{"id":12336,"date":"2021-06-03T17:58:15","date_gmt":"2021-06-03T12:28:15","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=12336"},"modified":"2021-07-24T12:58:25","modified_gmt":"2021-07-24T07:28:25","slug":"latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo","title":{"rendered":"Latest Medtech Commercial, Regulatory and Clinical Updates For &#8211; Abbott, BD, CooperVision, Procyrion, TricValve, and others"},"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-6a002c57dcf4c\" 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-6a002c57dcf4c\"  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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#Abbott_receives_CE_Mark_for_Navitor%E2%84%A2_the_Latest-Generation_Transcatheter_Aortic_Valve_Implantation_TAVI_System_for_Aortic_Stenosis_treatment\" >Abbott receives CE Mark for Navitor&#x2122;, the Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System for Aortic Stenosis treatment\u00a0<\/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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#SIRONA_the_worlds_first_and_largest_RCT_comparing_Sirolimus_VS_Paclitaxel_balloon_for_the_treatment_of_Peripheral_Arterial_Disease_progresses_rapidly\" >SIRONA, the world&#8217;s first and largest RCT comparing Sirolimus V\/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease, progresses rapidly<\/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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#GC_Aesthetics%C2%AE_introduces_the_next_generation_of_breast_implants_to_market\" >GC Aesthetics\u00ae introduces the next generation of breast implants to market\u00a0<\/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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#CooperVision_DreamLite%C2%AE_Ortho-K_Lenses_receives_European_Approval_for_slowing_progression_of_Myopia\" >CooperVision DreamLite\u00ae Ortho-K Lenses receives European Approval for slowing progression of Myopia\u00a0<\/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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#BD_introduces_Industry-First_Ready-to-Use_Iodine-Based_Surgical_Irrigation_System\" >BD introduces Industry-First Ready-to-Use Iodine-Based Surgical Irrigation System\u00a0<\/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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#Procyrion_declares_successful_First-in-Human_Cases_in_Cardiorenal_Syndrome_patients_with_Aortix%E2%84%A2_Percutaneous_Mechanical_Circulatory_Support_Device\" >Procyrion declares successful First-in-Human Cases in Cardiorenal Syndrome patients with Aortix&#x2122; Percutaneous Mechanical Circulatory Support Device\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#SoftWave_Tissue_Regeneration_Technologies_patented_Extracorporeal_Shock_Wave_Device_the_OrthGold_100%C2%AE\" >SoftWave Tissue Regeneration Technologies patented Extracorporeal Shock Wave Device, the OrthGold 100\u00ae\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#TricValve%C2%AE_Transcatheter_Bicaval_Valves_System_obtains_CE_Mark\" >TricValve\u00ae Transcatheter Bicaval Valves System obtains CE Mark\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#CUREXOs_spinal_surgery_robot_%E2%80%98CUVIS-spine_received_FDA_clearance\" >CUREXO&#8217;s spinal surgery robot, &#8216;CUVIS-spine&#8217; received FDA clearance\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#EndoFresh_received_FDA_510k_Clearance_for_its_ground-breaking_Disposable_Digestive_Endoscopy_System\" >EndoFresh received FDA 510(k) Clearance for its ground-breaking Disposable Digestive Endoscopy System<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#Boston_Scientific_receives_CE_Mark_for_EXALT%E2%84%A2_Model_B_Disposable_Bronchoscope\" >Boston Scientific receives CE Mark for EXALT&#x2122; Model B Disposable Bronchoscope\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#Micro_Interventional_Devices_Inc_received_Breakthrough_Device_Designation_from_FDA_for_the_MIA%E2%84%A2-T_Percutaneous_Tricuspid_Annuloplasty_System\" >Micro Interventional Devices, Inc. received Breakthrough Device Designation from FDA for the MIA&#x2122;-T Percutaneous Tricuspid Annuloplasty System\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#Varian_secures_FDA_%E2%80%9CBreakthrough_Device_Designation%E2%80%9D_for_its_Cardiac_Radioablation_CRA_System_for_the_treatment_of_Refractory_Ventricular_Tachycardia_VT\" >Varian secures FDA &#8220;Breakthrough Device Designation&#8221; for its Cardiac Radioablation (CRA) System for the treatment of Refractory Ventricular Tachycardia (VT)\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.delveinsight.com\/blog\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\/#FH_ORTHO_announces_the_first_case_using_e-ORTHO_Shoulder_Software\" >FH