Announcements

 

Wright Medical Announces FDA Pre-Market Approval For Additional Sizes Of CARTIVA® Synthetic Cartilage Implant (SCI) Device

CARTIVA SCI will now be available in 6 mm and 12 mm

Wright Medical, a global leader in the orthopedic extremities market, today announced that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for commercial distribution of the CARTIVA® Synthetic Cartilage Implant (SCI) in two additional sizes, 6 mm and 12 mm. Additionally, the company received approval of labeling to incorporate the post approval study results now that the FDA has closed out the post approval study and have concurred that Wright Medical has met all the requirements.

The CARTIVA SCI is intended to treat hallux rigidus, or osteoarthritis of the big toe, the most common arthritic condition in the foot.1 First approved in 2016, the CARTIVA SCI has been available in two sizes, 8 mm and 10 mm, for selection by the physician. The additional dimensions of 6 mm and 12 mm offer physicians and patients more options to customize implantation for a more accurate fit. The approval came as a result of Wright Medical’s 180-day supplement, which confirmed that the device’s indication remains the same for the newly-approved dimensions.

“We understand that no two patients are the same, and every patient deserves a journey tailored to their needs – from diagnosis to treatment,” expressed Patrick Fisher, President of Lower Extremities and Biologics at Wright Medical. “We pursued this expansion of the CARTIVA SCI device to offer a more comprehensive, customizable range of sizes to meet the needs of both physicians and patients.”

CARTIVA SCI offers an alternative to the historical standard of care, fusion surgery, by not only reducing pain and improving foot function but also preserving toe movement.3 The procedure can provide long-term pain reduction and motion preservation, but time and proper recovery are critical to unlocking the benefits of the CARTIVA SCI. On average, patients will start to experience clinically meaningful pain reduction and functional improvement after six to nine months that will continue to improve over time. In a post-approval, multi-center, prospective, randomized study, the long-term benefit of the CARTIVA SCI was demonstrated in patients who experienced 97% reduction in pain at 5.8 years post-procedure, and 93% of patients were satisfied and said they would have the procedure again.4

“It’s exciting that we can now offer patients suffering from hallux rigidus treatment options like the CARTIVA SCI that can reduce pain without sacrificing range of motion,” said Judith Baumhauer, M.D., M.P.H., Professor and Associate Chair of Academic Affairs, University of Rochester Medical Center. “The expansion of the CARTIVA portfolio to add new sizes allows me to not only feel more confident in treating a broader range of patients, but also to ensure optimal patient outcomes.”

Big toe arthritis affects 1 in 40 people over the age of 50.2 Patients suffering from big toe arthritis often experience tenderness, achiness and pain which over time can develop into joint stiffness that makes even walking painful.3 Many patients will assume that the only surgical option is fusion surgery, a procedure that relieves pain, but eliminates motion of the big toe in the process. The CARTIVA SCI is a safe and effective surgical implant solution that can reduce pain and preserve long‐term mobility.4

Commercial launch of the CARTIVA SCI in 6 mm and 12 mm is expected to begin in the second half of 2019. For more information about the CARTIVA SCI, visit www.Cartiva.net.

About Wright Medical
Wright Medical Group N.V. is uniquely positioned with leading technologies and specialized sales forces in three of the fastest growing areas of orthopedics – Upper Extremities, Lower Extremities and Biologics. That leadership is further enhanced by one of the most comprehensive extremity and biologic product portfolios in the industry as well as strong platforms for future new product development. From new material technologies to advanced products and instrumentation, Wright is committed to delivering innovative, value-added solutions improving quality of life for patients worldwide.

About Cartiva SCI
Cartiva’s Synthetic Cartilage Implant (SCI) is indicated for treating arthritis at the base of the great toe and received U.S. Premarket Approval in July 2016.1 The SCI is composed of a biocompatible, durable, low-friction organic polymer that functions similarly to natural cartilage and can be implanted in about 35 minutes.1 Unlike fusion, Cartiva reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion.3,5 Due to a less restrictive rehabilitation protocol, Cartiva patients typically return to function and activities of daily living faster than patients who undergo a fusion procedure.5

REFERENCES

  1. CARTIVA® Synthetic Cartilage Implant Instructions for Use (IFU)
  2. Gould N, Schneider W, Ashikaga T. Epidemiological Survey of Foot Problems in the Continental United States: 1978‐1979. Foot Ankle. 1980;1:8–10
  3. Baumhauer JF, Singh D, Glazebrook M, et al. Prospective, Randomized, Multi‐centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2016;37(5):457‐469.
  4. Glazebrook, M, Blundell C, O’Dowd D, et al. Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2019;40(4):374-383.
  5. Glazebrook MA, Younger ASE, Daniels TR, et al. Treatment of First Metatarsophalangeal Joint Arthritis Using Hemiarthroplasty with a Synthetic Cartilage Implant or Arthrodesis: A Comparison of Operative and Recovery Time. Foot Ankle Surg. 2017-May-29

