{"id":29459,"date":"2024-09-05T12:21:24","date_gmt":"2024-09-05T06:51:24","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=29459"},"modified":"2024-09-05T12:21:36","modified_gmt":"2024-09-05T06:51:36","slug":"medtech-news-of-pensar-medical-bd-haleon-embecta","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-of-pensar-medical-bd-haleon-embecta","title":{"rendered":"Pensar Medical\u2019s Partnership with Centurion Therapeutics; BD\u2019 Acquisition of Critical Care; Haleon\u2019s Launch of Eroxon; embecta Receives FDA Clearance; INFINITY-SWEDEHEART Trial of Elixir Medical\u2019s DynamX Bioadaptor; Median Technologies\u2019 Pivotal REALITY Study"},"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-69f4b8ab3beaf\" 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-69f4b8ab3beaf\"  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-of-pensar-medical-bd-haleon-embecta\/#Pensar_Medical_Entered_Into_a_Partnership_with_Centurion_Therapeutics_for_Innovative_Negative_Pressure_Wound_Therapy_System\" >Pensar Medical Entered Into a Partnership with Centurion Therapeutics for Innovative Negative Pressure Wound Therapy System&nbsp;<\/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-of-pensar-medical-bd-haleon-embecta\/#BD_Completed_Acquisition_of_Critical_Care_from_Edwards_Lifesciences\" >BD Completed Acquisition of Critical Care from Edwards Lifesciences<\/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-of-pensar-medical-bd-haleon-embecta\/#Haleon_Announced_the_Launch_of_Eroxon%C2%AE_the_First_and_Only_FDA_Cleared_OTC_Gel_for_Erectile_Dysfunction_Available_for_US_Preorder_Without_a_Prescription\" >Haleon Announced the Launch of Eroxon\u00ae, the First and Only FDA Cleared OTC Gel for Erectile Dysfunction, Available for U.S. Preorder Without a Prescription<\/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-of-pensar-medical-bd-haleon-embecta\/#embecta_Announced_the_FDA_Clearance_of_its_Disposable_Patch_Pump_for_Insulin_Delivery_Informed_by_Unique_Needs_of_People_with_Type_2_Diabetes\" >embecta Announced the FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by Unique Needs of People with Type 2 Diabetes<\/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-of-pensar-medical-bd-haleon-embecta\/#INFINITY-SWEDEHEART_Trial_of_Elixir_Medicals_DynamX_Bioadaptor_Met_Primary_Endpoint_and_Clinical_Results_Confirmed_Unique_Mechanism_of_Action\" >INFINITY-SWEDEHEART Trial of Elixir Medical\u2019s DynamX Bioadaptor Met Primary Endpoint and Clinical Results Confirmed Unique Mechanism of Action<\/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-of-pensar-medical-bd-haleon-embecta\/#Median_Technologies_Announced_Pivotal_REALITY_Study_of_its_eyonis%E2%84%A2_LCS_Lung_Cancer_Diagnostic_Met_All_Primary_and_Secondary_Endpoints\" >Median Technologies Announced Pivotal REALITY Study of its eyonis\u2122 LCS Lung Cancer Diagnostic Met All Primary and Secondary Endpoints<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-pensar-medical-entered-into-a-partnership-with-centurion-therapeutics-for-innovative-negative-pressure-wound-therapy-system-nbsp\"><span class=\"ez-toc-section\" id=\"Pensar_Medical_Entered_Into_a_Partnership_with_Centurion_Therapeutics_for_Innovative_Negative_Pressure_Wound_Therapy_System\"><\/span>Pensar Medical Entered Into a Partnership with Centurion Therapeutics for Innovative Negative Pressure Wound Therapy System&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> Aug 29, 2024, <\/strong>Pensar Medical, a pioneer in negative pressure wound therapy (NPWT), announced a strategic partnership with Centurion Therapeutics to distribute the Microdoc\u00ae sNPWT (single-use negative pressure wound therapy) platform. This collaboration is designed to improve patient care and broaden access to advanced wound management solutions. The Microdoc\u00ae sNPWT system provides an efficient and cost-effective solution for treating chronic and acute wounds. By merging Pensar Medical&#8217;s cutting-edge technology with Centurion Therapeutics&#8217; extensive distribution network, this partnership aims to accelerate the widespread adoption of the Microdoc\u00ae platform. The proven benefits of sNPWT will be delivered through over 500 sales professionals across more than 600 care sites.<\/p>\n\n\n\n<p>The annual market for sNPWT is valued at approximately USD 400 million and is expanding at a rate of over 20% each year. This growth is bolstered by clinical evidence showing that sNPWT can lower the incidence of surgical site infections and enhance healing outcomes. With surgical site infections costing the U.S. healthcare system more than USD 3.3 billion annually, sNPWT devices like MicroDoc\u00ae have the potential to reduce this risk by over 50%.