{"id":34977,"date":"2026-04-09T17:31:32","date_gmt":"2026-04-09T12:01:32","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=34977"},"modified":"2026-04-09T17:31:34","modified_gmt":"2026-04-09T12:01:34","slug":"medtech-news-for-waters-medcad-bd","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd","title":{"rendered":"Waters Receives FDA Approval for Advanced HPV Self-Collection and Testing Kit; MedCAD Achieves FDA 510(k) Clearance for AccuStride\u00ae Tib\/Fib Anatomical Solution; Mercy Medical Center Expands IBD Care with Office-Based Intestinal Ultrasound; BD Introduced Next-Generation TIPS Innovation to Enhance Portal Hypertension Care in the European Union; KingstronBio Completes First ProStyle M\u00ae Mitral Valve Implant in Confirmatory Trial; MiRus Launches Enrollment for STAR Randomized Study of Siegel\u2122 TAVR System"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69d7d224dcc44\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69d7d224dcc44\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#Waters_Announced_the_FDA_Clearance_of_the_Most_Comprehensive_At-Home_Cervical_Cancer_Screening_Tool_the_Onclarity_HPV_Self-Collection_Kit_and_FDA-Approved_HPV_Assay\" >Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#MedCADs_AccuStride%C2%AE_Received_FDA_510k_Clearance_for_New_Anatomical_Lower_Leg_Region_TibFib_Solution\" >MedCAD&#8217;s AccuStride\u00ae Received FDA 510(k) Clearance for New Anatomical Lower Leg Region Tib\/Fib Solution&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#Mercy_Medical_Center_Introduced_Office-Based_Intestinal_Ultrasound_to_Enhance_Care_for_Patients_with_Inflammatory_Bowel_Disease\" >Mercy Medical Center Introduced Office-Based Intestinal Ultrasound to Enhance Care for Patients with Inflammatory Bowel Disease&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#BD_Delivered_Next%E2%80%91Generation_TIPS_Innovation_to_Advance_Portal_Hypertension_Care_Across_the_European_Union\" >BD Delivered Next\u2011Generation TIPS Innovation to Advance Portal Hypertension Care Across the European Union<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#First_Implant_of_KingstronBios_ProStyle_M%C2%AE_Transcatheter_Mitral_Valve_System_Successfully_Completed_in_National_Multicenter_Confirmatory_Study\" >First Implant of KingstronBio&#8217;s ProStyle M\u00ae Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-waters-medcad-bd\/#MiRus_Begins_Patient_Enrollment_in_the_STAR_Randomized_Trial_of_the_Siegel%E2%84%A2_Transcatheter_Aortic_Valve\" >MiRus Begins Patient Enrollment in the STAR Randomized Trial of the Siegel\u2122 Transcatheter Aortic Valve&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-waters-announced-the-fda-clearance-of-the-most-comprehensive-at-home-cervical-cancer-screening-tool-the-onclarity-hpv-self-collection-kit-and-fda-approved-hpv-assay\"><span class=\"ez-toc-section\" id=\"Waters_Announced_the_FDA_Clearance_of_the_Most_Comprehensive_At-Home_Cervical_Cancer_Screening_Tool_the_Onclarity_HPV_Self-Collection_Kit_and_FDA-Approved_HPV_Assay\"><\/span><strong>Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 08 April 2026, Waters Corporation announced that the U.S. Food and Drug Administration had cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a major advancement in improving access to cervical cancer screening. This milestone aimed to reduce barriers that had previously prevented many individuals from undergoing routine screening.<\/p>\n\n\n\n<p>Cervical cancer, largely preventable through regular screening and early detection of human papillomavirus infection, has remained a significant health concern, with nearly 60% of cases occurring in individuals who were unscreened or under-screened. The introduction of at-home self-collection was recognized as a key strategy to improve early diagnosis and reduce mortality rates.<\/p>\n\n\n\n<p>The self-collection kit was designed to be used with the BD Onclarity HPV Assay, which detects high-risk carcinogenic HPV genotypes and provides one of the most comprehensive screening capabilities available. Samples were processed using the automated BD COR\u2122 System, which utilized advanced robotics to ensure accurate and reliable results.<\/p>\n\n\n\n<p>Waters Corporation had collaborated with the National Cancer Institute under the Cervical Cancer \u201cLast Mile\u201d Initiative SHIP Trial to validate the effectiveness of self-collection testing. The company also stated that it was working on partnerships to expand nationwide access, with the kit expected to become available by prescription and covered under insurance programs such as Medicare and Medicaid.