Cath Lab

The catheterization lab channel includes content related to interventional technologies for coronary and peripheral artery disease (PAD). Other cath lab transcatheter device technologies covered on this page included percutaneous treatment for stroke, venous interventions, heart valves, hypertension, heart failure and percutenous coronary interventions (PCI).

Primary endpoints across three studies underscore the importance of accuracy, utility, and efficiency in coronary artery disease diagnostics and clinical decision making
News | Cardiovascular Clinical Studies
HeartFlow to Announce New Data at SCCT23

July 28, 2023 — Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy ...

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Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR)
News | Stents
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent

July 27, 2023 — Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions ...

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Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to be introduced into patients who have procedures with this device.
News | Left Atrial Appendage (LAA) Occluders
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

July 26, 2023 — Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to ...

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Under the agreement, BIS will initiate the US commercialization activities for ŌNŌCOR’s ŌNŌ Retrieval Device.
News | Cardiovascular Business
ĹŚNĹŚCOR signs an exclusive US distribution agreement with B. Braun Interventional Systems

July 26, 2023 —ŌNŌCOR LLC, a medical technology company dedicated to developing essential safety tools and other ...

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SmartfIRE study is evaluating THERMOCOOL SMARTTOUCH SF Dual Energy Catheter’s potential to enable safe and simple procedures with the ability to deliver both radiofrequency (RF) and pulsed field ablation (PFA)
News | Atrial Fibrillation
Biosense Webster Completes Enrollment in Pivotal Trial Evaluating PFA and RF Dual Energy Catheter for Patients with Atrial Fibrillation in Europe

July 21, 2023 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson ...

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No statistical difference observed across sub-analyses for diabetes, lesion length, calcium, bailout stenting and occlusions in head-to-head study comparing Passeo-18 Lux DCB to In.Pact Admiral DCB
News | Drug-Eluting Balloons
BIOPACT RCT Subgroup Analyses Show Consistently Great Results for Passeo-18 Lux Drug-Coated Balloon

July 14, 2023 — BIOTRONIK announced the one-year subgroup results from the investigator-initiated BIOPACT randomized ...

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Illustration for the deployment and shaping process of the occluder.
News | Structural Heart Occluders
Transcatheter Closure of Perimembranous Ventricular Septal Defect Using a Novel Fully Bioabsorbable Occluder: Multicenter Randomized Controlled Trial

July 14, 2023 — In recent years, transcatheter intervention techniques have emerged as a promising alternative for the ...

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New service will provide rapid and comprehensive care to hundreds of heart patients every year for life-threatening emergencies and scheduled cardiac procedures.
News | Cath Lab
Mount Sinai Queens Opens New Cardiac Catheterization Lab to Expedite Care for Heart Attack Patients

July 13, 2023 — Mount Sinai Queens announced the opening of a new cardiac catheterization lab that will provide rapid ...

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Largest randomized trial of DynamX Bioadaptor to date with 2,400 patients enrolled, covering real-world population
News | Stents Drug Eluting
Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial

July 13, 2023 — Elixir Medical, a developer of breakthrough cardiovascular technologies, announced enrollment completion ...

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A subgroup analysis of the HOST-IDEA randomized controlled trial showed efficacy differences of Ultrathin Strut DES
News | Stents Drug Eluting
Late-Breaking Study Data: BIOTRONIK’s Orsiro DES Outperforms Other Ultrathin Strut Drug-Eluting Stent

July 12, 2023 — In a late breaking trial session during EuroPCR 2023 in Paris, on behalf of the HOST-IDEA study ...

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The U.S. Food and Drug Administration (FDA) has issued a Letter to Health Care Providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD)
News | Peripheral Artery Disease (PAD)
Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality

July 11, 2023 — The U.S. Food and Drug Administration (FDA) is informing healthcare providers about updated information ...

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Innovative platform designed for more personalized, tailored management of heart failure patients
News | Heart Failure
Adona Medical’s Next-Generation Heart Failure Management Platform Showcased at CSI Frankfurt 2023 Conference

July 10, 2023 — Adona Medical, a Shifamed portfolio company that aims to deliver advanced interatrial shunting and hemod ...

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Global clinical study aims to broaden evidence base by assessing clinical and economic benefits for the FFRangio System
News | FFR Technologies
CathWorks Announces First Patient Enrolled in Global ALL-RISE Study

June 28, 2023 — CathWorks announced that the first patient has been enrolled in the Advancing Cath Lab Results with FFRa ...

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Day-long summit organized by CRF and Fogarty Innovation will convene clinicians, entrepreneurs, industry, and government stakeholders for education, collaboration, and real-world insight
News | Stents Carotid
InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial

June 26, 2023 — InspireMD, Inc., developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of str ...

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Teleflex and Arrow International recall ARROW endurance extended dwell peripheral catheter system due to risk of catheter separation and leakage
News | Catheter
Teleflex and Arrow International Recall ARROW Endurance Extended Dwell Peripheral Catheter System

June 26, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Teleflex and Arrow ...

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