B. Braun's Introcan Safety 2 Deep Access IV Catheter Receives FDA Clearance
核心洞察
B. Braun Medical's Introcan Safety 2 Deep Access IV Catheter (搜索) has received FDA 510(k) clearance, expanding the Introcan Safety 2 portfolio.
The catheter combines features of the original Introcan Safety 2 Multi-Access and Deep Access catheters for enhanced vascular access.
Designed for deeper veins and longer dwell times, it aims to reduce PIVC restarts and the need for more invasive procedures.
B. Braun Medical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Introcan Safety® 2 Deep Access IV Catheter. This new device is an addition to the Introcan Safety 2 IV Catheter portfolio, designed to improve vascular access and patient outcomes.
The Introcan Safety 2 Deep Access IV Catheter (搜索) integrates the technologies of the original Introcan Safety 2 Multi-Access and Introcan Safety Deep Access Catheters. It offers clinicians a solution that combines the strengths of both devices, providing fully automatic passive safety needlestick protection and multi-access blood control in longer lengths. The catheter is designed to access deeper veins in patients with difficult vascular access and to achieve extended dwell times.
Enhanced Dwell Times and Reduced Complications
Clinical data has demonstrated that the Introcan Safety Deep Access IV Catheter can significantly increase PIVC dwell times to approximately 5.7 days, compared to 3.8 days for standard long PIVCs. This increase in dwell time is intended to reduce the frequency of PIVC restarts and the need for escalation to more costly and invasive devices, such as peripherally inserted central catheters (PICC).
The multi-access blood control hub in the Introcan Safety 2 Deep Access PIVC is designed to minimize blood exposure and reduce the need for cleanup of blood throughout IV therapy. The design eliminates the need to occlude the vessel during insertion or any time the hub is accessed, streamlining the IV therapy process.
Expert Commentary
Chad Laity, Director of Marketing, Vascular Access, IV Systems and Securement at B. Braun, stated, "We are excited to broaden our Introcan Safety 2 IV Catheter portfolio, allowing our customers to benefit from passive safety and blood exposure protection with deep access technology. By offering a reliable solution for challenging cases, we aim to help improve patient outcomes and reduce the need for more complex procedures."
Peripheral Advantage Program
The launch of the Introcan Safety® 2 Deep Access IV Catheter is aligned with B. Braun’s Peripheral Advantage Program. This program is designed to optimize clinical skills, enhance product performance, improve clinical outcomes, and elevate the overall patient experience with peripheral IV care in hospitals.