<\/p>\n\n\n\n<p><em>&#8220;Expanding access to screening is one of the most important steps we can take to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete,&#8221; said Jeff Andrews, M.D., FRCSC, Vice President of Medical Affairs, Waters Advanced Diagnostics, Waters Corporation. &#8220;As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades, I have seen firsthand the profound difference early detection makes for patients. When more patients are able to get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner. That allows us to spend less time trying to reach patients who have fallen behind on screening and more time focusing on prevention, follow-up care, and treatment for those who need it.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/molecular-diagnostics-market\"><strong>Molecular Diagnostics Market Report<\/strong><\/a>,\u201d the molecular diagnostics market was valued at <strong>USD 9.56 billion<\/strong> in 2024, growing at a <strong>CAGR of 9.21%<\/strong> during the forecast period from 2025 to 2032, to reach <strong>USD 16.12 billion<\/strong> by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B, and Hepatitis C, Influenza, and human papillomavirus (HPV). The introduction of new and innovative products by key molecular diagnostics companies, among others, is expected to drive the molecular diagnostics market from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-medcad-s-accustride-received-fda-510-k-clearance-for-new-anatomical-lower-leg-region-tib-fib-solution-nbsp\"><span class=\"ez-toc-section\" id=\"MedCADs_AccuStride%C2%AE_Received_FDA_510k_Clearance_for_New_Anatomical_Lower_Leg_Region_TibFib_Solution\"><\/span><strong>MedCAD&#8217;s AccuStride\u00ae Received FDA 510(k) Clearance for New Anatomical Lower Leg Region Tib\/Fib Solution&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 08 April 2026, MedCAD announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for its AccuStride\u00ae lower leg tibia and fibula system, enabling surgeons to access patient-specific precision devices for orthopedic procedures. The system\u2019s custom-designed planning and surgical guides allowed orthopedic surgeons to address multiple related pathologies and perform osteotomies within a single procedure.<\/p>\n\n\n\n<p>The company had previously received 510(k) clearance for its foot and ankle guides and planning system in March 2025, followed by clearance for its fixation plates in November 2025. With the latest approval, MedCAD completed its patent-pending AccuStride\u00ae system for lower extremities, covering tibia\/fibula as well as foot and ankle applications.<\/p>\n\n\n\n<p>The AccuStride\u2122 system included surgical guides, fixation plates, and anatomical models, all designed using patient imaging data and surgeon-approved plans. These components were manufactured using UV-curable acrylate polymers or titanium alloys and could be delivered within five days of design approval. The system was intended for patients aged 12 years and above.<\/p>\n\n\n\n<p>The surgical guides provided precise, tactile placement during procedures, while being compatible with FDA-cleared cutting and drilling instruments. Additionally, the anatomical models offered a visual representation of patient-specific anatomy, helping surgeons plan and execute procedures with greater accuracy.<\/p>\n\n\n\n<p><em>&#8220;MedCAD&#8217;s newly announced, patient-matched surgical guides are unlike anything else available for surgeons who routinely perform complex or revision lower leg region cases,&#8221; said Nancy Hairston, CEO and president of MedCAD. &#8220;Interest from leading orthopedic specialists eager to use our solutions for multiple pathologies is very promising, and we expect these custom 3-D printed devices to reduce the frequency and duration of surgeries, and to deliver high quality, durable outcomes.