ORTHO announces the first case using e-ORTHO Shoulder Software\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-abbott-receives-ce-mark-for-navitor-the-latest-generation-transcatheter-aortic-valve-implantation-tavi-system-for-aortic-stenosis-treatment\"><span class=\"ez-toc-section\" id=\"Abbott_receives_CE_Mark_for_Navitor%E2%84%A2_the_Latest-Generation_Transcatheter_Aortic_Valve_Implantation_TAVI_System_for_Aortic_Stenosis_treatment\"><\/span><strong>Abbott receives CE Mark for Navitor&#x2122;, the Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System for Aortic Stenosis treatment\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 17, 2021, Abbott <\/strong>received <strong>CE Mark<\/strong> for its latest-generation <strong>transcatheter aortic valve implantation (TAVI) system, Navitor&#x2122;. <\/strong>This<strong> <\/strong>marks the minimally invasive device availability in Europe for patients with <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/aortic-stenosis-market\">severe aortic stenosis<\/a><\/strong> having high or extreme <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/surgical-site-infections-ssi-market\">surgical risk<\/a><\/strong>.\u00a0<\/p>\n\n\n\n<p>The company is advancing TAVI therapies with its Navitor valve that offers physicians and patients less invasive options to treat heart diseases using <strong>Abbott&#8217;s <\/strong>industry-leading <strong>FlexNav&#x2122; delivery system<\/strong>. The Navitor device is implanted with Abbott&#8217;s FlexNav delivery system, which obtained CE Mark in 2020. It offers a slim design with the lowest TAVI delivery system profile, allowing the treatment of people with vessels as tiny as 5.0 mm.<\/p>\n\n\n\n<p><strong>Michael Dale<\/strong>, <strong>senior vice president of Abbott&#8217;s structural heart business,<\/strong> said in a statement that<em> <\/em>the innovative design of the Navitor valve paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, allowing better <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/transcatheter-aortic-valve-replacement-market\">valve placement<\/a><\/strong> and performance for patients so they can get back to living fuller, healthier lives. This approval strengthens their structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-sirona-the-world-s-first-and-largest-rct-comparing-sirolimus-v-s-paclitaxel-balloon-for-the-treatment-of-peripheral-arterial-disease-progresses-rapidly\"><span class=\"ez-toc-section\" id=\"SIRONA_the_worlds_first_and_largest_RCT_comparing_Sirolimus_VS_Paclitaxel_balloon_for_the_treatment_of_Peripheral_Arterial_Disease_progresses_rapidly\"><\/span><strong>SIRONA, the world&#8217;s first and largest RCT comparing Sirolimus V\/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease, progresses rapidly<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 24 2021, Concept Medical Inc.<\/strong> focused on <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-vascular-interventions-market\">vascular intervention drug delivery devices<\/a><\/strong>, updated the status of <strong>SIRONA Randomized Control Trial (RCT),<\/strong> which compares head-to-head, <strong>Sirolimus versus Paclitaxel Drug-Eluting Balloon Angioplasty in femoropopliteal arterial diseases (SIRONA)<\/strong>.<\/p>\n\n\n\n<p>It is the world&#8217;s first RCT investigating the use of Sirolimus drug-coated balloon (DCB) (MagicTouch PTA \u2013 Concept Medical) V\/S Paclitaxel DCB for the femoropopliteal <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-artery-disease-and-stenosis-treatment-devices-market\">artery disease treatment<\/a><\/strong>.<\/p>\n\n\n\n<p>SIRONA is an Investigator-Initiated and driven, prospective, multi-centre, core lab adjudicated randomised trial to compare and assess the safety and efficacy of Sirolimus Coated balloon versus Paclitaxel Coated Balloon (CE certified devices) in the treatment of <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/spinal-stenosis-market\">stenosed <\/a><\/strong>or occluded lesions in the superficial femoral artery (SFA), and\/or popliteal artery (P1) in <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-arterial-disease-pad-pulmonary-vascular-disease-pvd-market\">Peripheral Arterial Disease patients<\/a><\/strong>. The study will enrol a total of 478 patients randomised 1:1 (MagicTouch PTA:Paclitaxel Coated Balloon) across 30 sites in Germany and Austria and will be led by the Principal Investigator <strong>Prof. Dr. Ulf Teichgr\u00e4ber of Jena University Hospital, Germany<\/strong>; the study is rushing with 20 patients already enrolled.