Longer-length catheter receives FDA clearance
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the B. Braun Medical Inc. Introcan Safety 2 Deep Access IV Catheter, the newest addition to the Introcan Safety 2 IV Catheter portfolio. Combining the Introcan Safety 2 Deep Access IV Catheter with the trusted technologies of the original Introcan Safety 2 Multi-Access and Introcan Safety Deep Access Catheters offers an advanced solution combining the strengths of both devices. The catheter provides fully automatic passive safety needlestick protection and multi-access blood control in longer lengths and is designed to access deeper veins in patients with difficult vascular access and to achieve longer dwell times.
The Introcan Safety Deep Access IV Catheter has been shown to significantly increase peripheral intravenous catheter (PIVC) dwell times to approximately 5.7 days – compared to 3.8 days for standard long PIVCs – to help reduce PIVC restarts and help reduce escalation to more costly, 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, and there’s no need to occlude the vessel during insertion or any time the hub is accessed. https://www.bbraunusa.com
FDA approval for catheter, 510(k) for software
Boston Scientific Corp. received U.S. Food and Drug Administration (FDA) approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and FDA 510(k) clearance for the new FARAVIEW Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSE Pulsed Field Ablation (PFA) System. These technologies are compatible exclusively with Boston Scientific’s existing cardiac mapping technology and the company’s OPAL HDx Mapping System.
“The addition of the FARAWAVE NAV Ablation Catheter and FARAVIEW Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the FARAPULSE PFA System,” says Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. https://www.bostonscientific.com
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