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/orthopedic-devices-market\"><strong>Orthopedic Devices Market Report<\/strong><\/a>,\u201d the global orthopedic devices market was valued at <strong>USD 44.09 billion<\/strong> in 2023, growing at a <strong>CAGR of 4.78%<\/strong> during the forecast period from 2025 to 2032 to reach<strong> USD 57.79 billion<\/strong> by 2032. The orthopedic devices market is slated to witness increasing revenue owing to factors such as a growing population of people above the age of 65, a rise in the cases of bone disorders such as osteoarthritis and osteoporosis among others, increasing cases of occupational injuries and non-occupational injuries along with latest technological developments in healthcare technology are further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mercy-medical-center-introduced-office-based-intestinal-ultrasound-to-enhance-care-for-patients-with-inflammatory-bowel-disease-nbsp\"><span class=\"ez-toc-section\" id=\"Mercy_Medical_Center_Introduced_Office-Based_Intestinal_Ultrasound_to_Enhance_Care_for_Patients_with_Inflammatory_Bowel_Disease\"><\/span><strong>Mercy Medical Center Introduced Office-Based Intestinal Ultrasound to Enhance Care for Patients with Inflammatory Bowel Disease&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 08 April 2026, Mercy Medical Center expanded its advanced digestive health services by introducing intestinal ultrasound (IUS) at The Melissa L. Posner Institute for Digestive Health &amp; Liver Disease. This technology provided patients with inflammatory bowel disease, including Crohn&#8217;s disease and ulcerative colitis, a convenient and noninvasive method to evaluate intestinal inflammation during routine clinical visits.<\/p>\n\n\n\n<p>Traditionally, IBD had been monitored using colonoscopy, laboratory tests, CT scans, and MRI, which often required bowel preparation, sedation, or radiation exposure, and did not always provide immediate results. However, intestinal ultrasound offered a bedside solution that allowed physicians to assess the bowel in real time without the need for radiation, anesthesia, or special preparation.<\/p>\n\n\n\n<p>The procedure could be completed during a standard appointment, enabling faster clinical decision-making and improved communication between physicians and patients. The technology had already been widely used internationally and was increasingly recognized for its ability to quickly detect inflammation, differentiate active disease from symptoms, monitor treatment response, and reduce dependence on invasive diagnostic methods.<\/p>\n\n\n\n<p>According to the Centers for Disease Control and Prevention, the prevalence of IBD had been rising in the United States, affecting approximately 2.39 to 3.1 million adults. By incorporating intestinal ultrasound into its services, Mercy Medical Center strengthened its commitment to patient-centered care by improving accessibility, comfort, and quality of treatment for individuals with complex digestive disorders.<\/p>\n\n\n\n<p><em>&#8220;Intestinal ultrasound gives us the ability to evaluate inflammation at the time of an office visit,&#8221; said Dr. Cross. &#8220;Because patients are awake and involved during the exam, they can see and understand what&#8217;s happening in their intestines. That shared, real-time insight strengthens our ability to personalize treatment and monitor how therapies are working.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/ultrasound-devices-market\"><strong>Ultrasound Devices Market Report<\/strong><\/a>,\u201d the global ultrasound devices market size is expected to increase from <strong>USD 9,315.06 million<\/strong> in 2024 to <strong>USD 13,054.68 million<\/strong> by 2032, growing at a <strong>CAGR of 4.38% <\/strong>during the forecast period from 2025 to 2032. The global ultrasound device market is growing due to the rising prevalence of chronic diseases, increasing demand for early and accurate diagnosis, and the expanding use of minimally invasive procedures. Advancements in ultrasound technology, such as 3D\/4D imaging, AI integration, and portable handheld systems, are further driving adoption across hospitals, diagnostic centers, and point-of-care settings. Growing awareness of prenatal care and maternal health, coupled with the aging population, has also boosted demand for ultrasound in obstetrics and cardiology. Additionally, ultrasound is cost-effective, safe, and radiation-free compared to other imaging modalities, making it a preferred diagnostic tool. Expanding healthcare infrastructure in emerging markets and favorable government initiatives to enhance access to imaging services are further contributing to market growth.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-bd-delivered-next-generation-tips-innovation-to-advance-portal-hypertension-care-across-the-european-union\"><span class=\"ez-toc-section\" id=\"BD_Delivered_Next%E2%80%91Generation_TIPS_Innovation_to_Advance_Portal_Hypertension_Care_Across_the_European_Union\"><\/span><strong>BD Delivered Next\u2011Generation TIPS Innovation to Advance Portal Hypertension Care Across the European Union<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 08 April 2026, BD (Becton, Dickinson and Company) announced that it had applied for CE Mark approval for its Liverty\u2122 TIPS Stent Graft, aiming to expand treatment options for patients across the European Union suffering from complications related to portal hypertension. The next-generation device was designed to improve outcomes in patients with cirrhosis by offering an adjustable-diameter solution for transjugular intrahepatic portosystemic shunt (TIPS) procedures.