{"id":15965,"date":"2022-02-10T18:16:24","date_gmt":"2022-02-10T12:46:24","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=15965"},"modified":"2022-03-10T10:27:55","modified_gmt":"2022-03-10T04:57:55","slug":"medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","title":{"rendered":"Stryker\u2019s Tornier Shoulder Arthroplasty; Genesis Acquires JC Medical; FDA Clearance to Single-Use Gastroscope; BioCardia\u2019s CardiAMP Cell Therapy System; Abbott\u2019s Dual-Chamber Leadless Pacemaker; atHeart\u2019s ASCENT ASD U.S. IDE"},"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-6a02b25beaaa0\" 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-6a02b25beaaa0\"  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-stryker-genesis-ambu-biocardia-abbott-atheart\/#BioCardia_Receives_FDA_Breakthrough_Device_Designation_for_CardiAMP_Cell_Therapy_System_for_Heart_Failure\" >BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure<\/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-stryker-genesis-ambu-biocardia-abbott-atheart\/#Stryker_Introduces_Tornier_Shoulder_Arthroplasty_Portfolio_and_Launches_New_Tornier_Perform_Humeral_System_in_Europe\" >Stryker Introduces Tornier Shoulder Arthroplasty Portfolio and Launches New Tornier Perform Humeral System in Europe<\/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-stryker-genesis-ambu-biocardia-abbott-atheart\/#Genesis_MedTech_Acquires_JC_Medical_Creates_New_Structural_Heart_Franchise\" >Genesis MedTech Acquires JC Medical, Creates New Structural Heart Franchise<\/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-stryker-genesis-ambu-biocardia-abbott-atheart\/#Ambu_Announces_FDA_Clearance_of_Single-Use_Gastroscope_and_Next-Generation_Display_Unit\" >Ambu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit<\/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-stryker-genesis-ambu-biocardia-abbott-atheart\/#Abbott_Announces_Worlds_First_Implant_of_Dual-Chamber_Leadless_Pacemaker_in_Pivotal_Trial\" >Abbott Announces World&#8217;s First Implant of Dual-Chamber Leadless Pacemaker in Pivotal Trial<\/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-stryker-genesis-ambu-biocardia-abbott-atheart\/#atHeart_Medical_Receives_FDA_Approval_for_the_Second_Phase_of_the_ASCENT_ASD_US_IDE_Trial\" >atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-biocardia-receives-fda-breakthrough-device-designation-for-cardiamp-cell-therapy-system-for-heart-failure\"><span class=\"ez-toc-section\" id=\"BioCardia_Receives_FDA_Breakthrough_Device_Designation_for_CardiAMP_Cell_Therapy_System_for_Heart_Failure\"><\/span><strong>BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>February 03, 2022<\/strong>, The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP\u00ae Cell Therapy System for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-heart-failure-ahf-pipeline-insight\">treatment of heart failure<\/a>, according to BioCardia\u00ae, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. It was thought to be the first cardiac cell therapy to be designated as a Breakthrough Device by the FDA.<\/p>\n\n\n\n<p>Carl Pepine, MD, MACC, Professor in the Division of Cardiovascular Medicine at the University of Florida said, <em>\u201cIt is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the U.S. pivotal trial of the CardiAMP Cell Therapy to build the body of evidence necessary to support this accelerated FDA path&#8221;<\/em><\/p>\n\n\n\n<p>Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia said,<em> \u201cWe thank the FDA for granting Breakthrough Device Designation to the CardiAMP Cell Therapy System and recognizing its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy. The published results from our clinical trials to date have met our high expectations in showing the therapy\u2019s ability to address the loss of heart function in ischemic heart failure. We look forward to completing our Phase III trial and engaging with the FDA as we move closer to the prospect of benefiting patients whose lives are severely impacted by this disease.\u201d<\/em><\/p>\n\n\n\n<p>The CardiAMP Cell Therapy Heart Failure Trial was a crucial trial in the United States that was recruiting patients to see if the CardiAMP Cell Therapy System may improve patient survival, reduce significant adverse cardiac events, improve functional capacity, and improve quality of life. On February 8, 2022, the trial was subjected to a predetermined official Data Safety Monitoring Board Review, which would examine the trial&#8217;s safety and futility. The results of this evaluation should be accessible within a few days after its completion.