BrosMed receives FDA 510(k) clearance of the Tri-Wedge PTA Scoring Balloon Catheter

October 24th, 2024—BrosMed Medical Co., Ltd. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Tri-Wedge PTA Scoring Balloon Dilatation Catheter. “This represents yet another significant achievement in our effort to introduce BrosMed’s broad portfolio into the US market”, comments Scott J. Addonizio, Chief Operating Officer.

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is a triple-wire balloon system that is intended to dilatate stenosis in the peripheral vasculature and obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Three longitudinal metallic wires are placed 120 degrees apart, facilitating 360° focused force under reduced pressure with minimal slippage during inflation. Tri-Wedge results in a higher rate of procedural success, less patient discomfort, and improved patency of the vessel(s).

Tri-Wedge features an ultra-low profile providing superior crossability, effortless tracking through tight lesions, AVF anastomosis, as well as long diffuse lesions of the lower extremity. This device could prove optimal in preparing and treating a lesion in conjunction with a peripheral DCB. Available in both 0.018’’ and 0.035’’ wire platforms and sizes ranging from 3.0mm to 8.0mm in diameter and 20mm to 60mm in length, with an overall catheter shaft length of 50cm, 75cm, 90cm, and 150cm.

About BrosMed

Specializing in the research, development, manufacturing, and global sales of interventional technologies and products for complex vascular diseases, BrosMed is the industry-leading multinational group in the field of intravascular interventional medical devices. We have over 40 product series and more than 520 product registration certificates worldwide. Our products cover cardiovascular intervention, peripheral intervention, vascular access, neurovascular intervention, and interventional accessories. Our products are marketed in over 100 countries and regions globally.

BrosMed Medical adheres to the mission of "Technology Embraces Life," actively practices a globalized integration of medical and engineering, and promotes an open innovation model of integrating industry, universities, and scientific research institutions. We are dedicated to continuously providing safe, effective, high-quality, and innovative intravascular interventional solutions for global experts and patients.