First U.S. Use of OpSens’ TAVR SavvyWire

Dr. Philippe Genereux, director of the Structural Heart Program at Morristown Medical Center in New Jersey, and his team, was the first in the United States to use OpSens Inc.’s SavvyWire in a transcatheter aortic valve replacement (TAVR) procedure. 

“I am extremely pleased with the performance of the SavvyWire,” said Genereux. “We successfully treated 10 consecutive patients with a variety of anatomies and levels of complexity including bicuspid valve, severe vessel tortuosity, horizontal aorta, failed prior surgical valve (valve-in-valve) using both balloon-expandable and self-expandable valves, and balloon valvuloplasty. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while enhancing accuracy and patient safety. I am excited to collaborate with OpSens to bring this disruptive technology to patients.”

SavvyWire is touted by OpSens as the world’s “first and only” sensor-guided TAVR solution. It provides a three-in-one 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. 

OpSens has received U.S. Food and Drug Administration clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). OpSens’ SavvyWire is on trend with a minimalist approach to TAVR and advances the procedure, allowing 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 more than 200,000 procedures and is expected to reach 400,000 in 2027.

“We are honored that Dr. Genereux, and the Morristown Medical Center team perform the first series of SavvyWire procedures in United States. Dr. Genereux’s prior work has been instrumental to the advancement and expansion of the TAVR field, and we are thrilled to be partnering with him and his team to streamline procedures and improve patient outcomes,” OpSens President and CEO Louis Laflamme said. “OpSens will conduct a controlled release to a limited number of hospitals in the U.S. through the end of 2022, then initiate full launch in early 2023.”

OpSens focuses mainly on cardiology. The company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used to diagnose and treat more than 150,000 patients in over 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada. OpSens is also involved in industrial activities in developing, manufacturing, and installing fiber optic sensing solutions for critical applications.