<\/p>\n\n\n\n<p>According to<strong> <\/strong>DelveInsight\u2019s \u2018Congestive Heart Failure Treatment Devices &#8211; Market Insight, Competitive Landscape and Market Forecast, 2026\u201d,<strong> <\/strong>as per CDC 2020 statistics, about 6.2 million adults in the United States have heart failure in 2020. Moreover, in 2018, heart failure was mentioned on 379,800 death certificates (13.4%) in the US. Therefore, rise in cases of heartfailure will prove to be a driving factor for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/congestive-heart-failure-treatment-devices-market\">Congestive Heart Failure Treatment Devices market<\/a> during the forecast period.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Stryker_Introduces_Tornier_Shoulder_Arthroplasty_Portfolio_and_Launches_New_Tornier_Perform_Humeral_System_in_Europe\"><\/span><strong>Stryker Introduces Tornier Shoulder Arthroplasty Portfolio and Launches New Tornier Perform Humeral System in Europe<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> February 03, 2022, <\/strong><a href=\"https:\/\/www.stryker.com\/us\/en\/index.html\">Stryker<\/a>, one of the world&#8217;s top medical technology firms, officially launched the Tornier shoulder arthroplasty portfolio in Europe, with the Perform Humeral Stem as the first new Tornier product.<\/p>\n\n\n\n<p>The new Tornier Perform Humeral Stem, which was supported by Blueprint planning software and the Tornier Perform Anatomic and Reverse Glenoid, provided clinical solutions for a range of basic to difficult shoulder arthroplasty cases. It&#8217;s designed for shoulder anatomic, reverse, and hemiarthroplasty procedures. In the event of revision, it also allowed for the conversion of an anatomic to a reverse shoulder prosthesis.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The Tornier Perform Humeral Stem was created with four collar diameters and varying lengths in mind to enhance humeral fit and provide surgeons the power to perform while also giving them alternatives. Because of the emphasis on smaller stem alternatives, it&#8217;s great for dealing with tiny patient anatomies that provide specific problems.<\/li><li>To accommodate the patient&#8217;s unique anatomy, the Tornier Perform Humeral Stem is compatible with the entire array of standard and augmented Perform glenoid options\u2014for anatomic and reversing surgeries.<\/li><li>Blueprint<sup>TM<\/sup> planning software enabled surgeons to plan their Perform cases advance and gives real-time, precise virtual surgery for increased confidence before entering the operating room.<\/li><\/ul>\n\n\n\n<p>Dr. Gilles Walch, Lyon, FR, one of the designers of the system said,<em> \u201cThe Tornier Perform Humeral Stem gives the ability to use Blueprint to confirm surgical plans and optimize the full range of glenoid options available. With Perform, surgeons are better able to address the needs of both highly complex and simple patient cases.\u201d<\/em><\/p>\n\n\n\n<p>According to<strong> <\/strong>DelveInsight\u2019s &#8220;<a href=\"https:\/\/www.delveinsight.com\/report-store\/shoulder-replacement-devices-market\">Shoulder Replacement Devices Market<\/a>\u201d<strong> <\/strong>Report<strong>, <\/strong>the global market was valued at USD 1.68 billion in 2020, growing at a CAGR of 7.27% during the forecast period from 2021 to 2026, to reach USD 2.54 billion by 2026. The demand for Shoulder Replacement Devices is primarily attributed to the rapid success rate and increase in the number of surgeries due to advancements in technology, the rising popularity of reverse total shoulder arthroplasty for rotator cuff arthropathy in the growing geriatric population due to the widespread occurrence of bone-related disorders, the prevalence of sports injuries and accidents, and growing medical infrastructure and medical facilities. Moreover, the growing life expectancy for the population and increasing cases of arthritis due to a sedentary lifestyle are the key reasons responsible for the development of the Shoulder Replacement Devices market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Genesis_MedTech_Acquires_JC_Medical_Creates_New_Structural_Heart_Franchise\"><\/span><strong>Genesis MedTech Acquires JC Medical, Creates New Structural Heart Franchise<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> February 04, 2022, <\/strong>Genesis MedTech Group finalized the purchase of JC Medical (JCM), a structural heart firm specializing in the design and development of transcatheter valve replacement technologies for minimally invasive structural heart disease therapy. Genesis added J-Valve, a minimally invasive <a href=\"https:\/\/www.delveinsight.com\/report-store\/transcatheter-aortic-valve-replacement-market\">transcatheter aortic valve replacement (TAVR) device<\/a> for patients with aortic regurgitation and <a href=\"https:\/\/www.delveinsight.com\/report-store\/aortic-stenosis-market\">stenosis<\/a>, to its product line as a result of the purchase. This addition significantly enhanced Group&#8217;s capacity to better serve patients, interventional cardiologists, and cardiac surgeons.