Zimmer Biomet Announced FDA Breakthrough Designation for World’s First Iodine-Treated Total Hip Replacement System
On October 28, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that the FDA had granted breakthrough device designation for its groundbreaking iodine-treated total hip replacement system, the first product in the company’s history to receive this recognition.
The innovative iodine technology features a controlled-release iodine surface treatment integrated into the iTaperloc® Complete and iG7™ Hip Systems. It is designed to help address infection-related challenges in joint replacement procedures, particularly for patients at elevated risk.
In September, the system received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), making it the world’s first orthopedic implant to use iodine technology. In Japan, it is indicated for inhibiting bacterial adhesion to implant surfaces, a feature aimed at addressing the challenging complication of Periprosthetic Joint Infections (PJI) associated with total joint arthroplasties (TJA). PJIs occur in approximately 1% to 2% of primary TJA cases. They can lead to serious health outcomes, with mortality rates nearing those seen in breast cancer (11%) and significantly higher than those associated with prostate cancer (1%).
“The Breakthrough Device Designation from the FDA underscores the need for innovations to reduce complications that can happen with joint replacement procedures and highlights Zimmer Biomet’s commitment to advancing technologies that improve patient outcomes and enhance the overall success of musculoskeletal health interventions,” said Ivan Tornos, Chairman, President, and CEO. “We look forward to working closely with the agency to bring this first-to-world innovation to patients in the United States.
The iTaperloc® Complete and iG7™ Hip System combines the proven clinical legacy of the Taperloc Complete Hip System with the simplicity, efficiency, and performance of the G7 Acetabular System now enhanced with Iodine Technology. Iodine, a biocompatible and essential nutrient widely used in medicine as an antiseptic, offers antimicrobial benefits without contributing to antibiotic resistance.
The FDA’s Breakthrough Devices Program enables manufacturers to collaborate closely with agency experts throughout the regulatory review process, facilitating the resolution of issues as they arise. As outlined by the FDA, this program prioritizes the review of submissions and provides manufacturers with expedited, constructive feedback to help bring innovative medical technologies to patients more efficiently.
As per DelveInsight’s “Hip Replacement Devices Market Report,” the hip 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 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 hip replacement devices companies, is expected to escalate the demand for Hip Reconstruction Devices during the forecast period from 2024 to 2030.
Terumo Interventional Systems Announced that Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receivd FDA 510(k) Clearance
On October 24, 2025, Terumo Interventional Systems (TIS), a division of Terumo Corporation, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OPUSWAVE® Dual Sensor Imaging System. The system features the DualView® imaging catheter, which has also been granted FDA 510(k) clearance.
The OPUSWAVE Imaging System integrates Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) to provide simultaneous, high-resolution views, empowering physicians with a more comprehensive assessment of coronary artery disease (CAD).
This milestone marks Terumo’s entry into the U.S. imaging market. However, the company is already a well-established leader in single-modality imaging in Japan, where utilization of imaging in percutaneous coronary intervention (PCI) procedures ranks among the highest globally.
“Importantly, the OPUSWAVE Imaging System allows physicians to maximize imaging efficiency without sacrificing quality when it comes to creating treatment plans to achieve the best outcomes for their patients,” said Ghada Farah, President, Terumo Interventional Systems. “By combining the advanced imaging capabilities of OFDI and IVUS into a single catheter, the OPUSWAVE Imaging System also creates a strong opportunity to shorten procedural time and costs in treating CAD.”
What sets the OPUSWAVE® Imaging System apart is its innovative DualView® imaging catheter, designed for exceptional performance and versatility. The catheter offers a maximum pullback length of 150 mm and features a slim 2.6 Fr. Imaging profile with 6 Fr. Guide compatibility, enabling ease of use across a wide range of procedures. It is equipped with an advanced hydrophilic coating for smoother navigation through vessels. It supports a variable pullback speed of up to 40 mm per second in dual mode, ensuring precise and efficient imaging during coronary interventions.
“The OPUSWAVE Imaging System is an ideal technology for interventional cardiologists who perform image-guided PCI,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “This innovative imaging system provides the opportunity for physicians to take advantage of the benefits of both OFDI and IVUS in the assessment and treatment of any lesion morphology. Instead of having to commit to one imaging tool, they now have the flexibility to access both imaging modalities with a single catheter.”
