OpSens Inc. announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for the SavvyWire™ (SavvyWire), its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. The SavvyWire is the first and only Sensor-Guided TAVR solution, designed to support TAVR efficiency and lifetime patient management. The SavvyWire enables significant TAVR procedural benefits by supporting multiple steps over the same device without exchange, while delivering continuous, accurate hemodynamic measurements and display.

The Evolution of TAVR; Aortic valve stenosis occurs when the heart's aortic valve narrows, preventing it from opening completely and restricting blood flow from the heart to the main artery (aorta) and then to the rest of the body. The TAVR procedure was initially only indicated for inoperable patients with severe symptomatic aortic stenosis, and later for patients at high surgical risk. Clinical programs such as PARTNER and COREVALVE have since shown better or equivalent clinical outcomes in intermediate and low surgical risk patients.

The TAVR procedure is rapidly evolving toward a minimalist approach that advances the procedure and allows patients to leave the hospital earlier, sometimes the same day. The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.