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;We are thrilled to partner with Centurion Therapeutics<\/em>,<em>&#8220;<\/em> said&nbsp;Jason Bandy, CEO of Pensar Medical. <em>&#8220;Their strong presence and rapid growth in the inpatient market, combined with our novel NPWT technology, will enable us to reach more patients and improve outcomes.&#8221;<\/em><\/p>\n<\/blockquote>\n<\/blockquote>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Robert Goodwin, President and CEO of Centurion Therapeutics, affirmed, <em>&#8220;Adding the Microdoc\u00ae&nbsp;sNPWT system to our product portfolio aligns perfectly with our commitment to providing comprehensive wound and surgical management solutions nationwide. We are excited about the opportunity to offer this innovative product to our distribution partners and their customers.&#8221;<\/em><\/p>\n<\/blockquote>\n<\/blockquote>\n\n\n\n<p>As per DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/advanced-wound-care-market\"><strong>Advanced Wound Care Market Report<\/strong><\/a><strong>\u201d<\/strong>,<strong> <\/strong>the advanced wound care market was valued at&nbsp;<strong>USD 9.45 billion <\/strong>in 2023,&nbsp;growing at a<strong>&nbsp;CAGR <\/strong>of<strong> 10.51%&nbsp;<\/strong>during the forecast period from 2024 to 2030, to reach&nbsp;<strong>USD 16.97 billion <\/strong>by 2030. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players is expected to significantly drive the demand for advanced wound care from 2024 to 2030.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-bd-completed-acquisition-of-critical-care-from-edwards-lifesciences\"><span class=\"ez-toc-section\" id=\"BD_Completed_Acquisition_of_Critical_Care_from_Edwards_Lifesciences\"><\/span>BD Completed Acquisition of Critical Care from Edwards Lifesciences<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> September 03, 2024<\/strong>, BD (Becton, Dickinson, and Company), a global leader in medical technology, announced that it completed the acquisition of Edwards Lifesciences&#8217; Critical Care product group, which will now be rebranded as BD Advanced Patient Monitoring.&nbsp;<\/p>\n\n\n\n<p>BD Advanced Patient Monitoring is a global leader in advanced monitoring solutions, enhancing BD&#8217;s portfolio of smart connected care technologies with its expanding range of leading monitoring systems, advanced AI-driven clinical decision tools, and a strong innovation pipeline. BD Advanced Patient Monitoring&#8217;s technologies are frequently used alongside the BD Alaris\u2122 Infusion System in operating rooms and intensive care units. The integration of BD&#8217;s new advanced monitoring and existing infusion platforms opens up future innovation opportunities for closed-loop hemodynamic monitoring and IV fluid and medication administration, by leveraging combined company data and interoperability features.<\/p>\n\n\n\n<p>BD Advanced Patient Monitoring&#8217;s portfolio features the gold-standard Swan Ganz pulmonary artery catheter, minimally invasive sensors, non-invasive cuffs, tissue oximetry sensors, and monitors. These smart technologies are powered by advanced data analytics, incorporating machine learning and AI-based predictive and prescriptive algorithms to help clinicians gain deeper insights into current and future patient conditions and provide robust clinical decision-support tools.&nbsp;<\/p>\n\n\n\n<p>BD Advanced Patient Monitoring will function as a distinct business unit within BD&#8217;s Medical segment to support its smart connected care strategy, and it will continue to operate from its location in Irvine, California.<\/p>\n\n\n\n<p>According to DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/patient-monitoring-devices-market\"><strong>Patient Monitoring Devices Market Report<\/strong><\/a><strong>\u201d<\/strong>, the global patient monitoring devices market was valued at&nbsp;<a href=\"https:\/\/www.delveinsight.com\/sample-request\/patient-monitoring-devices-market\"><strong>USD 35.21 billion<\/strong><\/a>&nbsp;in 2023, growing at a&nbsp;<a href=\"https:\/\/www.delveinsight.com\/sample-request\/patient-monitoring-devices-market\"><strong>CAGR <\/strong>of<strong> 8.20%<\/strong><\/a>&nbsp;during the forecast period from 2024 to 2030, to reach&nbsp;<a href=\"https:\/\/www.delveinsight.com\/sample-request\/patient-monitoring-devices-market\"><strong>USD 56.46 billion<\/strong>&nbsp;<\/a>by 2030. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Additionally, the growing preferences for remote patient monitoring systems among patients and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period (2024-2030).