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The Intara Introducer Sheath is intended to maintain access to a patient's peripheral or central vasculature (excluding coronary and neuro vasculature) to facilitate the introduction of therapeutic or diagnostic devices. The 10-French sheath is resistant to kinking and it offers enhanced visibility to assist with the introduction, navigation, and delivery of devices for a variety of vascular procedures. Argon Medical anticipates the Intara Introducer Sheath will help facilitate use of the company's TLAB Transvenous Liver Biopsy System and the Scorpion® and Traveler™ Portal Vein Access Sets, as well as stents for the transjugular intrahepatic portosystemic shunt (TIPS) procedure.
"The Intara Introducer Sheath is an upgrade to the current market options. It provides more resilience, ease of use, and safety throughout the TIPS procedure and stent placement," said Dr. Dylan Suttle, Interventional Radiologist, Greensboro Radiology in Greensboro, NC.
The TLAB Transvenous Liver Biopsy System is an expansion of Argon Medical's TLAB Transjugular Liver Biopsy System, adding FDA-clearance for a unique approach for collecting biopsy samples from the liver via access in the femoral vein. The system includes a novel tool that allows users to safely adjust the shape of the device to best suit a patient's unique anatomy. The new addition is reinforced by a recent 500-patient retrospective review demonstrating the safety and efficacy of transfemoral transcaval liver biopsies versus the traditional transjugular approach. The authors of this review, including Dr. Jacob Cynamon, Interventional Radiologist at Montefiore Medical Center in Bronx, New York, found transfemoral transcaval liver biopsies had reduced complication rates with no hepatic injuries1. Argon Medical designed the TLAB Transvenous Liver Biopsy System in conjunction with patents licensed from Montefiore on which Dr. Cynamon is a primary inventor.
"The TLAB Transvenous Liver Biopsy System approved for both transjugular and transfemoral use, offers an alternative femoral approach for physicians to achieve technical and histopathologic success while minimizing procedural time and complications. With the transfemoral approach, we have seen the benefits first-hand and I believe this will be a positive step forward for patients and physicians performing liver biopsies," said Dr. Cynamon.
"We are pleased to expand our liver management portfolio with the addition of the Intara Introducer Sheath and the TLAB Transvenous Liver Biopsy System," said George Leondis, President & CEO, Argon Medical. "Our company is dedicated to applying innovation to improve the devices interventionalists use to diagnose and treat liver diseases. This is demonstrated by our cadence of new product introductions in this space, including the BioPince Ultra Full-core Biopsy Instrument, the Scorpion Portal Vein Access Sets, and the Traveler Portal Vein Access Sets."
"Liver diseases (cirrhosis, hepatitis, and cancer) account for 1 out of every 25 deaths worldwide, illustrating the need for faster, easier, and more accurate diagnosis and treatment options2. We listened to the advice of physician experts in this field to guide development of the Intara Introducer Sheath and the TLAB Transvenous Liver Biopsy System. As we commercialize these new devices, we are excited to see their expertise translate into positive outcomes for interventionalists and the patients they serve," said Tom Younker, Senior Vice President of Global Marketing, Argon Medical.
The Intara Introducer Sheath and TLAB Transvenous Liver Biopsy System were first introduced at Portal 360 - The Portal Intervention Symposium in Chicago, IL on September 27, 2024. Both devices are now available in the U.S. and Canada.
About Argon Medical
Since its founding in 1972, Argon Medical Devices has earned a reputation for delivering innovative products, superior service, and exceptional value for Interventional Radiologists, Vascular Surgeons, and Interventional Cardiologists worldwide. Argon is proud to have over 1,200 employees, and manufacture products in the United States in Texas, Illinois, New York, and Wisconsin. Argon brands are well-known globally, highlighted by the Option™ ELITE IVC Filter, the CLEANER™ Rotational Thrombectomy System, the BioPince™ Ultra Full-Core Biopsy Instrument, and SKATER™ Percutaneous Drainage Catheters. By utilizing a well-established sales and marketing infrastructure, Argon serves its global customers through a direct sales organization, and long-standing relationships with medical device distributors and strategic partners.
1 Peng R, Wattamwar K, Kuc N, Jagust M, Golowa Y, Cynamon J. Transjugular versus Transfemoral Transcaval Liver Biopsy: A Single-Center Experience in 500 Cases. J Vasc Interv Radiol. 2020 Sep;31(9):1394-1400. doi: 10.1016/j.jvir.2020.05.024. Epub 2020 Aug 11. PMID: 32798119.
2 Devarbhavi, Harshad et al. Global burden of liver disease: 2023 update. Journal of Hepatology, Volume 79, Issue 2, 516 - 537.
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The Intara™ Introducer Sheath and Dilator Set is indicated for introduction of therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.