 

Wright Medical Group N.V. Expands ORTHOLOC™ 3Di Product Line with New, Type II Anodized Small Bone Plating System

ORTHOLOC 3Di Small Bone Plating System Features Anatomic, Low-Profile Plates Designed to Improve Intraoperative Adaptability with Fracture-Specific Implant Options

Wright Medical Group N.V., a global leader in the orthopaedic extremities market, announced that it builds on its robust foot and ankle portfolio with the availability of the ORTHOLOC 3Di Small Bone Plating System, providing clinicians with a low profile, comprehensive plating solution designed to address metatarsal fractures.

The ORTHOLOC 3Di Small Bone Plating System provides a new level of surgical flexibility and performance through a broad range of plating options that include low-profile utility plates, three different fifth metatarsal fracture plates, and a proprietary pinch plate designed to facilitate distal metatarsal osteotomies and fractures. Over 55,000 forefoot fractures occur each year and approximately half occur at the 5th metatarsal. An increasing incidence of osteoporotic bone in an aging population is expected to lead to a 10.5% average annual procedural growth rate.1,2

“The ORTHOLOC 3Di Small Bone Plating System combines low profile and anatomically contoured plates with the versatility of 2.0 or 2.4 variable angle locking screws,” said Dr. Christopher Hyer, Orthopedic Foot & Ankle Center, Westerville, Ohio. “This set is the definitive forefoot trauma tray in my operating room.”

Key benefits of the ORTHOLOC 3Di Small Bone Plating System include:

  • The Capability to Address Variations in Anatomy and Fracture Patterns – ORTHOLOC 3Di variable angle locking screw technology allows for customized screw trajectories paired with rigid, locked fixation
  • Reduced likelihood of Soft-Tissue Irritation and Patient Discomfort – Plates feature Type II anodization that allow for a thinner profile without compromising strength3
  • Increased Intraoperative Flexibility – System includes 3 different plates designed to address 5th metatarsal fractures, a variety of utility plates and a proprietary pinch plate that can ease fixation of metatarsal neck fractures and segmental shortening osteotomies

“The ORTHOLOC 3Di Small Bone Plating System is an excellent example of Wright Medical’s commitment to providing new, innovative solutions for foot & ankle pathologies,” said Guy Guglielmino, Vice President, Lower Extremities Global Marketing, Wright Medical. “This system not only offers utility plates for addressing a variety of indications, but it also enhances adaptability by offering plate options designed specifically for more challenging fracture patterns.”

About the ORTHOLOC 3Di Small Bone Plating System
The ORTHOLOC 3Di Small Bone Plating System is intended for use in the stabilization of fresh fractures, revision procedures, joint fusions, and reconstruction of small bones of the hands, feet, wrists, ankles, fingers, and toes. The system can be used in both adult and pediatric patients.

For more information about ORTHOLOC 3Di Small Bone Plating System, please visit http://www.wright.com/footandankleproducts/ortholoc-3di-small-bone-plating-system.

More information on Wright Medical’s products can be found at www.wright.com.

1. SmartTrak Data
2. Millennium Research Group
3. Compared to ORTHOLOC 2.0/2.4 Forefoot System, Data on file


 

Wright Medical Group N.V. Expands Foot & Ankle Portfolio with GRAVITY™ SYNCHFIX™ Syndesmosis Fixation Device

GRAVITY SYNCHFIX is the Market’s First Syndesmosis Fixation Device Designed to Preserve More Bone

Wright Medical Group N.V., the global leader in the orthopaedic extremities market, announced that it builds on its robust foot and ankle portfolio with the availability of GRAVITY SYNCHFIX Syndesmosis Fixation Device, allowing clinicians to provide secure, dynamic fixation across the ankle syndesmosis. GRAVITY SYNCHFIX offers low-profile syndesmosis fixation device that allows for flexible fixation and preserves bone and soft tissue, while facilitating ligament healing.

Syndesmosis fixation is necessary when patients suffer from ankle trauma, including fractures, which often cause damage to the fibular and tibular syndesmosis ligaments. In order for the ligaments to heal properly, the fibula and tibia bones must be stabilized. It is estimated that over 145,000 ankle fractures occur each year in the United States, a number that is growing by 10% annually due to an aging population (SmartTrak 2017).