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-haleon-announced-the-launch-of-eroxon-the-first-and-only-fda-cleared-otc-gel-for-erectile-dysfunction-available-for-u-s-preorder-without-a-prescription\"><span class=\"ez-toc-section\" id=\"Haleon_Announced_the_Launch_of_Eroxon%C2%AE_the_First_and_Only_FDA_Cleared_OTC_Gel_for_Erectile_Dysfunction_Available_for_US_Preorder_Without_a_Prescription\"><\/span>Haleon Announced the Launch of Eroxon\u00ae, the First and Only FDA Cleared OTC Gel for Erectile Dysfunction, Available for U.S. Preorder Without a Prescription<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> September 03, 2024<\/strong>, Eroxon\u00ae, the first and only FDA-cleared gel for the treatment of erectile dysfunction (ED) available without a prescription, is now available for pre-order in the United States through Amazon and will be available at most major retailers starting in October 2024.&nbsp;<\/p>\n\n\n\n<p>Eroxon\u00ae is clinically proven to help men achieve an erection within 10 minutes to enhance physical intimacy (individual results may vary). The treatment works by stimulating nerve endings in the penis, aiding men with ED in attaining and maintaining an erection during sex. Unlike some prescription solutions that may take up to an hour to be effective, Eroxon\u00ae addresses a significant unmet need for men dealing with erectile dysfunction.<\/p>\n\n\n\n<p>Clinical study results demonstrate that Eroxon\u00ae is both safe and effective for men with erectile dysfunction (ED). Although ED can stem from underlying physical conditions, psychological factors such as stress, anxiety, depression, and other mental health issues can also play a role, particularly in younger men. Eroxon\u00ae is designed to help men with ED improve intimacy and connection in their relationships, promoting closer and more fulfilling partnerships.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Lisa Paley, President,&nbsp;North America&nbsp;at Haleon,&nbsp;said,&nbsp;<em>&#8220;At Haleon, we have a clear purpose to deliver better everyday health with humanity. Introducing Eroxon to U.S. consumers reflects our belief that sexual health is a critical part of wellness. We understand how important making meaningful and intimate connections are to one&#8217;s wellbeing, and Eroxon helps achieve just that. We are proud to take this bold step to make this first-of-its-kind over-the-counter (OTC) gel treatment accessible to the millions of men in the U.S. who are affected by ED.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Gerald Brock, MD, FRCSC, Haleon Partner,&nbsp;said,<em>&#8220;The body of scientific evidence for Eroxon supports it as an effective, fast-acting, and accessible OTC ED treatment with an excellent safety profile.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>As per DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/erectile-dysfunction-devices-market\"><strong>Erectile Dysfunction Devices<\/strong>&nbsp;<strong>Market Report<\/strong><\/a><strong>\u201d<\/strong>, the global erectile dysfunction devices market was valued at&nbsp;<strong>USD 1.77 billion&nbsp;<\/strong>in 2023, growing at a&nbsp;<strong>CAGR <\/strong>of <strong>9.46%<\/strong>&nbsp;during the forecast period from 2024 to 2030, to reach&nbsp;<strong>USD 1.77 billion<\/strong>&nbsp;by 2030. The erectile dysfunction devices market is expected to witness significant growth owing to the growing cases of erectile dysfunction, increase in the geriatric population of men, sedentary lifestyle that involves smoking, alcohol consumption, obesity, and technological advancements among erectile dysfunction devices product development from 2024-2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-embecta-announced-the-fda-clearance-of-its-disposable-patch-pump-for-insulin-delivery-informed-by-unique-needs-of-people-with-type-2-diabetes\"><span class=\"ez-toc-section\" id=\"embecta_Announced_the_FDA_Clearance_of_its_Disposable_Patch_Pump_for_Insulin_Delivery_Informed_by_Unique_Needs_of_People_with_Type_2_Diabetes\"><\/span>embecta Announced the FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by Unique Needs of People with Type 2 Diabetes<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> September 03, 2024, <\/strong>Embecta Corp., a global leader in diabetes care with a century-long history in insulin delivery, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary disposable insulin delivery system. Designed for adults with diabetes, including both type 1 (T1D) and type 2 (T2D), this system features a tubeless patch pump with a 300-unit insulin reservoir. The design was developed based on feedback from individuals with T2D and their healthcare providers.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201c<em>FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes<\/em>,\u201d said Dev Kurdikar, CEO. \u201c<em>As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development<\/em>.