As per DelveInsight’s “Intravascular Ultrasound (IVUS) Market Report” and “Optical Coherence Tomography (OCT) Devices Market Report,” the global Intravascular Ultrasound (IVUS) market was valued at USD 714.85 million in 2021, growing at a CAGR of 7.10% during the forecast period from 2024 to 2030 to reach USD 1,065.26 million by 2030 and the global optical coherence tomography market was valued at USD 1.22 billion in 2023, growing at a CAGR of 8.57% during the forecast period from 2024 to 2030 to reach USD 2.00 billion by 2030. The Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) Devices markets are witnessing positive growth driven by the rising prevalence of ocular and cardiovascular diseases such as cataracts and myocardial infarction, along with risk factors like obesity, diabetes, and hypertension. Additionally, the growing global geriatric population, ongoing technological advancements, and increasing product development and launches are further propelling market expansion from 2024 to 2030.
On October 28, 2025, Medtronic plc, a global leader in healthcare technology, announced that the Centers for Medicare & Medicaid Services (CMS) had issued the final National Coverage Determination (NCD) for renal denervation. The decision applies to the company’s Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity blood pressure procedure. This finalized coverage will enable Medicare patients to access the Symplicity blood pressure procedure as a treatment option for uncontrolled hypertension.
“We are very pleased with the final national coverage determination, which opens up patient access to renal denervation with the Symplicity Spyral RDN system, a safe and durable blood pressure-lowering procedure for patients who have not succeeded with medication or lifestyle changes alone,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options. We congratulate CMS and recognize all the work it took to get to this point.”
The Symplicity Spyral™ RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023, is an advanced, minimally invasive treatment designed to address uncontrolled hypertension. The procedure uses radiofrequency energy to target overactive nerves surrounding the kidneys that contribute to elevated blood pressure. During the procedure, performed under sedation, a physician inserts a thin catheter into the renal artery. Once positioned, controlled energy is delivered to reduce excessive nerve activity. The catheter is then removed, leaving no implant behind, enabling patients to benefit from a durable, device-free approach to blood pressure management.
“We’re proud to be at the forefront of expanding access to minimally invasive therapies and advancing hypertension treatment,” said Skip Kiil, executive vice president and president of the Medtronic Cardiovascular portfolio.”This determination represents a significant opportunity to improve care for patients and opens a novel and meaningful market for Medtronic, positioning our renal denervation technology as one of the most exciting growth drivers for the company. Our commercial teams will be actively leveraging this milestone, collaborating closely with healthcare providers and hypertension centers as we accelerate the adoption of this transformative growth opportunity for Medtronic.”
The Symplicity Spyral™ RDN system is now available at leading medical centers across the United States, including major integrated delivery networks that have incorporated the procedure into their hypertension care programs.
Medtronic continues to collaborate closely with physicians and healthcare organizations to facilitate the adoption of this innovative technology and expand patient access to the therapy. Globally, the Symplicity Spyral RDN system has been approved for commercial use in nearly 80 countries, reflecting its growing role in the management of uncontrolled hypertension worldwide.
According to DelveInsight’s “Blood Pressure Monitoring Devices Market Report,” The global blood pressure monitoring devices market is expected to increase from USD 2,842.32 million in 2024 to USD 6,086.50 million by 2032, reflecting strong and sustained growth. The global blood pressure monitoring devices market is projected to grow at a CAGR of 10.01% during the forecast period from 2025 to 2032. The demand for blood pressure monitoring devices is primarily driven by the rising prevalence of hypertension and cardiovascular diseases, the increasing shift towards home healthcare & remote patient monitoring, technological advancements in devices, and an increase in product development activities among key market players.
West Synchrony™ Prefillable Syringe System Launched at CPHI: Redefining a System-level Solution for Drug Delivery
On October 27, 2025, West Pharmaceutical Services, Inc., a global leader in innovative injectable drug delivery solutions, announced the launch of its West Synchrony™ Prefillable Syringe (PFS) System at CPHI Worldwide in Frankfurt, Germany. This advanced system represents a major advancement in drug delivery technology, providing a fully verified, end-to-end platform from a single supplier. The West Synchrony™ PFS System is expected to be commercially available in January 2026.
The West Synchrony™ PFS System offers a fully verified, system-level solution specifically engineered for the delivery of biologics and vaccines. It establishes a new benchmark in drug delivery by streamlining syringe selection and development, supported by comprehensive performance validation and regulatory data packages that help accelerate time to market.
