“Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is coming into the U.S. with a proven track record of retaining more healthy anatomy with a less invasive approach and improved outcomes as compared to a total knee replacement,” said Joe Urban, President, Knees at Zimmer Biomet. “We are excited to address the unmet U.S. demand for a cementless partial knee with a new offering that has 20 years of clinical experience in more than 50 countries.”
Compared to traditional partial knee replacements that utilized bone cement to secure implants, the cementless approach enabled natural bone growth to anchor the implant, ensuring better long-term fixation. The Oxford Cementless Partial Knee incorporated a mobile bearing designed to move with the femoral component throughout the range of motion, mimicking natural knee movement. This design enhanced the range of motion, provided a more natural feel, and improved the stability of the implant-to-bone fixation, contributing to long-term implant survival.
The tibial and femoral components of the system were coated with titanium and hydroxyapatite to promote bone integration with the implant. The UK National Joint Registry documented over 33,000 patients treated with Oxford Cementless Partial Knees, achieving a 94.1% implant survival rate at 10 years, outperforming the 10-year survivorship average for all other partial knees (89.9%). The growing enthusiasm for partial knee replacement (PKR) was supported by research demonstrating improved outcomes over total knee replacement (TKR) in suitable cases. This global trend reflected the rising adoption of PKR for better patient outcomes.
“For younger and more active patients, the Oxford Cementless Partial Knee amplifies the benefits of a traditional partial knee replacement by offering knee flexion that resembles natural knee movement, and stronger adhesion of the implant to the bone for better long-term durability,” said Adolph V. Lombardi Jr., MD, FACS, President of JIS Orthopedics in New Albany, Ohio. “In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation.”
As per DelveInsight’s “Partial Knee Arthroplasty Market Report”, the global partial knee arthroplasty market was valued at USD 9.45 billion in 2023, growing at a CAGR of 4.3% during the forecast period from 2024 to 2030 to reach USD 12.48 billion by 2030. The market for partial knee arthroplasty (PKA) is driven by several key factors. Growing incidences of knee osteoarthritis, particularly among the aging global population, are prompting an increased demand for knee replacement procedures, including partial knee replacements, which offer advantages over total knee replacements (TKR). The benefits of PKA, such as faster recovery times, less blood loss, and the preservation of healthy bone and tissue, are encouraging its adoption. Additionally, advancements in implant designs, like cementless systems and mobile-bearing technologies, have improved the long-term outcomes and durability of PKA procedures, fueling market growth. Moreover, rising awareness about the advantages of PKA over TKR, including improved mobility and reduced complications, has also contributed to the expanding market. The increasing preference for minimally invasive surgical options and a focus on personalized medicine further drive the demand for partial knee replacements as a more targeted and effective treatment for knee arthritis.
ReCerf® Hip Resurfacing Arthroplasty, from MatOrtho® Becomes the World’s First All-Ceramic Hip Resurfacing Approved by a Regulatory Authority
On December 3, 2024, MatOrtho, the UK-based global innovator of hip and knee replacement devices, announced that the ReCerf® Hip Resurfacing Arthroplasty became the world’s first all-ceramic hip resurfacing system to receive regulatory approval. Approval from the Therapeutic Goods Administration (TGA) in Australia marked a transformative moment for joint replacement technology and patient care.
The ReCerf Hip Resurfacing System has been delivering exceptional outcomes for patients since September 2018. With over 1,200 patients having received the device, fewer have required further operation than usually anticipated with traditional hip replacement and preexisting hip resurfacing devices at this time point.
TGA approval for ReCerf marks the first regulatory authorisation of its kind globally, setting the stage for further advancements in hip resurfacing technology. MatOrtho continues to work with the Australia Prosthesis List Advisory Committee (PLAC) to have ReCerf included on the next prosthesis list. They are also actively engaged in regulatory approvals in other key markets, to bring the benefits of Ceramic-on-Ceramic Hip Resurfacing with ReCerf to many more patients with the appropriate indications.
“This is a monumental achievement not only for MatOrtho but for the field of orthopaedic surgery,” said Oriol Millet-Lopez, Interim CEO at MatOrtho. “ReCerf represents the culmination of years of innovation and dedication to improving patient outcomes. TGA approval underscores the system’s proven early performance and potential to redefine hip replacement globally.”
