FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
On December 23, 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system, the first transcatheter therapy using a transseptal approach, received approval from the US Food and Drug Administration (FDA) for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system was approved for treating patients with symptomatic moderate-to-severe or severe MR who were considered unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, as determined by a multidisciplinary heart team. The indication also included patients with symptomatic mitral valve dysfunction, such as moderate-to-severe or severe MR, severe mitral stenosis (MS), or combined moderate MR and moderate MS associated with mitral annular calcification (MAC), who were not candidates for surgery or TEER therapy.
The SAPIEN M3 TMVR procedure consisted of two steps: delivery of a dock followed by delivery of the valve, resulting in complete replacement of the native mitral valve. Both the dock and the valve were delivered percutaneously through a 29F outer-diameter steerable guide sheath inserted via the femoral vein.
One-year outcomes from the ENCIRCLE single-arm pivotal trial were presented at TCT on October 27, 2025, and were simultaneously published in The Lancet. The trial met all primary and secondary endpoints for safety and effectiveness in the main cohort of 299 patients who were unsuitable for other treatment options, demonstrating substantial MR reduction, with 95.7% of patients achieving MR ≤ 0/1+, along with meaningful improvements in symptoms and quality of life.
The SAPIEN M3 system received CE Mark approval in April 2025, becoming the world’s first approved transfemoral transcatheter mitral valve replacement system. Edwards’ portfolio of FDA-approved transcatheter mitral and tricuspid therapies also included the PASCAL Precision mitral valve repair system and the EVOQUE tricuspid valve replacement system.
“Mitral regurgitation is very common among valvular heart diseases, and these patients often present with debilitating symptoms that are life-threatening and significantly diminish their quality-of-life. Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering,” said David Daniels, MD, Sutter West Bay Medical Group cardiologist and structural heart section chief of Sutter’s Heart & Vascular Service Line. “The SAPIEN M3 system’s ability to provide a fully percutaneous mitral valve replacement that safely delivers near elimination of significant mitral regurgitation and significantly improves their symptoms is a game-changer for these patients.”
As per DelveInsight’s “Transcatheter Mitral Valve Repair Devices Market Report,” the transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.
StimLabs® Announced the FDA Clearance of Theracor™: The First Human Umbilical Cord-Derived Medical Device Sheet
On December 29, 2025, StimLabs announced that the U.S. Food & Drug Administration (FDA) had granted 510(k) clearance for Theracor, making it the first human umbilical cord–derived medical device to be offered in sheet form. This regulatory clearance represented a significant milestone for the wound care industry and further strengthened StimLabs’ position as a leader in this space. Building on the prior clearance of Corplex P®, the first FDA 510(k)–cleared human umbilical cord-derived medical device for wound management in a particulate format, Theracor expanded StimLabs’ product portfolio to address the varying needs of a broad patient population.
Theracor was a sheet-based device derived from human umbilical cord extracellular matrix (ECM) and was intended to cover and protect wounds while maintaining a moist healing environment. It was designed for the same indications as Corplex P, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled or undermined wounds, surgical wounds (such as donor sites and grafts, post-Mohs surgery, post-laser surgery, podiatric wounds, and wound dehiscence), trauma wounds (including abrasions, lacerations, partial-thickness burns, and skin tears), as well as draining wounds. By introducing a sheet-format option, StimLabs enabled clinicians who preferred a continuous application format over a particulate one to access a fully FDA 510(k) cleared, comparable human tissue-based medical device.
“After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare,” said John Daniel, Founder and Chief Executive Officer of StimLabs. “Receiving 510(k) clearance for Theracor underscores our leadership and offers greater options to clinicians and patients who benefit from human tissue-based solutions for the management of acute and chronic wounds.”
“We are thrilled to announce 510(k) clearance of Theracor. By expanding our product portfolio, we empower clinicians with choice and strengthen our commitment to innovating around unmet clinical needs while meeting the highest standards,” stated John Daniel. “With Corplex P already FDA cleared and available nationwide, Theracor rounds out our offering, arming wound care providers with an expanded suite of human umbilical-cord derived devices.”
As per DelveInsight’s “Wound Healing Devices Market Report,” the global wound healing devices market size is expected to increase from USD 28,528.43 million in 2024 to USD 42,320.35 million by 2032, growing at a CAGR of 5.07% during the forecast period from 2025 to 2032. The market of wound healing devices is being primarily driven by the rising prevalence of chronic wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers, among others, increasing surgical procedures and trauma cases, increasing technological advancements in devices, and an increase in product development activities among the key market players.
NGD Infection Prevention Deploys NGD200 System to the Largest Medical Center in the Middle East
On December 30, 2025, NGD Infection Prevention, a global provider of real-time genomic transmission detection solutions for hospitals, announced that it had deployed its integrated transmission detection system at Sheba Medical Center in Ramat Gan, Israel. Sheba Medical Center, the largest hospital in the Middle East and ranked among the top 10 hospitals worldwide, became the first hospital in Israel to implement NGD’s sequencing-based system for early detection and prevention of infectious disease outbreaks.