<\/p>\n\n\n\n<p>J-Valve, created by JCM, is one of only two firms in the world to have successfully developed and commercialized a minimally invasive TAVR device approved for both aortic regurgitation and stenosis patients, and the first and only in China.&nbsp;<\/p>\n\n\n\n<p>On the leadership front, Zhang Ji, the Founder and President of JCM, continued to oversee the company. He would also serve as the Chief Technology Officer for Genesis&#8217; Structural Heart Franchise, utilizing his experience and skills to drive new product development and innovation.<\/p>\n\n\n\n<p>Warren Wang, Chairman, and CEO of Genesis MedTech Group said, <em>&#8220;The acquisition of JCM and J-Valve exemplifies the type of innovations we envisage as part of a growing Genesis portfolio. We are incredibly pleased to start a new Structural Heart Franchise, spearheaded by the best-in-class TAVR solution, J-Valve. By doing this we hope to better support cardiac surgeons and cardiologists in their fight against structural heart diseases.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s &#8220;<a href=\"https:\/\/www.delveinsight.com\/report-store\/structural-heart-devices-market-market\">Structural Heart Devices Market<\/a>\u201d Report<strong>, <\/strong>the global market was valued at USD 8.82 billion in 2020, growing at a CAGR of 11.23% during the forecast period from 2021 to 2026 to reach USD 16.70 billion by 2026. The demand for structural heart devices is primarily being boosted by the rapid growth in the prevalence of structural heart diseases, growing popularity of minimally invasive interventions, increase in the research and development activities in product development, the approval of new and advanced products, and the inclusion of structural heart devices in various reimbursement &amp; insurance programs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ambu_Announces_FDA_Clearance_of_Single-Use_Gastroscope_and_Next-Generation_Display_Unit\"><\/span><strong>Ambu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> February 04, 2022,<\/strong> The Ambu\u00ae aScope<sup>TM<\/sup> Gastro and Ambu\u00ae aBox<sup>TM<\/sup> 2 received 510(k) regulatory approval in the United States, as per Ambu A\/S. Ambu&#8217;s first sterile single-use gastroscope, the aScope Gastro, incorporated new superior imaging and design characteristics in a combined solution with next-generation display and processing technologies. The aBox 2 established a new standard in picture quality with its HD capabilities, and it was the heart of Ambu&#8217;s <a href=\"https:\/\/www.delveinsight.com\/report-store\/endoscopic-ultrasound-market\">endoscopic ecosystem<\/a>.<\/p>\n\n\n\n<p>Ambu&#8217;s solution addresses the current limitations of reusable endoscopes with advanced technology, mobility, and cost-effectiveness, and it will be an appealing alternative for clients wishing to perform gastroscopies in a variety of care settings (including endoscopy unit, OR, ICU, ER, ASC). Furthermore, the aScope Gastro will assist healthcare systems in their attempts to minimize wait times and address personnel shortages, both of which have become more acute since the outbreak of COVID-19. Finally, the sterile offering addresses the rising danger of cross-contamination, which is especially concerning for sensitive patients.<\/p>\n\n\n\n<p>Prof. Pradeep Bhandari, Queen Alexandra Hospital, Portsmouth, UK said <em>\u201cThe Ambu system comes at a time where we\u2019re dealing with waiting lists and staff shortages, and where the ease of setup and elimination of reprocessing, are major advantages. Also, the combination of a sterile single-use gastroscope and a compact display unit opens up the opportunity to expand endoscopy to alternative settings, such as Intensive Care Units.&#8221;&nbsp;<\/em><\/p>\n\n\n\n<p>Reginald Bell, M.D., F.A.C.S, Institute of Esophageal and Reflux Surgery, Lone Tree, Colorado, USA, said<em> \u201cIn the OR setting, having a single-use scope that is immediately available with a small footprint, which requires much less up-front capital outlay than a reusable setup, will be valuable to many hospitals across the country.