OpSens Inc. has announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for the SavvyWire, its new guidewire for transcatheter aortic valve replacement (TAVR) procedures. Photo credit: OpSens Inc.
October 6, 2022 – OpSens Inc., a Quebec-based medical device cardiology-focused company, has announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for the SavvyWire, its new guidewire for transcatheter aortic valve replacement (TAVR) procedures. The announcement was made during the Cardiovascular Research Foundation's (CRF) Transcatheter CardiovascularTherapeutics (TCT) annual symposium, TCT 2022, held Sept. 16-20 in Boston, MA.
The SavvyWire is the first and only Sensor-Guided TAVR solution, according to a company statement, which is 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.
“For OpSens, FDA clearance is a key milestone and an achievement, introducing an entirely new category of innovation to the structural heart device market segment. The SavvyWire has been designed to provide best in class valve delivery capability and improve workflow in the TAVR procedure,” commented Louis Laflamme, President and Chief Executive Officer of OpSens. He added, “SavvyWire uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.” Laflamme noted that the company introduced physicians to the SavvyWire at Cardiovascular Research Foundation (CRF) TCT 2022, which would be followed by initiating a limited market release of the product to a select number of physician thought-leaders in the weeks following.
The TAVR Evolution
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.
For more information: https://opsensmedical.com/products/savvywire/
Find more TCT22 coverage here: https://www.dicardiology.com/channel/tc