<\/p>\n\n\n\n<p>Cirrhosis has remained a major global health concern, affecting approximately 58 million people worldwide, and often leads to portal hypertension, which could cause severe complications such as variceal bleeding and fluid accumulation. TIPS procedures were commonly used to reduce portal pressure and improve blood flow in such patients.<\/p>\n\n\n\n<p>The Liverty\u2122 TIPS Stent Graft had been engineered with an adjustable inner diameter ranging from 6\u201310 mm and offered a wide range of covered stent lengths. It featured a flexible, self-expanding nitinol frame and dual-layer ePTFE encapsulation with carbon impregnation, and was delivered through a triaxial system designed to enhance placement accuracy and ease of use.<\/p>\n\n\n\n<p>Additionally, BD (Becton, Dickinson and Company) stated that safety and effectiveness data from the ARCH clinical trial, a global, prospective, multi-center study evaluating the device, would be presented by Ziv Haskal at the Society of Interventional Radiology Annual Scientific Meeting on April 12, 2026.<\/p>\n\n\n\n<p><em>&#8220;For patients living with complications of portal hypertension, access to safe, effective and adaptable treatment options is critical,&#8221; said Rima Alameddine, worldwide president of Peripheral Intervention at BD. &#8220;With CE Marking of the Liverty\u2122 TIPS Stent Graft, we&#8217;re introducing an innovative, adjustable solution that helps physicians personalize therapy and improve the potential for long\u2011term outcomes.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/interventional-radiology-devices-market\"><strong>Interventional Radiology Devices Market Report<\/strong><\/a>,\u201d the global interventional radiology devices market is expected to grow at a<strong> CAGR of 5.23%<\/strong> during the forecast period of 2021-2030. The increase in demand for interventional radiology devices is primarily attributed to the increasing patient pool due to an increasing prevalence of chronic disorders &amp; cancer, and due to the increasing number of geriatric patients globally. The interventional radiology devices work on minimally invasive techniques, so it involves less severe surgical procedures, thereby leading to a shorter hospitalization period. Thus, the rising demand of the reducing healthcare expenditure across the world is anticipated to bolster the market of the devices. Furthermore, the rising awareness and demand of minimally invasive techniques and the technological advancements in devices, such as illumination rendering technology, real-time images, and others across the world, are anticipated to bolster the market, thereby contributing to the growth of the interventional radiology devices market during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-first-implant-of-kingstronbio-s-prostyle-m-transcatheter-mitral-valve-system-successfully-completed-in-national-multicenter-confirmatory-study-nbsp\"><span class=\"ez-toc-section\" id=\"First_Implant_of_KingstronBios_ProStyle_M%C2%AE_Transcatheter_Mitral_Valve_System_Successfully_Completed_in_National_Multicenter_Confirmatory_Study\"><\/span><strong>First Implant of KingstronBio&#8217;s ProStyle M\u00ae Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 09 April 2026, KingstronBio Technology (Changshu) Co., Ltd. announced that the first implantation of the ProStyle M\u00ae Transcatheter Mitral Valve System had been completed on March 12, 2026, under pure ultrasound guidance as part of its confirmatory clinical study. The procedure was carried out by Wang Chunsheng and Wei Lai at Zhongshan Hospital Affiliated to Fudan University, marking the official initiation of the national multicenter confirmatory clinical trial for the ProStyle M\u00ae system.<\/p>\n\n\n\n<p>Prior to this milestone, the device had undergone a two-year First-in-Man (FIM) study involving 10 patients with an average age of 71 years. The results had demonstrated strong anchoring performance, with no cases of regurgitation reported. Ongoing clinical studies were expected to further validate the safety and effectiveness of the device.