The Motiva® SmoothSilk® Round and Ergonomix® implants represented state-of-the-art innovation in plastic surgery. These devices featured the patented SmoothSilk® surface, which was designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva® SmoothSilk Ergonomix® device was the first breast implant in the world to embody the science of ergonomics, as it was designed to adapt, react, feel, and move like natural breast tissue. Unique to the implant market, Motiva® SmoothSilk® Ergonomix® implants could adapt their shape as the body changed position, maintaining a round shape when lying down and a teardrop shape when standing. The Motiva® SmoothSilk® Round implants provided increased upper breast fullness and softness while maintaining a round full form regardless of position.
“The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results, with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort,” said board-certified plastic surgeon Dr. Caroline A. Glicksman. “As the Medical Director of the Motiva study and an investigator, I am proud of the quality of the data and the patient follow-up rates of this study. Motiva implants were designed to reduce device related complications, and they will be welcomed by the plastic surgery community and women seeking breast augmentation in the United States.”
The Motiva U.S. IDE Study took place at 32 centers in the U.S. and three centers in Western Europe. At the conclusion of the study, three years post-implantation, patient compliance in the primary augmentation cohort of the trial was documented at 92.4%. The Kaplan-Meier risk rates for the first occurrence of complications at three years for patients (with a 95% confidence interval) in the primary augmentation cohort (N=451) showed Capsular Contracture at 0.5%; Rupture, confirmed or suspected, at 0.6% (MRI Cohort N=176); Breast Pain at 0.7%; and Infection at 0.9%. The rate of any reoperation, which included changes in implant size, was noted at 6.1%, while the overall complication rate, including reoperations, was reported at 8.4%.
As per DelveInsight’s “Breast Implants Market Report”, the global breast implants market was valued at USD 1.93 billion in 2023, growing at a CAGR of 7.00% during the forecast period from 2024 to 2030, to reach USD 2.89 billion by 2030. The increase in demand for breast implants is predominantly attributed to the growing incidence of breast cancer among the population across the globe. In addition, the rise in demand for cosmetic surgeries among women to enhance their aesthetic appeal could also be a potential factor for increasing the market for breast implants. Moreover, an increase in the number of breast augmentation surgeries and technological advancement in the product portfolio is expected to bolster the breast implant market during the forecast period.
Surmodics Received FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter
On October 01, 2024, Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ XL Thrombectomy System.
“Securing FDA clearance for the Pounce XL Thrombectomy System is a major step forward in Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, notably critically ischemic lower extremity vessels,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The Pounce Thrombectomy Platform has already demonstrated its performance as a rapid, efficient solution for the removal of both acute and chronic thrombi and emboli in peripheral arteries without the use of thrombolytics. The addition of the Pounce XL Thrombectomy System to our Pounce Thrombectomy Platform demonstrates our commitment to setting the pace and direction of innovation in this critical space.”
The Pounce XL Thrombectomy System had been intended for the non-surgical removal of thrombi and emboli from peripheral arterial vessels ranging from 5.5 to 10 mm in diameter, making it appropriate for iliac, femoral, and other arteries of this size. This system greatly expanded the size range of the Pounce Thrombectomy Platform, which also featured the Pounce Thrombectomy System for 3.5-6 mm peripheral arteries and the Pounce LP (Low Profile) Thrombectomy System for 2-4 mm peripheral arteries. The Pounce Thrombectomy System and Pounce LP Thrombectomy System were launched in 2021 and 2024, respectively.
Surmodics expects to initiate a limited market release for the Pounce XL Thrombectomy System in the first half of 2025, with commercialization planned following the completion of the limited market release.
As per DelveInsight’s “Thrombectomy Devices Market Report”, the global thrombectomy devices market is poised for significant growth, projected to achieve a remarkable CAGR of 5.24% during the forecast period from 2024 to 2030. The demand for thrombectomy devices is being boosted by the increasing prevalence of lifestyle disorders such as low blood pressure, diabetes, obesity, age, and others. Further, the increasing prevalence of venous thromboembolism, cardiovascular diseases, cancer, and neurological diseases such as ischemic stroke, hemorrhagic stroke, and peripheral diseases, among others will lead to the formation of blood clots, thereby leading to the increased demand for thrombectomy devices. In addition, the increasing demand for minimally invasive approaches for treatment, lack of physical activity, rising adoption of smoking, rising device launches and approvals, surging innovations in product development, and shifting key players’ focus towards the development of technologically advanced product and initiatives to increase awareness regarding neurovascular diseases and their prevention among others are thereby contributing to the overall growth of the thrombectomy devices market during the forecast period from 2024 to 2030.
