Us Fda Grants 510(K) Clearance To Avingers Tigereye St Image-Guided Cto Crossing System

Us Fda Grants 510(K) Clearance To Avingers Tigereye St Image-Guided Cto Crossing System

By, Admin 2 May 2023

Avinger, Inc., A Commercial-Stage Medical Device Company, Announced The Company Has Received 510(K) Clearance From The Us Food & Drug Administration (Fda) For Tigereye St, Its Next-Generation Image-Guided Chronic Total Occlusion (Cto) Crossing System.Tigereye St Expands And Advances Avinger'S Proprietary Image-Guided Cto Product Line With Compelling New Features And Benefits. Tigereye St Incorporates Design Upgrades To The Tip Configuration And Catheter Shaft To Increase Crossing Power And Procedural Success In Challenging Lesions, As Well As Design Enhancements For Ease Of Image Interpretation During The Procedure. Tigereye St Continues To Provide The High-Definition Real-Time Intravascular Imaging, User-Controlled Deflectable Tip, And Faster Rotational Speeds Introduced To The Platform In 2021. Product Specifications Include A Working Length Of 140 Cm, 5 French Sheath Compatibility, And Low Crossing Profile For Treatment Of Lesions In The Peripheral Vessels Both Above And Below The Knee.Avinger Will Initiate A Limited Launch Of Tigereye St In The Current Quarter With Plans To Expand To Full Commercial Availability In The Us In The Third Quarter Of 2023."The Fda Clearance Of Tigereye St Extends Our Ability To Empower Physicians With The Unique Benefits Of Real-Time Visualization From Within The Artery During Treatment To Enhance Procedural Safety, Efficacy, And Efficiency," Commented Jeff Soinski, Avinger'S President And Ceo. "We Are Excited To Initiate The Limited Launch Of This New Device And Most Of All To Provide An Important New Tool For Interventional Physicians To Treat Their Most Challenging Cases."Dr. Jaafer Golzar, Avinger'S Chief Medical Officer And A Highly Experienced Interventional Cardiologist Treating Patients With Peripheral Ctos Noted, "Treating Ctos Presents Significant Technical Challenges To Physicians, And We Have A Limited Set Of Minimally Invasive Tools To Provide Safe And Effective Outcomes For This High-Risk Patient Population. With Tigereye St, A Physician Can Precisely Control The Device To Stay Safely Within The Lumen While Successfully Crossing Challenging Lesions. Intraluminal Crossing Provides A Wider Variety Of Treatment Options, Results In Less Potential For Vascular Injury, And Provides Better Long-Term Clinical Outcomes For Patients."Avinger'S Lumivascular Technology Incorporates An Onboard Image-Guidance System To Allow Physicians, For The First Time Ever, To See Inside The Artery During An Atherectomy Or Cto-Crossing Procedure By Using An Imaging Modality Called Optical Coherence Tomography, Or Oct. During The Procedure, High-Resolution Intravascular Oct Images Are Displayed On Avinger'S Lightbox Console In Real-Time To Guide Therapy. Physicians Performing Therapeutic Procedures With Other Devices Must Rely Solely On X-Ray Images And Tactile Feedback To Guide Their Interventions While Treating Complicated Arterial Disease. With The Lumivascular Approach, Physicians Can More Accurately Navigate Their Devices And Treat Pad Lesions To Deliver Safe And Effective Outcomes, Without Exposing Healthcare Workers And Patients To The Negative Effects Of Ionizing Radiation.Avinger Is A Commercial-Stage Medical Device Company That Designs And Develops The First And Only Image-Guided, Catheter-Based System For The Diagnosis And Treatment Of Patients With Peripheral Artery Disease (Pad).

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