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-gc-aesthetics-introduces-the-next-generation-of-breast-implants-to-market\"><span class=\"ez-toc-section\" id=\"GC_Aesthetics%C2%AE_introduces_the_next_generation_of_breast_implants_to_market\"><\/span><strong>GC Aesthetics\u00ae introduces the next generation of breast implants to market\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 25 2021, GC Aesthetics, Inc.<\/strong> has launched its next generation of breast implants, <strong>PERLE &#x2122;<\/strong>. It is a highly innovative line of smooth breast implants featuring <strong>BioQ &#x2122;<\/strong>, proprietary surface technology, GCA&#8217;s industry-leading gel technology (<strong>Emunomic &#x2122; Breast Tissue Dynamic Gel<\/strong>) and an improved version of the safety features that have underpinned GCA&#8217;s longstanding excellent safety record.&nbsp;<\/p>\n\n\n\n<p>PERLE &#x2122; will initially be launched in European markets and other markets worldwide to follow in the coming months.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-coopervision-dreamlite-ortho-k-lenses-receives-european-approval-for-slowing-progression-of-myopia\"><span class=\"ez-toc-section\" id=\"CooperVision_DreamLite%C2%AE_Ortho-K_Lenses_receives_European_Approval_for_slowing_progression_of_Myopia\"><\/span><strong>CooperVision DreamLite\u00ae Ortho-K Lenses receives European Approval for slowing progression of Myopia\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 25 2021, CooperVision Specialty EyeCare&#8217;s Procornea DreamLite\u00ae night lenses<\/strong> obtained European approval for decreasing the progression of <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/myopia-market\">myopia <\/a><\/strong>in children and young adults. DreamLite\u00ae night lenses can be utilised for myopia control with children who have refraction of -0.75 D to -5.00 D and cylindrical refraction with a maximum of -2.50 D.<\/p>\n\n\n\n<p>This is the latest CooperVision myopia control product to gain the CE Mark, joining EyeDream and Paragon CRT\u00ae ortho-k designs, MiSight\u00ae 1 day soft contact lenses, and SightGlass Vision Diffusion Optics Technology spectacle lenses. The company has the world&#8217;s most extensive portfolio of evidence-based myopia control interventions.<\/p>\n\n\n\n<p><strong>Dr. Juan Carlos Arag\u00f3n, President, CooperVision Specialty EyeCare,<\/strong> told in a statement that<em> <\/em>their commitments to innovations such as DreamLite\u00ae night lenses, providing broader access to optical interventions with scientifically demonstrated outcomes, and investing in widespread education for eye care professionals and parents are examples of why CooperVision continues to lead the <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/myopia-treatment-devices-market\">myopia<\/a><\/strong> management category. The latest CE Mark will help ECPs communicate with even more confidence about DreamLite\u00ae lenses&#8217; ability to slow the progression of myopia.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-bd-introduces-industry-first-ready-to-use-iodine-based-surgical-irrigation-system\"><span class=\"ez-toc-section\" id=\"BD_introduces_Industry-First_Ready-to-Use_Iodine-Based_Surgical_Irrigation_System\"><\/span><strong>BD introduces Industry-First Ready-to-Use Iodine-Based Surgical Irrigation System\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 25 2021, Becton, Dickinson and Company (BD)<\/strong> declared the availability of <strong>BD Surgiphor&#x2122;<a href=\"https:\/\/www.delveinsight.com\/report-store\/sternal-wound-infection-market\"> Sterile Wound Irrigation System<\/a><\/strong>, the first and only <strong>ready-to-use aqueous povidone-iodine (PVP-I) irrigation solution <\/strong>that mechanically frees and eliminates wound debris. It can help hospitals meet best practices set forth by U.S. health agencies, including the Joint Commission&#8217;s 2020 national patient safety goals. <strong>BD acquired BD Surgiphor&#x2122; from Orthophor, LLC in November 2020.\u00a0<\/strong><\/p>\n\n\n\n<p><strong>Kevin Kelly, worldwide president of Surgery for BD, <\/strong>informed that BD Surgiphor proffers hospitals with a ready-made solution for wound irrigation, launching a new tool in the sterile field that is labelled, effective, and simple to use during a procedure. The launch of BD Surgiphor will bring more simplicity to the sterile field and meet best practices established by the U.S. and global health agencies. The availability of BD Surgiphor&#x2122; moves BD Surgery&#8217;s portfolio beyond the current focus of surgical site skin prep and into intraoperative solutions. They also believe BD is well-positioned to continue growing its presence in the surgical setting.