Synergy Spine Solutions Announced the Completion of Patient Enrollment in the Synergy Disc® 2-Level IDE Clinical Trial
On September 25, 2024, Synergy Spine Solutions Ltd, an orthopedic medical device company focused on artificial cervical disc replacement, completed patient enrollment in its U.S. 2-Level IDE clinical trial.
Conducted under a U.S. Investigational Device Exemption (IDE), the 2-Level trial evaluated the safety and effectiveness of the Synergy Disc® artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease in subjects who were symptomatic at two contiguous levels from C3 to C7. The Synergy Disc trial was a multi-center, prospective, non-randomized, historically controlled study conducted on 200 patients at 24 clinical sites in the U.S.
Dr. Pierce Nunley, an orthopedic spine surgeon at the Spine Institute of Louisiana, has been involved in multiple cervical total disc replacement (TDR) trials. “I am impressed with the ease and safety of use in surgery,” he said. “The Synergy Disc is unique in that it is the only disc that offers a lordotic core designed to maintain or restore sagittal alignment.” “Additionally, the design is ideal for multi-level disc surgery, so the combination of these attributes will help expand the overall patient population and indications of TDR. It certainly has the potential of being a surgeon’s “go to” disc in this growing field of cervical TDR.”
Dr. Armen Khachatryan, an orthopedic spine surgeon based in West Jordan, Utah, has been involved as an investigator in several cervical TDR trials including both the Synergy Disc 1-Level and 2-Level studies. “I am honored to serve as a principal investigator in the Synergy 2-Level IDE trial,” he said. “The Synergy Disc represents a significant advancement in spinal surgery, featuring innovative design elements such as lordotic core options, titanium alloy endplates, and a highly stable biomechanical core. The straightforward implantation technique makes it a versatile option for both single and two-level procedures. Upon anticipated US FDA approval, the Synergy Disc will also be indicated for use in a setting where a patient had a prior cervical fusion, offering surgeons enhanced options for choosing disc arthroplasty at other cervical levels and increasing the overall disc replacement market. I eagerly anticipate incorporating this disc into my surgical practice.”
The completion of patient enrollment in the 2-Level IDE clinical trial represented a critical milestone in the company’s pursuit of US FDA regulatory approval(s) and accelerated Synergy Disc’s overall time to market.
According to DelveInsight’s “Spinal Fusion Devices Market Report”, the global spinal fusion devices market was valued at USD 6.49 billion in 2023, growing at a CAGR of 4.55% during the forecast period from 2024 to 2030 to reach USD 8.47 billion by 2030. The rise in demand for Spinal Fusion Devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, disc herniation, spinal stenosis among the growing old-age population worldwide; increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line, and new product launches among others are also expected to drive the global spinal fusion market.
Medtronic Announced the New Clinical Data Demonstrated Excellent Lesion Durability With PulseSelect™ Pulsed Field Ablation System in Real-World Setting as Approvals and Adoption Expand Globally
On September 27, 2024, Medtronic plc., a global leader in healthcare technology, presented clinical study results that demonstrated a high rate of durable lesion formation for the PulseSelect™ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). Approximately two months post-ablation, invasive remapping with the Pulse Select PFA System indicated durable isolation in 98% of pulmonary veins (PV), with 96% of patients showing complete vein isolation.
“Real-world evidence on chronic lesion formation and durability is critical as use of PFA for the treatment of Afib rapidly increases, making these results impactful and timely for the electrophysiology community,” said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard’s Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas. “Our research shows that treatment with PulseSelect results in durable lesion formation, which is the cornerstone of successful pulmonary vein isolation and an important addition to previous evidence establishing the safety and effectiveness of this technology.”
A total of 25 AFib patients with persistent or paroxysmal AFib (56% paroxysmal, 52% male, 69±9 years) underwent pulmonary vein isolation (PVI) with the PulseSelect PFA System. Invasive remapping conducted in all patients (57±9 days post-ablation) demonstrated durable isolation in 98% of pulmonary veins (PVs) (102/104), and 96% of patients (24/25) had all veins isolated. All index ablation procedures were performed using intracardiac echocardiography and electroanatomical mapping (EAM) without fluoroscopy. General anesthesia was administered to 24 of the 25 patients, and all patients were discharged on the same day. The average skin-to-skin procedure time was 36 minutes, and acute PV isolation was achieved in 100% of patients. There were no complications during an average follow-up period of 74 days.
