 2004
8. https://www.stryker.com/jointreplacements/sites/triathlon/implants.php 

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