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>The system includes a wearable, fully disposable patch pump that delivers adjustable basal and bolus insulin for up to three days, based on the user&#8217;s needs. It features a 300-unit insulin reservoir, which is particularly suited for individuals with higher daily insulin requirements, commonly seen in people with type 2 diabetes (T2D). Traditional patch pumps may not have sufficient capacity for a three-day duration for these individuals. For instance, a recent study sponsored by embecta revealed that a 300-unit insulin reservoir could meet the needs of 64% of adults with T2D for a three-day period, compared to only 38% of those who would be adequately served by a 200-unit reservoir.<\/p>\n\n\n\n<p>The system also includes a secure controller equipped with Bluetooth\u00ae wireless technology and a color touchscreen, designed to offer a streamlined interface and enhance the overall user experience.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cOur research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this project from concept to clearance with dedication and diligence,\u201d <\/em>said Dr. Colleen Riley, Chief Technology Officer.<em> \u201cI want to thank the embecta team for their commitment to serving people with diabetes and thank the FDA for their timely review and clearance of a system that has the potential to reduce the burden of managing diabetes for more people and significantly move innovation in this area forward.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>As per DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/transdermal-drug-delivery-devices-market\"><strong>Transdermal Drug Delivery Devices Market Report<\/strong><\/a><strong>\u201d<\/strong>, the global transdermal drug delivery devices market is growing at a&nbsp;<strong>CAGR <\/strong>of<strong> 9.8%<\/strong>&nbsp;during the forecast period from 2024 to 2030. The demand for transdermal drug delivery devices is primarily witnessing growth on account of the increasing prevalence of chronic conditions, increase in adoption of third-generation transdermal drug delivery devices, technological advancements observed in the device, and the use of these devices from hormonal disorders to cardiovascular conditions and pain management.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-infinity-swedeheart-trial-of-elixir-medical-s-dynamx-bioadaptor-met-primary-endpoint-and-clinical-results-confirmed-unique-mechanism-of-action\"><span class=\"ez-toc-section\" id=\"INFINITY-SWEDEHEART_Trial_of_Elixir_Medicals_DynamX_Bioadaptor_Met_Primary_Endpoint_and_Clinical_Results_Confirmed_Unique_Mechanism_of_Action\"><\/span>INFINITY-SWEDEHEART Trial of Elixir Medical\u2019s DynamX Bioadaptor Met Primary Endpoint and Clinical Results Confirmed Unique Mechanism of Action<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> September 02, 2024<\/strong>, a developer of groundbreaking technologies for treating cardiovascular disease announced that the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) comparing the novel DynamX\u00ae Coronary Bioadaptor System with the contemporary Resolute Onyx\u2122 zotarolimus drug-eluting stent (DES) achieved its primary endpoint of non-inferiority for target lesion failure (TLF) (2.35% versus 2.77%; p&lt;0.001) at 12 months. The results were presented in a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress 2024 in London.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201c<em>The DynamX bio-adaptor represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action six months following the percutaneous coronary intervention (PCI) procedure<\/em>,\u201d said principal investigator David Erlinge, M.D., Ph.D., and head of the Cardiology Department at Lund University, Lund, Sweden. \u201c<em>Each year millions of patients undergo PCI globally, and while a very safe procedure, the implantation of stents has been associated with an annual recurring adverse event rate. Sustained reduction and plateauing of these recurring adverse clinical events would create a major benefit over the lifetime of a patient<\/em>.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>Clinical results from the 2,400-patient INFINITY-SWEDEHEART study demonstrated:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>TLF of 2.35% versus 2.77% met non-inferiority (p&lt;0.001) at 12 months for DynamX bioadaptor and Resolute Onyx DES, respectively. The low TLF with DynamX was driven by numerically low adverse events across components of the composite endpoint with DynamX compared to Resolute Onyx DES, respectively:<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Target vessel myocardial infarction (TV-MI) (1.27% versus 1.52%)<\/li>\n\n\n\n<li>Ischemia-driven target lesion revascularization (ID-TLR) (1.27% versus 2.11%)<\/li>\n\n\n\n<li>Cardiovascular death (0.59% versus 0.50%)<\/li>\n\n\n\n<li>Target vessel failure (TVF) at 12 months was also lower at 3.03% versus 3.52%, for DynamX compared to DES, respectively.