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-procyrion-declares-successful-first-in-human-cases-in-cardiorenal-syndrome-patients-with-aortix-percutaneous-mechanical-circulatory-support-device\"><span class=\"ez-toc-section\" id=\"Procyrion_declares_successful_First-in-Human_Cases_in_Cardiorenal_Syndrome_patients_with_Aortix%E2%84%A2_Percutaneous_Mechanical_Circulatory_Support_Device\"><\/span><strong>Procyrion declares successful First-in-Human Cases in Cardiorenal Syndrome patients with Aortix&#x2122; Percutaneous Mechanical Circulatory Support Device\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>May 25 2021<\/strong>, <strong>Procyrion, Inc. <\/strong>announced the successful treatment of the first patients in the company&#8217;s pilot trial to assess the performance of its novel <strong>Aortix&#x2122;<\/strong> percutaneous mechanical circulatory support (pMCS) device in <strong>cardiorenal syndrome (CRS) <\/strong>patients. The company is focused on improving outcomes for patients with <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/implantable-cardiac-monitors-market\">cardiac <\/a><\/strong>and renal impairment and has begun its pilot trial in Australia and expanded to the U.S. after obtaining Investigational Device Exemption (IDE) approval in April from the U.S. Food and Drug Administration (FDA).<\/p>\n\n\n\n<p><strong>Dr. Jennifer Cowger, <\/strong>Medical Director of the Mechanical Circulatory Support Program and Co-Director of the Cardiac Intensive Care Unit at<strong> Henry Ford Hospital in Detroit, MI,<\/strong> said that<em> <\/em>they are thrilled to be the first centre in the U.S. to treat CRS patients with the Aortix device. The procedure was performed safely and efficiently due to the pump&#8217;s position in the aorta versus the heart, which enabled the rapid deployment of the catheter-based pump and significantly reduced the risk of stroke and damage to the heart. After finishing therapy, the patient showed significant improvement in the key hemodynamic parameters, shed over 10 litres of excess fluid, and significantly improved creatinine levels, a measure of kidney function.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-softwave-tissue-regeneration-technologies-patented-extracorporeal-shock-wave-device-the-orthgold-100\"><span class=\"ez-toc-section\" id=\"SoftWave_Tissue_Regeneration_Technologies_patented_Extracorporeal_Shock_Wave_Device_the_OrthGold_100%C2%AE\"><\/span><strong>SoftWave Tissue Regeneration Technologies patented Extracorporeal Shock Wave Device, the OrthGold 100\u00ae\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 19 2021, SoftWave Tissue Regeneration Technologies<\/strong> <strong>patented<\/strong> extracorporeal shock wave device, the <strong>OrthGold 100\u00ae<\/strong>, which received FDA clearance on <strong>May 4, 2021<\/strong>, for the indications of a temporary rise in local blood circulation, relief of minor aches and <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-pain-market\">pains<\/a><\/strong>, and connective tissue activation.\u00a0<\/p>\n\n\n\n<p>According to <strong>John Warlick, CEO of SoftWave TRT<\/strong>, this revolutionises the way pain is treated in a therapeutic setting. With a company focus on innovation, adding more licenses, and contributing to their pipeline of future clearances and approvals, they believe SoftWave TRT is positioned to provide the best shock wave technology and be the leader in this increasing segment of medical technology.<\/p>\n\n\n\n<p>SoftWave TRT has approval from the FDA to treat superficial, partial-thickness, second-degree burns in adults, and the <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetic-foot-ulcers-dfus-market\">treatment of Diabetic Foot Ulcers (DFUs)<\/a><\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-tricvalve-transcatheter-bicaval-valves-system-obtains-ce-mark\"><span class=\"ez-toc-section\" id=\"TricValve%C2%AE_Transcatheter_Bicaval_Valves_System_obtains_CE_Mark\"><\/span><strong>TricValve\u00ae Transcatheter Bicaval Valves System obtains CE Mark\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 20 2021, OrbusNeich\u00ae Medical Company Ltd.<\/strong> and <strong>P&amp;F Products &amp; Features\u00ae<\/strong>, under the joint partnership <strong>OrbusNeich P&amp;F<\/strong>, received <strong>CE mark approval<\/strong> for the <strong>TricValve\u00ae <a href=\"https:\/\/www.delveinsight.com\/report-store\/transcatheter-aortic-valve-replacement-market\">Transcatheter <\/a>Bicaval Valves System<\/strong>.<\/p>\n\n\n\n<p>This is developed to treat caval reflux present in severe tricuspid regurgitation cases without removing the defective tricuspid valve and is available in different diameters for each model (SVC and IVC) designed to adapt to the anatomic features of the superior and inferior vena cava.