<\/p>\n\n\n\n<p>KingstronBio Technology (Changshu) Co., Ltd. has been actively focusing on innovation in the heart valve segment, developing several proprietary technologies such as Micro-Ex\u2122 anti-calcification treatment and AirBo\u2122 dry storage technology to enhance the durability and biocompatibility of heart valves. The company\u2019s broader portfolio included artificial bioprosthetic valves, annuloplasty rings, cardiac patches, and transcatheter valve systems.<\/p>\n\n\n\n<p>The ProStyle M\u00ae system had been designed to address key challenges in transcatheter mitral valve replacement, including complex anatomy and risks such as left ventricular outflow tract obstruction. Its eccentric structural design enabled improved anchoring, reduced procedural complexity, and enhanced hemodynamic performance, offering a promising treatment option for patients with moderate to severe mitral regurgitation.<\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201d<a href=\"https:\/\/www.delveinsight.com\/report-store\/transcatheter-mitral-valve-repair-devices-market\"><strong>Transcatheter Mitral Valve Repair Devices Market Report<\/strong><\/a>,\u201d the transcatheter mitral valve repair devices market was valued at <strong>USD 1,197.06 million<\/strong> in 2023, growing at a <strong>CAGR of 14.95%<\/strong> during the forecast period from 2024 to 2030 to reach <strong>USD 2,756.71 million<\/strong> 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 &amp; 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.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mirus-begins-patient-enrollment-in-the-star-randomized-trial-of-the-siegel-transcatheter-aortic-valve-nbsp\"><span class=\"ez-toc-section\" id=\"MiRus_Begins_Patient_Enrollment_in_the_STAR_Randomized_Trial_of_the_Siegel%E2%84%A2_Transcatheter_Aortic_Valve\"><\/span><strong>MiRus Begins Patient Enrollment in the STAR Randomized Trial of the Siegel\u2122 Transcatheter Aortic Valve&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 08 April 2026, MiRus announced that it had successfully enrolled and treated the first patients in the STAR Trial, a prospective, multicenter, randomized controlled study evaluating the Siegel\u2122 8-Fr aortic transcatheter heart valve (THV). The initial procedures were performed at Piedmont Heart Institute by Pradeep K. Yadav and Vinod H. Thourani.<\/p>\n\n\n\n<p>The STAR Trial (Siegel Transcatheter Aortic Valve Replacement Trial) had been designed to assess the safety and effectiveness of the Siegel\u2122 THV in patients suffering from severe, symptomatic aortic stenosis, including those at low, intermediate, and high surgical risk.<\/p>\n\n\n\n<p>The Siegel\u2122 valve incorporated a low-profile delivery system and demonstrated strong hemodynamic performance, enabled by the use of proprietary nickel-free Rhenium alloys developed by MiRus. These materials provided high strength, fatigue resistance, and minimal recoil, supporting improved device performance during transcatheter implantation procedures.<\/p>\n\n\n\n<p><em>&#8220;The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis,&#8221; said Pradeep K. Yadav, MD, National Co-Principal Investigator STAR Trial, &#8220;As TAVR has becomes standard of care across risk profiles, it is vital that we study the next generation of devices and techniques to minimize risks such as stroke, bleeding, pacemaker dependency and optimize valve longevity \u2013 especially in younger, lower-risk patients.&#8221;<\/em><\/p>\n\n\n\n<p><em>&#8220;Our initial experience is very positive,&#8221; commented Pradeep K. Yadav, MD. &#8220;Siegel is much less invasive then current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/transcatheter-heart-valve-replacement-devices-market\"><strong>Transcatheter Heart Valve Replacement Devices Market Report<\/strong><\/a>,\u201d&nbsp; the transcatheter heart valve replacement devices market is estimated to grow at a <strong>CAGR of 13.75%<\/strong> during the forecast period from 2024 to 2030. The transcatheter heart valve replacement 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 &amp; lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter heart valve replacement market during the forecast period from 2024 to 2030.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Waters Announced the FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay On 08 April 2026, Waters Corporation announced that the U.S. Food and Drug Administration had cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for 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