\u201d<\/em>&nbsp;<\/p>\n\n\n\n<p>Ambu would proceed with the commercialization of the aScope Gastro and aBox 2 in the United States since the FDA has given its approval.<\/p>\n\n\n\n<p>According to<strong> <\/strong>DelveInsight\u2019s &#8220;<a href=\"https:\/\/www.delveinsight.com\/report-store\/gastroendoscopes-market\">Gastroendoscopes Market<\/a>\u201d<strong> <\/strong>Report<strong>, <\/strong>the global Gastroendoscopes<strong> <\/strong>market was valued at USD 3.08 billion in 2020, growing at a CAGR of 6.69% during the forecast period from 2021 to 2026 to reach USD 4.53 billion by 2026. The Gastroendoscopes market is witnessing a positive market growth owing to the factors such as the increasing prevalence of various Gastrointestinal diseases such as <a href=\"https:\/\/www.delveinsight.com\/report-store\/gastroesophageal-reflux-disease-gerd-treatment-devices-market\">gastro-oesophageal reflux disease (GORD)<\/a>, growing prevalence of stomach cancer and <a href=\"https:\/\/www.delveinsight.com\/report-store\/esophageal-cancer-market\">oesophageal cancer<\/a>, rising cases of gastrointestinal procedures among the geriatric population, and rapid product development activities with respect to Gastroendoscopes among others.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Abbott_Announces_Worlds_First_Implant_of_Dual-Chamber_Leadless_Pacemaker_in_Pivotal_Trial\"><\/span><strong>Abbott Announces World&#8217;s First Implant of Dual-Chamber Leadless Pacemaker in Pivotal Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> February 07, 2022,<\/strong> As part of its AVEIR DR i2i<sup>TM<\/sup> pivotal clinical research, <a href=\"https:\/\/abbott.mediaroom.com\/2022-02-07-Abbott-Announces-Worlds-First-Implant-of-Dual-Chamber-Leadless-Pacemaker-in-Pivotal-Trial\">Abbott<\/a>&nbsp;announced the world&#8217;s first patient implantation of a dual-chamber leadless pacemaker device. The first patient in the pivotal study to receive Abbott&#8217;s experimental Aveir<sup>TM<\/sup> dual-chamber leadless pacemaker represented a significant technological milestone for leadless pacing technology.<\/p>\n\n\n\n<p>Daniel J. Cantillon, M.D., clinical trial steering committee co-chair and Associate Section Head and Research Director of Cardiac Electrophysiology and Pacing, Cleveland Clinic, and Reinoud Knops, M.D., Ph.D., clinical trial steering committee co-chair and Department of Cardiology and Electrophysiology, Amsterdam University Medical Center, The Netherlands, co-chaired the study.&nbsp;<\/p>\n\n\n\n<p>Abbott overcame the obstacle of synchronization of two leadless pacemakers by developing the company&#8217;s groundbreaking &#8220;i2i technology,&#8221; which allowed two leadless pacemakers, one in the right ventricle and the other in the right atrium, to communicate beat-by-beat. This method allowed for genuine dual-chamber leadless pacing by regulating the heart rate synchronously between chambers.<\/p>\n\n\n\n<p>The first implant was performed at Na Homolce Hospital in Prague, the Czech Republic, led by site principal investigator Petr Neuzil, M.D., Ph.D., Head of the Department of Cardiology, and assisted by site co-investigator, Vivek Y. Reddy, M.D.<\/p>\n\n\n\n<p>Dr. Daniel J. Cantillon said,<em> &#8220;The first-in-human implant of a dual-chamber leadless pacemaker is a major clinical milestone that will open up new possibilities for patients requiring pacing support. Abbott has designed a device capable of treating these patients, and we&#8217;re excited to see this technology advance patient care.&#8221;<\/em><\/p>\n\n\n\n<p>Randel Woodgrift, senior vice president of Abbott&#8217;s cardiac rhythm management business, said<em> &#8220;The Aveir DR dual-chamber leadless pacemaker builds upon our Aveir VR single-chamber leadless platform, and we believe that once approved these systems have the potential to change the way doctors approach the treatment of abnormal heart rhythms. The involvement of world-class heart institutions in this study reinforces that the innovations we are developing are exactly the kind of advancements physicians around the world want for their patients.&#8221;<\/em><\/p>\n\n\n\n<p>According to<strong> <\/strong>DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/pacemakers-market\">Pacemakers Market<\/a>\u201d Report<strong>, <\/strong>the <a href=\"https:\/\/www.delveinsight.com\/report-store\/pacemakers-pipeline-insight-and-competitive-landscape\">global Pacemakers market<\/a> was valued at USD 4.63 billion in 2020, growing at a CAGR of 5.81% during the forecast period from 2021 to 2026, to reach USD 5.78 billion by 2026. The demand for Pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"atHeart_Medical_Receives_FDA_Approval_for_the_Second_Phase_of_the_ASCENT_ASD_US_IDE_Trial\"><\/span><strong>atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> February 08, 2022, <\/strong><a href=\"https:\/\/atheartmedical.com\/fda-approved-second-phase-of-ascent-asd\/\">atHeart Medical<\/a>, a medical device company devoted to creating a new standard of care for the closure of atrial septal defects (ASD) announced that the second phase of its ASCENT ASD US Investigational Device Exemption (IDE) pivotal study has been approved.