Prof. Hiroshi Tada, Professor of the Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan, and President of the Japanese Heart Rhythm Society, said “PulseSelect is the first PFA catheter to receive reimbursement approval in Japan based on clinical trial results that include Japanese patients. We believe that the future widespread availability of this breakthrough technology under insurance coverage will be of great significance in the history of arrhythmia treatment in Japan.”
“These important results clearly address the durability question and add to the real-world evidence for PulseSelect,” said Rebecca Seidel, president, the Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. With the expansion in new markets across the Asia Pacific region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency, and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with AFib.”
According to DelveInsight’s “Ablation Devices Market Report”, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2024 to 2030. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmias such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
Globus Medical Launched the Next Wave of Orthopedic Trauma Solutions
On October 02, 2024, Globus Medical, Inc., a leading musculoskeletal solutions company, announced the continued growth and expansion of its orthopedic trauma product portfolio. Globus introduced several new system extensions in 2024 and received 510(k) clearance from the U.S. Food and Drug Administration for its first suture-based product, the TENSOR™ Suture Button System. Among the newly launched next-generation systems were the ANTHEM™ II Distal Radius Volar Plates, AUTOBAHN™ Trochanteric Nail PRO Instruments, and CAPTIVATE™ SOLA Headless Screws.
“The addition of these products to our growing orthopedic trauma portfolio signifies our continued responsiveness and dedication to surgeons and patients,” said John Mulcahy, Chief Commercial Officer and President of Orthopedics.
“The contour of the ANTHEM™ II Volar Plates and comprehensive fixation options allow me to further customize my surgical plans and achieve an anatomic fit,” said Dr. Ilyas. “I am excited for the continued use of the ANTHEM™ Distal Radius system in my practice.”
The TENSOR™ Suture Button System is engineered to redefine suture management in the operating room. The system features a self-locking suture and an inserter with integrated tensioning handles, which provides a streamlined approach for tensioning through a single incision. TENSOR™ is compatible with ANTHEM™ Ankle and One-Third Tubular Plates, offering surgeons a complete ankle solution. The system also features a two-hole washer kit that can aid in the repair of isolated syndesmotic injuries.
The ANTHEM™ Distal Radius Fracture System is a comprehensive fixation system designed to treat a wide variety of wrist fractures with anatomically contoured plates for intraoperative versatility. Market-leading polyaxial locking technology allows for ±20° of angulation (40° cone) in polyaxial volar, fragment specific, and diaphyseal metaphyseal plates. MonoAx™ locking technology enables a thin volar plate design to facilitate distal plate placement in the treatment of complex, intra-articular fractures. Innovative instruments allow for secure retraction and streamlined plate positioning, drilling, and screw insertion.
The AUTOBAHN™ Trochanteric Nailing System is designed to treat a variety of pertrochanteric femur fractures. The PRO Instrument Set and Distal Targeting System allow for an efficient and streamlined surgical workflow.
The CAPTIVATE™ SOLA Headless Compression Screw System offers a flexible and efficient solution to address fracture repair, bone reconstruction, osteotomy, and arthrodesis procedures through ample implant options and shared instruments for paired screw sizes. Screw diameters include 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.5, 6.5, and 7.5mm in lengths ranging from 10-140mm. All screws are available in stainless steel and titanium alloy, with options for short and long partial threads. Small and large modular graphic cases house all nine screw diameters and corresponding instrument modules.
According to DelveInsight’s “Orthopedic Trauma Devices Market Report”, the global orthopedic trauma devices market was valued at USD 7.01 billion in 2023, growing at a CAGR of 6.43% during the forecast period from 2024 to 2030 to reach USD 10.15 billion by 2030. The orthopedic trauma devices market is growing significantly due to the increasing cases of degenerative bone-related disorders such as osteoarthritis & rheumatoid arthritis, the growing number of sports-related injuries causing trauma, and increased instances of fractures that are acting as major factors in escalating the demand for orthopedic trauma devices during the forecast period from 2024 to 2030.