&nbsp;<\/p>\n\n\n\n<p>Both the companies, <strong>OrbusNeich and P&amp;F<\/strong>, have agreed to the exclusive distribution and manufacturing of a range of innovative minimally invasive heart valve products in the Asia Pacific region in November 2020.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-curexo-s-spinal-surgery-robot-cuvis-spine-received-fda-clearance\"><span class=\"ez-toc-section\" id=\"CUREXOs_spinal_surgery_robot_%E2%80%98CUVIS-spine_received_FDA_clearance\"><\/span><strong>CUREXO&#8217;s spinal surgery robot, &#8216;CUVIS-spine&#8217; received FDA clearance\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 20, 2021, CUREXO Corp<\/strong>., the Medical robot specialist company, received FDA approval for their independently developed <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/spinal-trauma-devices-market-market\">spinal <\/a><\/strong>surgery robot &#8216;<strong>CUVIS-spine<\/strong>&#8216;.<\/p>\n\n\n\n<p>This is followed by <strong>Korea (2019)<\/strong> and <strong>Europe CE (2020)<\/strong> certificate and is the third license that the company have acquired. CUREXO plans to expand their focus on global markets, including the US and Europe.<\/p>\n\n\n\n<p><strong>Mr Jae-Joon Lee, CEO of CUREXO<\/strong>, said<em> <\/em>that the spinal surgery robot &#8216;CUVIS-spine&#8217; that they have developed and manufactured with their technology has acquired FDA (US)&#8217;s licensing. This is the 3rd license they have acquired, followed by Korea and Europe, and now they can sell the solution in all countries, including the US, which is the most significant medical market. Moreover, he also added that CUREXO plans to focus on the medical robots sales, including &#8216;<strong>CUVIS-joint&#8217;, &#8216;CUVIS-spine&#8217; and &#8216;Morning Walk<\/strong>&#8216; to the Korean market and advanced medical markets (the US and Europe).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-endofresh-received-fda-510-k-clearance-for-its-ground-breaking-disposable-digestive-endoscopy-system\"><span class=\"ez-toc-section\" id=\"EndoFresh_received_FDA_510k_Clearance_for_its_ground-breaking_Disposable_Digestive_Endoscopy_System\"><\/span><strong>EndoFresh received FDA 510(k) Clearance for its ground-breaking Disposable Digestive Endoscopy System<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 24, 2021, EndoFresh Disposable Digestive Endoscopy System<\/strong> has received <strong>FDA approval<\/strong> for its <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/endoscopy-fluid-management-systems-market\">endoscopy system<\/a><\/strong>, which features a camera system with innovative all-in-one design, disposable upper GI endoscope and disposable colonoscope, and are used together with the medical display and other peripheral devices to allow physicians to visualise, diagnose and operate <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/gastrointestinal-stromal-tumor-gist-market\">gastrointestinal <\/a><\/strong>endoscopy.\u00a0\u00a0<\/p>\n\n\n\n<p>According to <strong>Dr. Lee, EndoFresh CEO<\/strong>, medical practitioners, with this novel system, could offer patients a secure experience available at any time and anywhere. It helps to prohibit the risk of cross-infection and minimise the workload in preoperative screening and postoperative disinfection.<\/p>\n\n\n\n<p>The global flexible endoscope market is blossoming for safety and effectiveness; many manufacturers have engaged in the R&amp;D of the disposable endoscope. The company addresses the traditional challenge of expanding endoscopy procedures while ensuring its single-use devices are cost-effective, risk-controllable and accessible.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-boston-scientific-receives-ce-mark-for-exalt-model-b-disposable-bronchoscope\"><span class=\"ez-toc-section\" id=\"Boston_Scientific_receives_CE_Mark_for_EXALT%E2%84%A2_Model_B_Disposable_Bronchoscope\"><\/span><strong>Boston Scientific receives CE Mark for EXALT&#x2122; Model B Disposable Bronchoscope\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 25 2021, Boston Scientific Corporation<\/strong> has obtained a <strong>CE mark<\/strong> for the <strong>EXALT &#x2122; Model B Single-Use Bronchoscope<\/strong>, a single-use device designed for procedural performed at the bedside in the intensive care unit, in the operating room and in the <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/bronchoscope-market\">bronchoscopy<\/a><\/strong>. <strong>The company will begin the marketing of the device in Europe in the coming weeks.