As per DelveInsight’s “Hip Replacement Devices Market Report”, the hip reconstruction/replacement devices market was valued at USD 8.82 billion in 2023, growing at a CAGR of 5.04% during the forecast period from 2024 to 2030 to reach USD 11.83 billion by 2030. The hip reconstruction/replacement devices market is growing significantly due to the rising global incidence of osteoarthritis and osteoporosis, increasing numbers of hip fractures, coupled with advancements in joint-replacement technology and innovative product developments by leading companies is expected to escalate the demand for hip reconstruction/replacement devices during the forecast period from 2024 to 2030.
Orthocell Successfully Completed US FDA 510(k) Regulatory Study for Remplir
On December 2, 2024, Regenerative Medicine Company Orthocell Limited announced that it successfully completed its Remplir™ 510(k) nerve repair study, validating the device as safe and effective for surgical repair of peripheral nerves. This U.S. regulatory study formed a critical step in the company’s plans to submit its 510(k) application to the FDA by December 2024. The submission aimed to secure U.S. marketing clearance, with FDA approval expected in the first quarter of 2025, followed by the commencement of commercial distribution shortly afterward.
“We are thrilled with the results from our U.S. Regulatory Study, validating the superior Remplir clinical outcomes, previously published in a highly regarded, peer reviewed journal. The Study results provide key data for the FDA submission to gain market clearance and start selling Remplir in the U.S. We believe Remplir will redefine the nerve repair market and become an important element in the success of nerve repair surgery.” said Orthocell CEO and MD, Paul Anderson.
The study was undertaken in collaboration with highly regarded research scientist Professor Bill Walsh, Director of Surgical and Orthopaedic Research Laboratories at the Prince of Wales Hospital in Sydney and the University of New South Wales, and Professor Minghao Zheng Winthrop Professor of Orthopaedic Research at the University of Western Australia. The Study met all required endpoints and outcomes.
According to DelveInsight’s “Nerve Repair and Regeneration Market Report”, the global nerve repair and regeneration market was valued at USD 6,497.47 million in 2023, growing at a CAGR of 9.31% during the forecast period from 2024 to 2030. The increase in demand for nerve repair and regeneration products is predominantly attributed to the increasing incidence of nerve injuries, the rising prevalence of lifestyle disorders such as diabetes and hypertension, and others. Moreover, technological advancements in the nerve repair product portfolio and high product approvals in recent times, among others are also some of the factors contributing to the global market growth for nerve repair and regeneration. Therefore, the above-mentioned factors are expected to propel the overall market growth of the nerve repair and regeneration market in the forthcoming years.
Hologic Presented New Research Demonstrating How Its Breast Imaging AI Solution Performs Similarly Across Diverse Populations
On December 2, 2024, Hologic, Inc. presented new research demonstrating the performance of its Genius AI® Detection 2.0 software across diverse patient populations at the 110th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA).
Artificial intelligence (AI) has increasingly been used to assist in diagnosing breast cancer, as well as predicting a patient’s risk level and breast density. The creation of AI algorithms began with the collection of large, high-quality databases of patient information and images, which were then used to develop, train, and test the algorithms. These databases had to reflect the diversity of racial and ethnic groups in the population across different regions of the United States to ensure that the algorithms developed minimized any inherent biases, thus reducing disparities for specific patient groups.
“Clinicians across the United States have been leveraging AI solutions in breast cancer screening for many years to drive both clinical and efficiency improvements; however, it’s widely understood that AI algorithms can exhibit racial disparities in a variety of applications,” said Sarah M. Friedewald, MD, Vice Chair for Women’s Imaging, Department of Radiology, Northwestern Feinberg School of Medicine. “This research was a critical step in increasing clinical confidence in this particular AI solution’s ability to deliver results that are not materially impacted by racial bias.”
The research titled “Performance of a Digital Breast Tomosynthesis AI Detection Algorithm in Common U.S. Racial/Ethnic Groups” evaluated Hologic’s Genius AI Detection 2.0 solution in over 7,500 DBT cases from women identified as Asian, Black, Hispanic, or white. The study found the algorithm’s performance to be similar across all racial/ethnic groups. Hologic introduced its next-generation Genius AI Detection PRO solution, which builds upon the 2.0 version by improving accuracy and efficiency. This advanced technology uses deep-learning 2D and 3D algorithms, intuitive case and lesion scoring, and an all-in-one interface, providing radiologists with enhanced confidence and reducing false positives.
According to DelveInsight’s “Diagnostic Imaging Equipment Market Report”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion by 2030. The demand for diagnostic imaging equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population. Therefore, the market for diagnostic imaging equipment is expected to grow during the forecast period from 2024 to 2030.