Medtronic Expanded AiBLE™ Spine Surgery Ecosystem With New Technologies and Siemens Healthineers Partnership
On September 25, 2024, Medtronic plc., a global leader in healthcare technology, announced the commercial launch of several software, hardware, and imaging innovations at the North American Spine Society 39th Annual Meeting in Chicago. These enhancements aimed to advance AiBLE™, the Medtronic smart ecosystem of innovative navigation, robotics, data and AI, imaging, software, and implants that facilitated more predictable outcomes in spine and cranial procedures. In alignment with its commitment to improving the quality of care for patients with spinal conditions, Medtronic also revealed a partnership with Siemens Healthineers to explore opportunities for expanding access to advanced pre- and post-operative imaging technologies for spine care.
New advancements in the AiBLE™ ecosystem build upon the company’s commitment to procedural innovation and execution, and included O-arm™ 4.3 software, UNiD™ Adaptive Spine Intelligence (ASI), Mazor™ robotic guidance system, and new implant innovation with ModuLeX™ Spinal System.
The O-arm™ 4.3 software introduced advanced navigation volumes, dose reduction, and enhanced image confirmation. With this release, Medtronic provided the industry’s longest 3D scan length for cone-beam CT images, enabling surgeons to capture additional spine levels in a single scan and streamline their workflow. The O-arm™ was the first and only intraoperative imager to utilize AI, delivering 70% less radiation dose compared to the standard protocol while maintaining image quality. Additionally, the Medtronic Implant. Resolution (MIR) feature further improved decision-making by reducing metal artifacts around select screws, allowing for confident final screw placement.
UNiD™ Adaptive Spine Intelligence (ASI), an integrated service and software platform by Medtronic, previously leveraged AI and predictive models to assist surgeons in delivering patient-specific surgical plans and implants. It now included MRI Vision, which integrated with CoLumbo from Smart Soft Healthcare into the UNiD™ workflow. This new tool employed computer vision technology to automatically analyze lumbar MRIs, segment, label, and measure key aspects related to common pathologies. MRI Vision enabled spine surgeons using UNiD™ ASI to access automated PDF reports and annotated DICOMs in the UNiD™ Hub, facilitating the identification and quantitative measurement of areas of interest, such as muscle area with fat infiltration and key spinal alignment angles. UNiD™ was powered by over 28,000 patient procedures and continued to gain adoption worldwide.
The Mazor™ robotic guidance system with 5.1 software was the first and only spinal robotic system that integrated AI, bone cutting, and graft delivery. It enabled comprehensive preoperative and intraoperative planning, extending beyond screw placement to include complete construct design with screws, rods, interbodies, and bone removal. The latest version of the 5.1 software introduced Maximum Intensity Projection (MIP), which supported improved image quality.
“Partnering with Siemens Healthineers advances our commitment to reduce variability and improve outcomes for spinal patients,” said Skip Kiil, president of Medtronic Cranial & Spinal Technologies, which is part of the Medtronic Neuroscience Portfolio. “We are thrilled with the prospect of working with the industry leader in imaging and to leverage the depth of imaging experience and expertise, commercial footprint, and shared commitment to data science to advance our AiBLE strategy and shared pursuit of better patient outcomes.”
“We are excited about the prospect of partnering with Medtronic to bring our solution to spine centers and empower spine surgeons and neurosurgeons to be more precise in the operating room,” said Verena Schoen, Executive Vice President X-ray Products at Siemens Healthineers. “Multitom Rax™ delivers geometrically accurate images which allows precise measurements of the patient’s vertebrae. Especially optimized for spine imaging, it not only contributes to faster diagnosis and treatment planning, but also to surgical execution and post-surgical control.”
According to DelveInsight’s “Spinal Surgery Devices Market Report”, the global spinal surgery devices market is estimated to grow at a CAGR of 5.65% during the forecast period from 2024 to 2030. The spinal surgery devices market is observing remarkable market growth owing to various factors such as the subsequent rise in spinal disorders across the globe, increasing road accidents, and increasing demand for minimally invasive surgical procedures among others. Further, the increasing demand for technologically advanced spinal surgery devices in the market will also spur market growth in the forthcoming years. Additionally, a rise in spending on spinal surgery products along with the increasing product launches and approvals, and other factors will create a requisite for the spinal surgery devices in the market. Therefore, the market for spinal surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