“The GRAVITY SYNCHFIX technique allows me to position the device’s medial button directly on-bone and avoid
impingement of nearby neurovascular structures,” said Brian Den Hartog, MD, Twin Cities Orthopedics. “This helps ensure consistent results and reduces the likelihood of patient discomfort.”

Key benefits of GRAVITY SYNCHFIX include:

  • Preservation of Fibular and Tibial Bone Stock – Extraosseous medial button attachment allows for a reduced 2.8mm pilot hole compared to the market average for ankle syndesmotic devices, which may minimize stress risers and improve fixation
  • Technique Minimizes Soft-Tissue and Neurovascular Impingement – Mini-Open medial approach ensures optimal button placement, reducing the likelihood of patient discomfort from impinged tissue
  • Reduced Incidence of Hardware Removal – Flexible design stabilizes the syndesmosis and minimizes the need for removal, which commonly occurs with screw fixation1

“The GRAVITY SYNCHFIX device builds on Wright Medical’s new line of fracture solutions designed specifically for the Foot & Ankle Surgeon,” said Patrick Fisher, President, Lower Extremities, Wright Medical. “When paired with the new ORTHOLOC™ 3Di Ankle Fracture LP System, surgeons can simultaneously address ankle fractures and syndesmotic injuries.”

About GRAVITY SYNCHFIX
The GRAVITY SYNCHFIX Syndesmosis Fixation Device is intended to provide fixation during the healing process following trauma to the ankle syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.

The GRAVITY SYNCHFIX Syndesmosis Fixation Device may be used for definitive treatment as the sole fixation device, or used in conjunction with other Wright Medical lower extremity products, including, but not limited to the ORTHOLOC 3Di Ankle Fracture LP System.

For more information about SYNCHFIX, visit: http://www.wright.com/footandankleproducts/gravity-synchfix-syndesmosis-fixation-device.

More information on Wright Medical’s products can be found at www.wright.com. 016184A_24-Oct-2017

1. Walley KC, Hofmann KJ, Velasco BT, Kwon JY. Removal of hardware after syndesmotic screw fixation: a systematic literature review. Foot Ankle Spec 2017;10:252-257


 

Wright Medical Announces First Patient Implanted in U.S. INFINITY™ Total Ankle System Post-Market Study; Provides Update on UK Post-Market Study

Company expands leadership position in total ankle replacement by initiating one of the largest data collection studies globally for total ankle replacement surgery

U.S. Study Recruitment Commences
Wright Medical Group N.V., a global leader in the orthopaedic extremities market, today announced the first patient implanted in the U.S.-based INFINITY™ Total Ankle System Follow-Up Study at the Campbell Clinic in Memphis, Tennessee.

The primary objective of the multi-center, non-randomized, prospective study of 200 patients is to evaluate 10-year implant survivorship in patients with ankle joints damaged by severe rheumatoid arthritis, post-traumatic arthritis, or degenerative arthritis who received the INFINITY™ Total Ankle System for primary ankle arthroplasty.

The secondary objective is to characterize the improvements after implantation with the INFINITY™ Total Ankle System over a 10 year period using patient reported outcome measures related to quality of life, pain and functional scores, as well as x-ray assessments.

“With the growing popularity and increasing demand for alternatives to ankle fusion, there is a real need for quality, forward-looking studies that document the results of total ankle replacement surgery to further validate our clinical decision making,” said Dr. G. Andrew Murphy of the Campbell Clinic and a Primary Investigator for the study. “Wright Medical is leading the way in this progress, and we expect to glean valuable data from this study of the INFINITY™ Total Ankle System.”

UK Study Progresses
In 2016, Wright Medical launched the post-market INFINITY™ Total Ankle study in the UK. The multi-center, non-randomized, prospective study of 500 total ankle replacement patients will evaluate 10 year implant survivorship and outcomes throughout the lifecycle of the INFINITY™ Total Ankle System. Wright has enrolled more than 100 patients across multiple sites in the UK, including England and Scotland, as of Q3 2017. As in the U.S.-based study, the secondary objective of the UK study is to characterize improvements after implantation with the INFINITY™ Total Ankle System over a 10-year period.

“It is increasingly important for industry and clinicians to work together to provide patients, colleagues and healthcare providers with robust clinical evidence to support new systems,” said Mr. David Townshend, MBBS FRCS (Orth), Consultant Orthopaedic Surgeon, Northumbria NHS Healthcare Trust, UK and Chief Investigator for the study. “We are delighted that Wright has taken the opportunity to sponsor a high quality multi-centre follow-up study in the United Kingdom to evaluate the INFINITY™ total ankle replacement, and we look forward to sharing these results.”