NGD Infection Prevention’s solution combined low-cost, fully automated sequencing sample preparation with automated bioinformatic analysis and actionable reporting in a single end-to-end system. The NGD200 system was used to perform automated sequencing sample preparation, while the EpiAssist user interface delivered daily transmission reports, including automated root-cause analysis, to support timely interventions by infection prevention teams. This high level of automation enabled adoption in hospital settings, where overnight bacterial sequencing had not been commonly practiced, and supported broad implementation due to its low per-sample cost. As a result, the system delivered a high return on investment by helping shorten patient length of stay, reduce treatment costs, and, most importantly, protect patients from the spread of drug-resistant infections.
“Sheba is a leading evaluator and early adopter of the most effective technologies, and we have been working with them for some time as we planned this installation,” said NGD Director of Strategic Partnerships. “They recognize the unique power of bacterial sequencing to identify transmission as it happens, and know that our complete solution provides the low cost and simplicity of use that makes it practical for a high-volume facility such as Sheba Medical Center.”
“We knew our technology would be needed in Israel,” added Dr. Rhodes, “and recognized that Sheba and other leading medical centers in Israel are rapid evaluators of new technologies and would quickly assess the positive impact that sequencing infection could have on detection of transmission if delivered at the cost, speed of result, and simplicity of use required for practical deployment.”
As per DelveInsight’s “Next-Generation Sequencing Market Report,” the global Next-Generation Sequencing market was valued at USD 9.28 billion in 2023, growing at a CAGR of 18.96% from 2024 to 2030, reaching USD 26.30 billion by 2030. The increase in demand for Next-Generation Sequencing is primarily attributed to the rising cases of infectious diseases, such as the sudden outbreak of COVID-19 and the escalating burden of cancer, worldwide. Moreover, the increasing application of NGS technology in clinical diagnosis and scientific research, and the advantages such as efficient turnaround times, high speed, and accuracy, among others, are factors that would contribute to the global Next-Generation Sequencing market’s growth in the forthcoming years.
Overture Orthopaedics Announced Milestone $1.0M in Sales of its OvertureTi Knee Resurfacing System® to Relieve Pain and Dysfunction Associated with Articular Cartilage Lesions, Osteochondral Defects, and Early Osteoarthritis in the Knee
On December 30, 2025, Overture Orthopaedics, a privately held U.S.-based medical device company focused on innovative joint preservation solutions for sports medicine and orthopedic surgery, announced that it had reached a $1.0 million sales milestone for its award-winning OvertureTi Knee Resurfacing System. The OvertureTi implants were developed as an alternative treatment option for patients who were not yet suitable candidates for arthroplasty but for whom biological repair solutions were not viable in cases of early osteoarthritis and focal cartilage lesions.
The OvertureTi Knee Resurfacing System consisted of femoral and tibial implants designed for partial resurfacing of the knee’s articular surfaces. The system offered multiple sizing options, allowing surgeons to replace only the damaged or diseased area of the joint while preserving healthy native cartilage and surrounding soft tissue. This surgical approach was referred to as Focalplasty®.
Amid a steadily growing active patient population, the annual volume of cartilage restoration procedures had exceeded 300,000 and continued to rise. A 2021 publication by Dekker et al. in The Journal of Bone and Joint Surgery highlighted that existing surgical and biological treatments for isolated knee cartilage defects posed ongoing challenges, including cost, complexity, inconsistent healing, donor-site morbidity, and long-term degradation. Additionally, a study by McCormick et al. examining trends in the surgical treatment of articular cartilage lesions in the United States reported that specific procedures, such as autologous chondrocyte implantation, could reach costs as high as $83,073 due to multi-stage surgical processes, laboratory preparation, extended episodes of care, and broader societal costs.
Overture’s implants incorporated advanced, biocompatible technologies, including 3D-printed porous titanium baseplates designed to promote stable fixation. The articulating surfaces of the femoral and tibial components utilized clinically proven titanium nitride and over-molded, highly cross-linked, vitamin E–treated polyethylene, respectively. Compared with biological treatment options, these implants were positioned as a significantly more cost-effective solution.
“There exists a large and growing group of patients between the ages of 35 and 65 who present with symptomatic articular cartilage lesions and early osteoarthritis of the knee,” said James Young Kim, Overture’s Chief Executive Officer. “These patients are often deemed inappropriate for partial and total knee replacements and are increasingly seeking alternatives to early joint reconstruction, preferring joint preservation options. However, the efficacy of current biologic cartilage repair strategies in joint preservation remains questionable due to long term durability, progressive knee joint catabolism, and prolonged recovery with inconsistent results in middle aged and older patients. Overture’s solution addresses this group with a bridging procedure to delay joint reconstruction so that patients can maintain their active lifestyles for a longer period of their lives.”