<\/p>\n\n\n\n<p>The reSept<sup>TM<\/sup> ASD Occluder, the first occluder with a metal-free, bioresorbable frame, was being tested in prospective, single-arm research to determine its safety and efficacy in the treatment of individuals with clinically significant, isolated ASDs. The primary outcomes would be compared to previously FDA-approved transcatheter ASD occluders&#8217; performance targets.<\/p>\n\n\n\n<p>The reSept ASD Occluder intended to solve the constraints of conventional occluders, which include metallic frames, which might put patients at risk of issues associated with long-term metal exposure in the heart and may limit future transseptal operations, such as mitral valve surgery. The company&#8217;s product has shown to be safe and effective in the closure of ASDs in the early stages of clinical trials.<\/p>\n\n\n\n<p>Laurent Grandidier, CEO of atHeart Medical said, <em>\u201cI am pleased the first phase of enrollment in our pivotal trial progressed smoothly and according to plan, this is an exciting milestone for the company. As we initiate the second phase, our team is focused on adding clinical sites across the US and expanding internationally to include several enrolling sites in France. I commend the team\u2019s diligence to further validating the safety and efficacy of the reSept ASD Occluder, a critical step in our journey to evolve septal closure and provide a better solution for patients.\u201d<\/em><\/p>\n\n\n\n<p>Dr. Scott Lim, Professor of Medicine &amp; Pediatrics at the University of Virginia in Charlottesville, VA and a leading enrolling site in the trial commented,<em> \u201cThe low-profile reSept Occluder is a dynamic system that allows for versatile physician control during the intervention, potentially adapting to the different patient anatomies to address ASDs. \u201cOver time, reSept\u2019s metal-free frame resorbs, leaving a minimal implant behind. This is an exciting advancement that provides the potential to preserve future treatment options and potentially do better for our patients.\u201d<\/em>According to DelveInsight\u2019s &#8220;<a href=\"https:\/\/www.delveinsight.com\/report-store\/congenital-heart-defect-devices-market\">Congenital Heart Defect Devices Market<\/a>&#8220;<strong> <\/strong>Report, Medtronic Plc., Boston Scientific Corporation, St. Jude Medical, Inc., among others are the key players operating in the Congenital Heart Defect Devices market.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure On February 03, 2022, The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP\u00ae Cell Therapy System for the treatment of heart failure, according to BioCardia\u00ae, Inc., a developer of cellular and cell-derived therapeutics for the [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":15979,"comment_status":"open","ping_status":"open","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":[19084,17320,19086,2753,16975,18799,420,19085,19087,16929],"industry":[17226],"therapeutic_areas":[17242,17239,17228],"class_list":["post-15965","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-congenital-heart-defect-devices","tag-esophageal-cancer","tag-gastroendoscopes","tag-medical-device","tag-medtech-market","tag-medtech-news","tag-news","tag-pacemakers-market","tag-structural-heart-devices","tag-transcatheter-aortic-valve-replacement","industry-medical-devices","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-gastroenterology","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>Latest MedTech Updates | Stryker Genesis Ambu BioCardia Abbott atHeart<\/title>\n<meta name=\"description\" content=\"FDA Clearance to Single-Use Gastroscope; Stryker\u2019s Tornier Shoulder Arthroplasty; Abbott\u2019s Dual-Chamber Leadless Pacemaker; Genesis Acquires\" \/>\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-for-stryker-genesis-ambu-biocardia-abbott-atheart\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Latest MedTech Updates | Stryker Genesis Ambu BioCardia Abbott atHeart\" \/>\n<meta property=\"og:description\" content=\"FDA Clearance to Single-Use Gastroscope; Stryker\u2019s Tornier Shoulder Arthroplasty; Abbott\u2019s Dual-Chamber Leadless Pacemaker; Genesis Acquires\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart\" \/>\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=\"2022-02-10T12:46:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-03-10T04:57:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart.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=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"11 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Latest MedTech Updates | Stryker Genesis Ambu BioCardia Abbott atHeart","description":"FDA Clearance to Single-Use Gastroscope; Stryker\u2019s Tornier Shoulder Arthroplasty; Abbott\u2019s Dual-Chamber Leadless Pacemaker; Genesis Acquires","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","og_locale":"en_US","og_type":"article","og_title":"Latest MedTech Updates | Stryker Genesis Ambu BioCardia Abbott atHeart","og_description":"FDA Clearance to Single-Use Gastroscope; Stryker\u2019s Tornier Shoulder Arthroplasty; Abbott\u2019s Dual-Chamber Leadless Pacemaker; Genesis Acquires","og_url":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2022-02-10T12:46:24+00:00","article_modified_time":"2022-03-10T04:57:55+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart.png","type":"image\/png"}],"author":"DelveInsight","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"DelveInsight","Est. reading time":"11 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","url":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","name":"Latest MedTech Updates | Stryker Genesis Ambu BioCardia Abbott atHeart","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart.png","datePublished":"2022-02-10T12:46:24+00:00","dateModified":"2022-03-10T04:57:55+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd"},"description":"FDA Clearance to Single-Use Gastroscope; Stryker\u2019s Tornier Shoulder Arthroplasty; Abbott\u2019s Dual-Chamber Leadless Pacemaker; Genesis Acquires","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart.png","width":772,"height":482,"caption":"medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/0d96a31a370c143ffdb481d985d7edfd","name":"DelveInsight","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/f9314f22b8c5b61d496451e91f32488d2457ecb59283b7b2ad7e82d330b47aba?s=96&d=mm&r=g","caption":"DelveInsight"}}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/arawat"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2022\/02\/10181323\/medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Congenital Heart Defect Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Esophageal Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Gastroendoscopes<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">medical device<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">MedTech Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">MedTech News<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pacemakers Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Structural Heart Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Transcatheter Aortic Valve Replacement<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Congenital Heart Defect Devices<\/span>","<span class=\"advgb-post-tax-term\">Esophageal Cancer<\/span>","<span class=\"advgb-post-tax-term\">Gastroendoscopes<\/span>","<span class=\"advgb-post-tax-term\">medical device<\/span>","<span class=\"advgb-post-tax-term\">MedTech Market<\/span>","<span class=\"advgb-post-tax-term\">MedTech News<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Pacemakers Market<\/span>","<span class=\"advgb-post-tax-term\">Structural Heart Devices<\/span>","<span class=\"advgb-post-tax-term\">Transcatheter Aortic Valve Replacement<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 4 years ago","modified":"Updated 4 years ago"},"absolute_dates":{"created":"Posted on Feb 10, 2022","modified":"Updated on Mar 10, 2022"},"absolute_dates_time":{"created":"Posted on Feb 10, 2022 6:16 pm","modified":"Updated on Mar 10, 2022 10:27 am"},"featured_img_caption":"medtech-news-for-stryker-genesis-ambu-biocardia-abbott-atheart","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/15965","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=15965"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/15965\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/15979"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=15965"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=15965"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=15965"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=15965"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=15965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}