Vivasure Medical Secures CE Mark for First Fully Absorbable Large-Bore Vascular Closure System
• Vivasure Medical has received European CE mark approval for PerQseal Elite, the first fully absorbable, sutureless closure system designed specifically for large-bore cardiovascular procedures.
• The innovative device aims to improve procedural efficiency and patient outcomes in structural heart interventions like TAVR and EVAR, with planned launch in select European markets this summer.
• Unlike current closure methods, PerQseal Elite requires no pre-procedure steps and leaves no foreign materials behind, potentially reducing complications associated with traditional closure techniques.
Axcynsis Therapeutics' AT03-65 Receives FDA IND Clearance for CLDN6-Targeting ADC
• Axcynsis Therapeutics received FDA clearance for its IND application for AT03-65, a differentiated CLDN6-targeting antibody-drug conjugate (ADC).
• AT03-65 leverages Axcynsis' AxcynDOT™ technology for precise drug delivery to tumors expressing CLDN6, a target in various cancers.
• This regulatory milestone enables Axcynsis to advance AT03-65 into clinical trials, marking a significant step in developing novel cancer therapies.
• The ADC is designed to improve efficacy and reduce systemic toxicity compared to traditional chemotherapy, addressing unmet needs in oncology.
Pathogen-Reduced Cryoprecipitate Trial Aims to Improve Transfusion Outcomes in Cardiac Surgery
• A prospective, cluster-randomized trial is underway to compare pathogen-reduced cryoprecipitate (IFC) with conventional cryoprecipitated AHF in cardiac surgery patients.
• The primary goal is to assess whether IFC reduces the total number of non-cryo AHF/IFC blood components transfused during the first 30 days post-surgery.
• Secondary outcomes include the number of cryo AHF/IFC units wasted, time to transfusion, length of stay, and adverse events, providing a comprehensive effectiveness analysis.
• The study uses a pragmatic design, randomizing by month to reflect real-world clinical practice and minimize disruption to blood bank operations.
Inspira Technologies Expands European Footprint with Innovimed Agreement for INSPIRA ART Clinical Trials
• Inspira Technologies extends its service agreement with Innovimed Sp. z o.o to support clinical trials of INSPIRA ART medical devices across Europe.
• The collaboration aims to navigate the EU's regulatory landscape, leveraging Innovimed's expertise for market entry in countries like Poland, Czech Republic, and Slovakia.
• Inspira's devices target acute respiratory care, seeking to reduce mortality rates and risks associated with traditional mechanical ventilation for 20 million patients annually.
• The global ARDS market is projected to grow from $980.4 million in 2021 to $2.1 billion by 2030, driven by improved healthcare and increased research.
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