Siemens AG has announced that it received 510(k) clearance from the US Food & Drug Administration to market its new Acuson AcuNav 8F catheter, designed for ultrasound examinations from inside the heart.
The company describes the product:
The ACUSON AcuNav™ Diagnostic Ultrasound Catheter brings the full force of ultrasound technology inside the heart. Physicians can now perform a complete ultrasound exam when it counts most – during interventional procedures and before the patient leaves the catheterization or electrophysiology lab. AcuNav is relied upon by electrophysiologists to provide critical visualization necessary to perform atrial fibrillation and other complex arrhythmia ablations. As interventional cardiologists replace open-heart surgical closure of septal defects with transcatheter techniques, the AcuNav catheter is their visualization tool of choice, even supplanting transesophageal imaging.
AcuNav is a sterile, single-use, 10 French ultrasound catheter designed for placement inside the venous system providing ultrasound images with unparalleled detail resolution and penetration, down to 15 cm in the heart. The user determines the desired tradeoff between resolution and penetration by choosing from up to four imaging frequencies, all at the touch of a button.
The catheter is compatible with the ACUSON Sequoia™, Aspen™ and Cypress™ echocardiography systems.
The technology is becoming very cool! Not just cool, but better and better for patients as well.
More at Siemens…