<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe results of our trial strongly support the clinical impact of the Bio-adaptor in coronary artery disease treatment, with a potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,\u201d <\/em>said study chair Stefan James, M.D., Ph.D., and Professor of Cardiology at Uppsala University, Sweden<em>. \u201cThe Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The DynamX bio-adaptor had recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation is for its use in enhancing coronary luminal diameter, restoring hemodynamic function, and slowing plaque progression in patients with symptomatic ischemic heart disease caused by discrete new native coronary artery lesions. The bio-adaptor employs an innovative mechanism of action, working through three distinct phases to improve vessel health and return vessel biology to a more normal state.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cResults from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we\u2019ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies \u2013 consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months,\u201d <\/em>said Motasim Sirhan, CEO of Elixir Medical<em>. \u201cWe are thrilled by the results from the landmark analysis data after six months showing statistically significant reduction in TLF and TVF versus DES. As an innovation-driven company, these data further validate the bioadaptor\u2019s unique mechanism of action and its advantage in treating coronary artery disease to improve the standard of care for our patients\u201d.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>According to DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/drug-eluting-stents-market\"><strong>Drug-Eluting Stents Market Report<\/strong><\/a>\u201d, the global drug-eluting stents market was valued at&nbsp;<strong>USD 2.57 billion<\/strong>&nbsp;in 2023, growing at a&nbsp;<strong>CAGR <\/strong>of<strong> 8.09%<\/strong>&nbsp;during the forecast period from 2024 to 2030 to reach&nbsp;<strong>USD 4.08 billion&nbsp;<\/strong>by 2030. The drug-eluting stents market is slated to witness prosperity owing to factors such as the growing prevalence of cardiovascular diseases which can further be attributed to the increase in the geriatric population wherein aging is considered to have a deleterious effect on blood vessels, growing prevalence of lifestyle disorders such as hypertension, diabetes, and obesity that are linked to affect the health of blood vessels in long term and drastically increase the probability of atherosclerosis, and the growing focus on developing a newer generation of drug-eluting stents to minimize post-procedural complications are further expected to result in the appreciable revenue growth in the drug-eluting stents market during the forecast period (2024-2030).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-median-technologies-announced-pivotal-reality-study-of-its-eyonis-lcs-lung-cancer-diagnostic-met-all-primary-and-secondary-endpoints\"><span class=\"ez-toc-section\" id=\"Median_Technologies_Announced_Pivotal_REALITY_Study_of_its_eyonis%E2%84%A2_LCS_Lung_Cancer_Diagnostic_Met_All_Primary_and_Secondary_Endpoints\"><\/span>Median Technologies Announced Pivotal REALITY Study of its eyonis\u2122 LCS Lung Cancer Diagnostic Met All Primary and Secondary Endpoints<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> August 29, 2024, <\/strong>Median Technologies announced that its proprietary Artificial Intelligence (AI)\/machine learning (ML) powered software, eyonis\u2122 LCS, designed for lung cancer screening (LCS), successfully achieved the primary and all secondary endpoints in REALITY. This is the first of two pivotal studies needed for marketing authorizations in the U.S. and Europe.<\/p>\n\n\n\n<p>Median\u2019s eyonis\u2122 LCS SaMD is intended to enhance the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the global standard of care and is currently the only approved method for lung cancer screening in the U.S. and Europe.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Fredrik Brag, CEO of Median Technologies said, <em>\u201cThese data met our ambition for improving the performance of LDCT with eyonis\u2122 LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis\u2122 LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The average five-year survival rate for lung cancer patients is 18.6 percent, primarily because only 16 percent of lung cancers are identified at an early stage. In contrast, Stage 1 lung cancer, if detected early, has a high cure rate, with an 80% survival rate after 20 years, often due to deaths from other causes. For Stage 1A cancers that are 10 mm or smaller, the 20-year survival rate is as high as 92%.