“Leaders in drug development face pressures to meet milestones efficiently amid complex challenges, amongst them, selecting prefillable syringes. They currently rely on fragmented approaches—assembling component data from multiple suppliers or outsourcing piecemeal verification, which risks delays, increased costs and regulatory setbacks,” said Andy Polywacz, President of Integrated Systems at West. “With West Synchrony prefillable syringe system, it enables pharmaceutical companies to streamline design, accelerate regulatory submission, and secures a reliable supply chain for combination products that meets quality and volume needs.”
The West Synchrony™ PFS System offers several key advantages designed to optimize performance, regulatory efficiency, and supply reliability. Its single, fully verified design and system-level performance package from West ensures consistent form, fit, and function across the entire prefillable syringe platform. The system also simplifies regulatory processes by providing a unified submission supported by a comprehensive Drug Master File (DMF) and regulatory package, enabling faster, more efficient approvals. Additionally, West’s single-source supply approach provides both make-to-stock and make-to-order options with low minimum order quantities, ensuring flexibility, reliability, and continuity of supply for pharmaceutical partners.
According to DelveInsight’s “Prefilled Syringes Market Report”, the prefilled syringes market was valued at USD 12,490.79 million in 2024, growing at a CAGR of 10.73% during the forecast period from 2025 to 2032 to reach USD 27,993.35 million by 2032. The global prefilled syringes market is growing due to the rise in chronic diseases, increased use of biologics and biosimilars, and the adoption of self-administration. Chronic conditions like diabetes and rheumatoid arthritis require ongoing injectable treatments, and prefilled syringes offer patients a safe, convenient way to manage their care. The use of biologics and biosimilars for complex conditions like cancer and autoimmune diseases has further driven demand for user-friendly injection systems. Additionally, the shift towards self-administration at home enhances convenience and boosts the overall demand for prefilled syringes. Collectively, these factors foster a robust growth trajectory for the prefilled syringes market during the forecast period from 2025 to 2032.
Emboline, Inc. Completed Enrollment in U.S. Pivotal IDE Trial of the Emboliner® Embolic Protection Catheter Designed to Protect Patients from Embolic Injury During Transcatheter Aortic Valve Replacement
On October 23, 2025, Emboline, Inc., a leading innovator in full-body embolic protection technologies for transcatheter procedures, announced the completion of patient enrollment in its Protect the Head to Head (ProtectH2H) Clinical Trial. This pivotal Investigational Device Exemption (IDE) study (NCT05684146) is evaluating the safety and effectiveness of the Emboliner® Embolic Protection Catheter in patients undergoing Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI). Enrollment for the trial began in May 2023.
The ProtectH2H trial is a prospective, randomized, open-label, multicenter study that enrolled 500 patients across 18 leading clinical sites in Brazil, Germany, and the United States. The study’s primary endpoints include 30-day major adverse cardiac and cerebrovascular events (MACCE), 30-day VARC-2 stroke, and assessment of acute embolic debris capture.
Completion of enrollment marks a major milestone in Emboline’s mission to advance comprehensive, full-body embolic protection for transcatheter procedures—where embolic debris is generated in every case. With this progress, the company moves closer to equipping interventional cardiologists with an effective solution to safeguard patients from embolic complications during transcatheter heart interventions.
“We are very excited to have completed enrollment in this important trial, which we hope will bring us closer to being able to offer our patients comprehensive embolic protection for TAVR and other structural heart procedures,” said Tamim Nazif, MD, Director of Clinical Research in Cardiology at Columbia University Irving Medical Center and Co-Principal Investigator for the Protect the Head to Head study. “The use of a full body embolic filter with debris capture and removal will provide a significant level of confidence that we are doing all we can to protect our patients from stroke and other embolic complications.”
“This important milestone would not have been possible without the enthusiastic support of our investigators and their research teams in the United States, Brazil, and Germany. I am also quite proud of the effort and dedication of the entire Emboline team, especially the outstanding clinical, quality and product development teams who went above and beyond to support this study. We are excited to move towards submission for regulatory approval in the US and Europe, and finally having the Emboliner available to all interventionalists to protect their patients from the shower of debris released during transcatheter heart procedures.” said Scott Russell, President and CEO of Emboline. “Additionally, the trust in our investigational device that we have seen from our investigators reinforces our confidence that the Emboliner is truly a universal protection device with the potential for much broader applicability beyond TAVR.”
