US-based Argon Medical Devices has expanded its liver management portfolio with the launch of two new products, the Intara Introducer Sheath and the TLAB Transvenous Liver Biopsy System.
The Intara Introducer Sheath is intended to provide access to a patient’s peripheral or central blood vessels, except coronary and neuro vessels, for introducing therapeutic or diagnostic devices.
The 10-French sheath is said to resist kinking and enhance visibility to help with the introduction, navigation, and delivery of devices for different vascular procedures.
According to Argon Medical, the sheath will support the use of its TLAB Transvenous Liver Biopsy System, Scorpion and Traveler Portal Vein Access Sets, and stents for TIPS procedures.
TIPS (transjugular intrahepatic portosystemic shunt) procedures involve inserting a stent to connect the portal veins to adjacent blood vessels that have lower pressure.
Argon Medical president and CEO George Leondis said: “We are pleased to expand our liver management portfolio with the addition of the Intara Introducer Sheath and the TLAB Transvenous Liver Biopsy System.”
Argon Medical global marketing senior vice president Tom Younker said: “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 options.
“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 commercialise these new devices, we are excited to see their expertise translate into positive outcomes for interventionalists and the patients they serve.”
Argon Medical designed the TLAB Transvenous Liver Biopsy System using patents licensed from the Montefiore Medical Center in Bronx, New York.
It extends the company’s TLAB Transjugular Liver Biopsy System and is approved by the US Food and Drug Administration (FDA) approval for a unique transfemoral approach.
The approach involves collecting biopsy samples from the liver via access in the femoral vein.
The device comes with a novel tool that allows users to safely adjust the shape of the device to conform to a patient’s unique anatomy.
The new addition is strengthened by a recent 500-patient retrospective review validating the safety and efficacy of transfemoral transcaval liver biopsies compared to a traditional approach.
According to the review, transfemoral transcaval liver biopsies resulted in reduced complication rates with no hepatic injuries.
Montefiore Medical Center interventional radiologist Jacob Cynamon said: “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 minimising 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.”