According to DelveInsight’s “Knee Reconstruction Devices Market Report”, the knee reconstruction/replacement devices market was valued at USD 7.54 billion in 2023, growing at a CAGR of 4.52% during the forecast period from 2024 to 2030 to reach USD 9.78 billion by 2030. The knee reconstruction/replacement devices market is experiencing significant growth owing to the widespread instances of degenerative bone conditions like osteoarthritis and rheumatoid arthritis, the rise in product development & innovation activities, among others that are acting as key factors, thus contributing to the market growth of the knee reconstruction/replacement devices market during the forecast period from 2024 to 2030.
Envoy Medical Reached Enrollment Milestone in Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant
On December 18, 2025, Envoy Medical® Inc., a hearing health company focused on the development of fully implanted hearing solutions, announced that its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant had reached a significant milestone by achieving the midpoint of its total enrollment target.
The company noted that, despite challenges related to holiday scheduling and year-end operating room availability, patient enrollment was progressing steadily, with participating clinical sites actively screening a large number of potential candidates. Envoy Medical stated that full enrollment remained on track and was expected to be completed within the first half of Q1 2026.
“Reaching the midway point of the study’s enrollment is another strong indication that our pivotal study continues to move forward efficiently,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “Even in a season that traditionally makes scheduling difficult, the investigational sites and our internal teams are performing exceptionally well.”
Lucas added, “We believe our fully implanted approach represents the future of hearing implants. The momentum in our pivotal study and the enthusiasm we are seeing from professionals in the field underscore the strong differentiation of our technology and our leadership as the industry shifts toward fully implanted solutions.”
According to DelveInsight’s ”Cochlear Implants Market Report,” the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs. Investing in cochlear implants & improving access to these devices, along with supportive reimbursement policies, are expected to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
Galaxy Therapeutics Completed Enrollment in Pivotal SEAL IT IDE Trial
On December 23, 2025, Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on the treatment of brain aneurysms, announced that it had completed patient enrollment in SEAL IT, its U.S. Investigational Device Exemption (IDE) trial evaluating the SEAL device for the treatment of brain aneurysms. The multicenter, prospective study involved 50 clinical sites and enrolled 279 patients across three primary aneurysm cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms.
The WNBA cohort was designed to build on the foundation of the earlier WEB-IT trial while expanding the indication to include a broader range of aneurysm sizes. The Sidewall cohort focused on patients with single-vessel, non-bifurcation aneurysms, whereas the Ruptured cohort included patients treated during the acute phase of subarachnoid hemorrhage. Collectively, these cohorts enabled a comprehensive assessment of the SEAL device across a wide range of aneurysm types and clinical treatment scenarios.
“Completing enrollment in SEAL IT is a major milestone not only for Galaxy but for the field of neurointervention,” said Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics. “We designed this study to reflect real-world aneurysm complexity and believe the evidence generated will meaningfully advance the care of these patients.”
“It is impressive that all three arms of the trial progressed so rapidly. It’s a testament to our enrolling physicians’ ability to integrate a new device into their practices and the ease of use of the device itself”, said Dr. Michael Alexander, Galaxy Therapeutics CMO.
“SEAL IT represents an important step in advancing clinical research for complex aneurysms such as wide-neck bifurcations. The design of the study reflects a broad real-world population, and I’m grateful to all participating centers and colleagues,” said Dr. David Altschul, Principal Investigator and Chief of Neurointerventional Surgery at Montefiore Medical Center.
“SEAL IT is one of the first prospective U.S. IDE trials to include a ruptured aneurysm cohort, a critical and underrepresented population in device studies. To our knowledge, it is also among the fastest-enrolling aneurysm studies in the U.S., a testament to the engagement of investigators across the country,” added Dr. Brian Jankowitz, Principal Investigator and Chief of Neurosurgery at Hackensack Meridian Neuroscience Institute. According to DelveInsight’s “Endovascular Aneurysm Repair Devices Market Report”, the endovascular aneurysm repair devices market was valued at USD 2,937.61 million in 2024, growing at a CAGR of 5.85% during the forecast period from 2025 to 2032, to reach USD 4,613.26 million by 2032. The rising incidence of abdominal and thoracic aortic aneurysms (AAA and TAA) is significantly driving the Endovascular Aneurysm Repair (EVAR) market. As the aging population grows, demand for effective, minimally invasive treatments like EVAR increases, given its benefits of reduced hospitalization, lower complication rates, and quicker recovery compared to traditional surgery. Additionally, continuous advancements in EVAR device technology, such as more flexible stent grafts and improved imaging for precise placement, are expanding its applicability to a broader range of patients, further boosting market growth. Together, these factors are expected to increase the demand for endovascular aneurysm repair devices across the globe during the forecast period from 2025 to 2032.