In addition to the IDE study, investigators participating in the ProtectH2H trial also utilized the Emboliner® Embolic Protection Catheter in approximately 20 compassionate-use and emergency-use cases involving other high-risk interventional procedures with significant embolic potential. These procedures included thrombus and vegetation extraction, aortic and mitral valve-in-valve interventions, leaflet modification, and left atrial appendage occlusion. The use of the Emboliner in these cases highlights both its capability to provide comprehensive, full-body embolic protection and the growing clinical confidence among physicians in this investigational device.
A review of 10 of these exceptional cases will be presented at TCT 2025 in San Francisco on October 28, by Dr. Tamim Nazif and Dr. Emily Tat of Columbia University Irving Medical Center.
“We are excited to present some of the first examples of full body embolic protection in very high embolic risk patients undergoing TAVR and other structural heart procedures,” said Dr. Nazif. “We look forward to further investigating the utility of the Emboliner for improving the safety of our procedures in these very challenging patient populations.”
The Emboliner® is the first device designed to deliver comprehensive brain and body protection against ischemic events, such as stroke, that can result from embolic debris entering the bloodstream during transcatheter heart procedures. Although transcatheter valve technologies and procedural techniques have advanced significantly over the past two decades since the introduction of TAVR, the risk of a significant, debilitating stroke remains a severe and persistent concern. For many patients, this risk is often regarded as even more frightening than the possibility of death itself, underscoring the critical need for effective embolic protection solutions like the Emboliner.
According to DelveInsight’s “Embolic Protection Devices Market Report,” The global embolic protection devices market size is expected to increase from USD 648.51 million in 2024 to USD 1,161.31 million by 2032, reflecting strong and sustained growth. The global embolic protection devices market is projected to grow at a CAGR of 7.58% during the forecast period from 2025 to 2032. The demand for embolic protection devices is primarily driven by rising cases of cardiovascular and neurovascular disorders, growing awareness of cardiovascular and stroke risks associated with medical procedures, and technological advancements.
Laborie Announced First Procedures in ENDURE 1 Study with the Optilume® Ureteric Drug-Coated Balloon
On October 28, 2025, Laborie Medical Technologies, a global leader in diagnostic and therapeutic medical devices, announced the successful completion of the first procedures using the Optilume® Ureteric Drug-Coated Balloon (DCB) in the ENDURE 1 clinical study. These landmark procedures represent a significant advancement in the treatment of benign ureteric strictures, offering a novel therapeutic option for patients affected by this challenging condition.
The initial procedures were performed by Dr. Jaime Landman at the University of California, Irvine Health, along with other participating investigators. The ENDURE 1 trial (NCT07020520) is a prospective, multicenter study designed to evaluate the safety and feasibility of Optilume for the treatment of benign ureteric strictures measuring up to 4 centimeters in length. The Optilume DCB integrates mechanical dilation with the localized delivery of paclitaxel, a well-established antiproliferative drug, to help prevent scar tissue recurrence and promote long-term ureteral patency.
Ureteric strictures, characterized by the narrowing of the ureter due to scar tissue formation, can result from kidney stones, prior surgery, radiation therapy, or trauma. The condition often causes pain, infection, and potential kidney damage. Existing treatment options, such as repeat dilations or stent placements, are frequently associated with recurrence, while severe cases may require invasive reconstructive surgery. The Optilume DCB offers a minimally invasive alternative that enhances patient outcomes, maintains ureteral patency, and may reduce the need for repeat interventions.
“We are proud to achieve this important milestone for Optilume in the ureters,” said Chris Smith, CEO of Laborie. “This innovation builds on the proven clinical success of Optilume in anterior urethral strictures and represents a significant step toward expanding treatment options for patients with limited choices.”
The ENDURE 1 study will enroll up to 60 patients across multiple clinical sites in the United States, with follow-up extending over five years. The trial’s key endpoints include technical success, freedom from retreatment, improvements in kidney function, and patient-reported outcomes, all aimed at evaluating the long-term safety, efficacy, and durability of the Optilume® Ureteric Drug-Coated Balloon (DCB) in the management of benign ureteric strictures.
“Patients with ureteric strictures have limited durable solutions and face significant challenges, including the risk of severe kidney damage,” said Dr. Landman. “Optilume’s novel combination of dilation and drug delivery has the potential to transform how we treat this notoriously difficult condition.”
According to DelveInsight’s “Drug Eluting Balloons Market Report”, the global drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases, including peripheral and coronary artery diseases. Furthermore, the growing preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population, and others will drive demand for drug-eluting balloons in the coming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and development activities by key players, among others, are contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2024 to 2030.
