FDA Clears Siemens' Smaller Ultrasound Catheter

Siemens has received 510(k) clearance from the FDA to market the new ACUSON AcuNav 8F ultrasound catheter.

The new catheter, sized at 8 French, is 33 percent smaller in the cross-sectional area than the existing AcuNav 10F catheter and enables improved access in all patients, particularly smaller patients for left heart applications in electrophysiology and interventional cardiology.

The smaller catheter provides visualization of vascular and cardiac anatomy and physiology, measurement of blood flow and visualization of other devices throughout the entire heart. The AcuNav 8F catheter is currently available on the Sequoia ultrasound platforms, the ACUSON CV70 cardiovascular system and the ACUSON Cypress cardiovascular system.