GE HealthCare Unveiled Sonic DL for 3D, Expanding Deep Learning Innovations in MRI
On December 1, 2024, GE HealthCare unveiled Sonic DL for 3D, the latest addition to its effortless imaging portfolio, designed to speed up MRI scans across various clinical applications. GE HealthCare extended Sonic DL’s capabilities to 3D volumetric imaging, making it applicable for brain, spine, orthopedic, and body exams, alongside cardiac applications. This expansion aimed to achieve the same 12x acceleration and reduce scan times by up to 86%.
In neurology, Sonic DL 3D is designed to enable high-resolution imaging of complex brain structures, allowing for quicker, clearer insights into neurological conditions. In orthopedics, it will help to speed up the imaging of joints, ligaments, and bones, reducing scan times to minimize patient discomfort, especially for those with mobility challenges. By advancing speed and clarity in these critical areas, Sonic DL 3D helps to enhance clinical workflows, improve patient comfort, and support timely diagnoses.
“Today’s unveiling of Sonic DL for 3D reinforces our commitment to advancing medical imaging,” said Kelly Londy, President & CEO, Global MR, GE HealthCare. “Our deep learning, effortless imaging portfolio has already seen great success with AIR Recon DL and Sonic DL for cardiac. Now, with Sonic DL’s expansion to 3D and its ability to combine with AIR Recon DL, we’re offering a combination of speed, accuracy, and clarity. We believe Sonic DL will be a game-changer in key clinical areas, substantially impacting our customers’ ability to deliver high-quality care while enhancing the capabilities of their existing systems through seamless upgrades.”
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market Report”, the global magnetic resonance imaging devices market was valued at USD 7.79 billion in 2023, growing at a CAGR of 6.37% during the forecast period from 2024 to 2030 to reach USD 11.28 billion by 2030. The Magnetic Resonance Imaging Devices market is witnessing positive growth owing to the factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the Magnetic Resonance Imaging Devices market during the forecast period.
Terumo Interventional Systems Announced the Launch of Its R2P NaviCross Peripheral Support Catheter
On December 3, 2024, Terumo Interventional Systems (TIS), a division of Terumo Corporation, launched and made its R2P™ NaviCross® peripheral support catheter commercially available in the U.S. This expanded the company’s radial-to-peripheral (R2P) portfolio. The R2P NaviCross catheter, offered in a 200 cm length, was designed for optimized performance in R2P procedures. Its double-braided, stainless-steel construction provided superior trackability and torque control, making it suitable for crossing lesions in more complex procedures.
“Our customers have been asking for a longer length, high-performance NaviCross support catheter, and I am proud to say we answered the need by delivering R2P NaviCross to the market, further enhancing our radial-to-peripheral portfolio,” said Ghada Farah, Division President, Terumo Interventional Systems. “R2P NaviCross solidifies Terumo’s leadership in radial access, particularly as the demand for procedures to treat peripheral artery disease (PAD) and critical limb ischemia continues to rise.”
“With the 200 cm length, the R2P NaviCross catheter provides physicians performing percutaneous transluminal endovascular procedures from the radial artery a valuable tool to enhance their ability to safely and efficiently complete more procedures from a radial approach,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “Additionally, the double-braided, stainless-steel design of the R2P NaviCross catheter makes it possible to access and cross simple-to-complex lesions above and below the knee.”
The new 200 cm R2P NaviCross catheter rounds out the existing R2P portfolio, including the R2P Destination Slender™ guiding sheath, R2P SlenGuide™ guiding catheter, R2P Misago® self-expanding peripheral stent, and R2P Metacross™ RX and R2P Crosstella™ RX dilatation catheters – giving physicians the confidence to complete almost any PAD procedure from the wrist.
According to DelveInsight’s “Peripheral Vascular Interventions Market Report”, the global peripheral vascular interventions market was valued at USD 8.9 billion in 2023, growing at a CAGR of 6.6% during the forecast period from 2024 to 2030 to reach USD 11.42 billion by 2030. The market for Peripheral Vascular Interventions (PVI) is driven by several key factors. First, the increasing prevalence of peripheral artery disease (PAD) due to aging populations and lifestyle factors such as smoking and diabetes is a significant contributor. Advancements in minimally invasive procedures and technologies, such as drug-coated balloons and stents, have improved patient outcomes and expanded treatment options. The growing demand for non-invasive and outpatient procedures also promotes market growth. Additionally, the rising awareness of PAD symptoms and the benefits of early diagnosis drives patient flow for these interventions. Increased healthcare expenditure and improved reimbursement policies further support the adoption of peripheral vascular interventions. These trends, along with technological innovations in devices and imaging, position the PVI market for continued growth. Therefore, the market for peripheral vascular intervention is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
