OpSens SavvyWire for TAVR Used in First Procedures in the United States After FDA Clearance

September 23, 2022—OpSens Inc. announced the first commercial uses of the SavvyWire for transcatheter aortic valve replacement (TAVR) procedures in the United States were performed by Philippe Généreux, MD, Director of the Structural Heart Program at Morristown Medical Center in Morristown, New Jersey, and his team.

According to OpSens, the sensor-guided SavvyWire 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.

“I am extremely pleased with the performance of the SavvyWire,” commented Dr. Généreux in the company’s press release. “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.”

On September 15, the company announced that it had received FDA 510(k) clearance for the SavvyWire guidewire for TAVR procedures. In April, the device was approved in Canada.

Louis Laflamme, President and CEO of OpSens, stated in the press release, “We are honored that Dr. Généreux and the Morristown Medical Center team performed the first series of SavvyWire procedures in United States. Dr. Généreux’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.”

Mr. Laflamme further advised, “OpSens will conduct a controlled release to a limited number of hospitals in the United States through the end of 2022, then initiate full launch in early 2023.”