<\/strong><\/p>\n\n\n\n<p>The EXALT Model B Bronchoscope will be proffered in three sizes &#8211; <strong>Small, Normal and Large<\/strong> &#8211; for various bronchoscopy procedures such as secretion management, <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/airway-management-devices-market\">airway <\/a><\/strong>intubation, percutaneous tracheostomy, endotracheal tube placement double lumen and biopsies.<\/p>\n\n\n\n<p><strong>Professor Kaid Darwiche, Head of the Interventional Respiratory Department at the Ruhrlandklinik in Germany, <\/strong>said that since single-use bronchoscopes are relatively new, there is a need for constant innovation so that physicians can directly and precisely visualise the lungs and airways of patients. The EXALT Model B Bronchoscope offers a clear, crisp image and high-power suction, two essentials in successfully recognising any abnormalities in the patient&#8217;s airways.<\/p>\n\n\n\n<p><strong>Dave Pierce, executive vice president and president of MedSurg and president of Endoscopy, Boston Scientific<\/strong>, said that single-use endoscopes are becoming the preference of many physicians due to their ability to remove the risk of infection associated with endoscopes that can lead to inefficient reprocessing while increasing operational efficiency in the hospital environment. Innovation is at the heart of their mission, and the <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/bronchoscope-market\">EXALT Model B Bronchoscope<\/a><\/strong> is designed to provide physicians with high-quality functionality and the feel of a reusable endoscope while meeting increased patient safety needs and improving efficiency.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-micro-interventional-devices-inc-received-breakthrough-device-designation-from-fda-for-the-mia-t-percutaneous-tricuspid-annuloplasty-system\"><span class=\"ez-toc-section\" id=\"Micro_Interventional_Devices_Inc_received_Breakthrough_Device_Designation_from_FDA_for_the_MIA%E2%84%A2-T_Percutaneous_Tricuspid_Annuloplasty_System\"><\/span><strong>Micro Interventional Devices, Inc. received Breakthrough Device Designation from FDA for the MIA&#x2122;-T Percutaneous Tricuspid Annuloplasty System\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 27 2021, <\/strong>The <strong>U.S. Food and Drug Administration (FDA)<\/strong> granted <strong>Micro Interventional Devices (MID) <\/strong>a <strong>Breakthrough Device Designation<\/strong> for its <strong>MIA&#x2122;-T Percutaneous Tricuspid Annuloplasty System<\/strong>, used to treat <strong>moderate-severe tricuspid regurgitation (TR)<\/strong> via a 12F catheter-based system. This addresses the unmet needs in the treatment of structural <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/congenital-heart-disease-pipeline-insight\">heart disease<\/a><\/strong>.\u00a0<\/p>\n\n\n\n<p>The safety and performance of MIA-T have been shown in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites. The encouraging 12-month follow-up data was submitted for CE Mark approval in December 2020. The company anticipates receiving CE Mark approval and IDE approval to initiate the STTAR-US pivotal study by the end of 2021.<\/p>\n\n\n\n<p><strong>Michael Whitman, President and CEO of MID,<\/strong> said that the relative simplicity, safety and security of the MIA-T system would help many patients suffering from moderate-severe tricuspid regurgitation in the United States. They expect that breakthrough device designation will speed the process to commercialisation so patients, physicians and the healthcare system can profit from this technology.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-varian-secures-fda-breakthrough-device-designation-for-its-cardiac-radioablation-cra-system-for-the-treatment-of-refractory-ventricular-tachycardia-vt\"><span class=\"ez-toc-section\" id=\"Varian_secures_FDA_%E2%80%9CBreakthrough_Device_Designation%E2%80%9D_for_its_Cardiac_Radioablation_CRA_System_for_the_treatment_of_Refractory_Ventricular_Tachycardia_VT\"><\/span><strong>Varian secures FDA &#8220;Breakthrough Device Designation&#8221; for its Cardiac Radioablation (CRA) System for the treatment of Refractory Ventricular Tachycardia (VT)\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 26 2021, <\/strong>the <strong>U.S. Food and Drug Administration (FDA)<\/strong> granted <strong>Varian<\/strong>, a Siemens Healthineers company, a <strong>Breakthrough Device Designation<\/strong> for its <strong>cardiac radioablation (CRA) system<\/strong>, currently in development as a non-invasive therapy for select patients with <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ventricular-tachycardia-v-tach-or-vt-pipeline-insight\">refractory ventricular tachycardia (VT)<\/a>.