“The undertaking of both the US and UK post-market clinical studies are a testament to Wright’s ongoing commitment to foot and ankle surgeons and their patients,” said Ann Burgess, VP Global Clinical Affairs, Wright Medical. “By collecting longitudinal patient outcomes through real-world experience of non-design surgeons at centers of excellence around the globe, Wright will generate important information that will drive the continued evolution of the treatment and technologies addressing end-stage ankle arthritis for years to come.”

Of the roughly 50,000 end-stage ankle arthritis patients in the US each year, an estimated 8,000 will receive a total ankle replacement in 2017 and the rest will receive an ankle fusion or conservative care. With an ankle fusion, patients undergo a surgical operation where screws or plates are used to join or “fuse” the bones of the tibia and the talus in order to create a solid and immobile ankle joint with the goal to alleviate pain. Patients who receive a total ankle replacement undergo a surgical operation where ankle replacement implants are used to resurface the ends of the tibia and talus that have been damaged from ankle arthritis, with the intent to help alleviate pain and maintain mobility in the ankle joint.

About the INFINITY Total Ankle System 
The INFINITY™ Total Ankle System combines a low-profile implant design and seamless integration with PROPHECY™ Pre-Operative Navigation Alignment Guides. It also features a distinctive talar resurfacing option for preservation of talar bone and a tibia design that is compatible with the Company’s existing INBONE™ II System.

The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Individual results and activity levels after surgery vary and depend on many factors including age, weight and prior activity level. There are risks and recovery times associated with surgery and there are certain individuals who should not undergo surgery. More information on Wright Medical’s products can be found at www.wright.com.


 

Wright Medical Group N.V. Expands Diabetic Foot Reconstruction Product Line with New SALVATION™ Quick Struts

Salvation Quick Struts Allow Fast, Acute Adjustments to a Patient’s External Frame during Limb Salvage Procedure

Wright Medical Group N.V., a global leader in the orthopaedic extremities market, announced that it builds on its line of limb salvage offerings with the availability of SALVATION Quick Struts, now affording clinicians the ability to make dynamic, acute corrections real time. SALVATION offers the market’s first and only comprehensive solution for Charcot arthropathy and advanced midfoot reconstruction, helping patients avoid full and partial foot amputations.

Charcot Foot is a serious condition that results from neuropathy, usually the result of diabetes. This condition results in the breakdown of the foot inflammation and damage affecting joints, bones, and soft tissues of the foot. Studies have suggested that as many as 13% of all diabetic patients and 29% of neuropathic patients may be affected with this condition. In the U.S., there are an estimated 51,000 new Charcot patients per year.

“SALVATION Quick Struts allow me to use the external fixation frame to make quicker corrections and adjustments for my patients while they are undergoing a limb salvage procedure,” said Carroll Jones, MD, OrthoCarolina. “This allows me to restore alignment, while also providing the necessary compression to the limb we are saving. They offer improved ease-of-use, flexibility and stability, which, in turn, benefits my patients.”

Key features of the SALVATION Quick Struts include:

  • Variable sizes – Short, medium and long sizes, each overlapping each other for maximum modularity. Each kit comes with four of each of the three sizes.
  • Double Ball Joint Locking Capabilities – Locking ball joints provide a large degree of angular correction, giving surgeons multiple fixation options.
  • Macro/Micro Compression Distraction – The telescoping strut body provides quick macro compression/distraction. Adjustment knobs allow surgeons to dial in micro-adjustments both intra- and post-operatively.

“The introduction of SALVATION Quick Struts is a significant addition to Wright’s External Fixation System for limb salvage,” said Patrick Fisher, President, Lower Extremities, Wright Medical. “The introduction of our new Quick Struts components marks another step in the company’s objective to offer total solutions that benefit both clinicians and patients alike.”

About the SALVATION External Fixation System
The SALVATION™ External Fixation System is designed to address fractures, nonunions, and complex foot and ankle deformities including Charcot neuroarthropathy. The system relies on proven techniques utilizing tensioned thin wires, half-pins and rings. The SALVATION External Fixation System incorporates many new features to assist with proper frame positioning and increase frame application efficiency. The slotted ring design allows for frame components to be attached quickly and easily, while minimizing the need to assemble small, threaded components together.

The system includes components to assist in the positioning of the foot and lower leg within the frame and maintaining appropriate position throughout the surgery. In addition, the Wire Guide allows for precise placement of the wire on the ring to minimize the need for additional connection components and decrease additional surgical steps.

The SALVATION External Fixation System may be used for definitive treatment as the sole fixation device, or used in conjunction with the SALVATION Beams and Bolts or the SALVATION 3Di Midfoot Plating System. For more information about SALVATION, visit: http://www.wright.com/healthcare-professionals/salvation/salvation-external-fixation-system.

More information on Wright Medical’s products can be found at www.wright.com.