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Thomas Bonnefont, COO and CCO eyonis\u2122 Business Unit said,<em>&nbsp;\u201cThe high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The definitive results from REALITY demonstrate that eyonis\u2122 LCS can accurately detect and characterize cancerous nodules. The novel SaMD delivered outstanding performance, achieving an area under the curve (AUC) of 0.904 at the patient level, significantly exceeding the AUC of 0.80, which was the minimum primary endpoint for REALITY. Notably, 80% of the cancers in the REALITY cohort were challenging Stage 1 cases. Additionally, the REALITY cohort included a higher proportion of small non-spiculated cancers and large spiculated benign nodules\u2014both of which present diagnostic challenges for radiologists.<\/p>\n\n\n\n<p>The pivotal REALITY study, which began in July 2023, gathered retrospective imaging and clinical data from 1,147 patients across five major cancer centers and hospitals in the U.S. and Europe, as well as two clinical data providers. This study evaluated the capability of eyonis\u2122 LCS to diagnose lung cancer. Its objectives were to assess the standalone performance of eyonis\u2122 LCS in distinguishing between cancerous and non-cancerous patients (i.e., &#8220;performance at patient level&#8221;) and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint, established in consultation with U.S. regulatory authorities, was set to demonstrate that eyonis\u2122 LCS would achieve an AUC greater than 0.8.<\/p>\n\n\n\n<p>According to DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/drug-eluting-stents-market\"><strong>Cancer Diagnostics Market Report<\/strong><\/a><strong>\u201d,<\/strong> the global cancer diagnostics market was valued at&nbsp;<strong>USD 125.13 billion<\/strong>&nbsp;in 2023, growing at a&nbsp;<a href=\"https:\/\/www.delveinsight.com\/sample-request\/cancer-diagnostic-market\"><strong>CAGR <\/strong>of<strong> 9.43%<\/strong><\/a>&nbsp;during the forecast period from 2024 to 2030, to reach&nbsp;<strong>USD 214.88 billion<\/strong>&nbsp;by 2030. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, the growing manufacturers&#8217; focus on developing advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pensar Medical Entered Into a Partnership with Centurion Therapeutics for Innovative Negative Pressure Wound Therapy System&nbsp; On Aug 29, 2024, Pensar Medical, a pioneer in negative pressure wound therapy (NPWT), announced a strategic partnership with Centurion Therapeutics to distribute the Microdoc\u00ae sNPWT (single-use negative pressure wound therapy) platform. This collaboration is designed to improve patient [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":29462,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[19491,19154,19055,19387,22234,2753,17021,16975,19790,19789,22260],"industry":[17226],"therapeutic_areas":[17557,17228],"class_list":["post-29459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-advanced-wound-care","tag-cancer-diagnostics","tag-drug-eluting-stents","tag-drug-eluting-stents-market","tag-erectile-dysfunction-devices","tag-medical-device","tag-medical-devices-market","tag-medtech-market","tag-patient-monitoring-devices","tag-patient-monitoring-devices-market","tag-transdermal-drug-delivery-devices","industry-medical-devices","therapeutic_areas-male-health","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MedTech News | Pensar Medical, BD, Haleon, embecta<\/title>\n<meta name=\"description\" content=\"Pensar Medical\u2019s Centurion Therapeutics Partnership; BD\u2019s Edwards Lifesciences Acquisition; Haleon\u2019s Eroxon; embecta\u2019s Disposable Patch Pump\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-of-pensar-medical-bd-haleon-embecta\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News | Pensar Medical, BD, Haleon, embecta\" \/>\n<meta property=\"og:description\" content=\"Pensar Medical\u2019s Centurion Therapeutics Partnership; BD\u2019s Edwards Lifesciences Acquisition; Haleon\u2019s Eroxon; embecta\u2019s Disposable Patch Pump\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-of-pensar-medical-bd-haleon-embecta\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-05T06:51:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-09-05T06:51:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/09\/05122103\/medtech-news-of-pensar-medical-bd-haleon-embecta.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" 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