<\/strong>\u00a0<\/p>\n\n\n\n<p>Varian&#8217;s CRA system was designated a Breakthrough Device by the FDA due to its potential to proffer a more effective treatment for select patients with <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ventricular-dysfunction-market\">refractory VT<\/a><\/strong>.<\/p>\n\n\n\n<p><strong>Kolleen Kennedy, President, Proton Solutions and Growth Office, Varian<\/strong>, told in a statement, the early positive clinical results hints that non-invasive cardiac radioablation could offer new hope for patients with refractory VT. They look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fh-ortho-announces-the-first-case-using-e-ortho-shoulder-software\"><span class=\"ez-toc-section\" id=\"FH_ORTHO_announces_the_first_case_using_e-ORTHO_Shoulder_Software\"><\/span><strong>FH ORTHO announces the first case using e-ORTHO Shoulder Software\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> May 27 2021, Olympus Corporation <\/strong>competed for a first use case of the 510(k) cleared <strong>e-ORTHO Shoulder software<\/strong> developed by <strong>FH ORTHO<\/strong>, a company that Olympus purchased in November 2020. The case, conducted by Brian Schofield, MD, was an Arrow Prime shoulder replacement in which the next generation e-ORTHO 3D planning software was utilised for preoperative <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/otological-drill-burrs-drill-surgical-power-tool-market\">surgical technique<\/a><\/strong> planning.<\/p>\n\n\n\n<p><strong>Dr. Schofield of Schofield, Hand and Bright Orthopedics, Sarasota, Fl <\/strong>said they believe that this case may have saved OR time because of their pre-operative planning with e-ORTHO. They look forward to continuing use of the e-ORTHO system, which helps with optimising glenoid adjustment, assists in adapting to the unique anatomical features of each patient, and could help a surgeon visualise a potential complication pre-operatively while allowing for contingency planning to address potential complications.<\/p>\n\n\n\n<p>In October 2020, the FH ORTHO received 510(k) clearance for its e-ORTHO planning software, saving OR time by allowing physicians to plan their surgical technique more efficiently. The web-based e-ORTHO platform uses CT scans of the entire scapula to construct a 3-D model of the anatomy to assist in preoperative surgical technique planning without the need for costly custom instruments often associated with software planning systems.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abbott receives CE Mark for Navitor&#x2122;, the Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System for Aortic Stenosis treatment\u00a0 On May 17, 2021, Abbott received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor&#x2122;. This marks the minimally invasive device availability in Europe for patients with severe aortic stenosis having high or extreme [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":12342,"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":[349,16779,420,639],"industry":[17226,17225],"therapeutic_areas":[17278],"class_list":["post-12336","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-latest-pharma-news","tag-medtech","tag-news","tag-pharma-news","industry-medical-devices","industry-pharmaceutical","therapeutic_areas-other-diseases"],"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 &amp; Updates | Abbott, CooperVision, Procyrion and others<\/title>\n<meta name=\"description\" content=\"CUREXO&#039;s &#039;CUVIS-spine&#039; received FDA clearance, Abbott&#039;s Navitor\u2122 and Varian&#039;s Cardiac Radioablation (CRA) System gets approval from..\" \/>\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\/latest-medtech-updates-for-abbott-bd-procyrion-tricvalve-curexo\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News &amp; Updates | Abbott, CooperVision, Procyrion and others\" \/>\n<meta property=\"og:description\" content=\"CUREXO&#039;s &#039;CUVIS-spine&#039; received FDA clearance, Abbott&#039;s 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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\">Latest pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">MedTech<\/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\">pharma news<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Latest pharma news<\/span>","<span class=\"advgb-post-tax-term\">MedTech<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 5 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Jun 3, 2021","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Jun 3, 2021 5:58 pm","modified":"Updated on Jul 24, 2021 12:58 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