OpSens Completes First SavvyWire Clinical Cases in Europe

OpSens Inc. has successfully completed the first cases in its SavvyWire clinical study in Europe. This trial is part of the OpSens pre-CE mark clinical strategy that will lead to commercializing SavvyWire in Europe.

The trial is examining the safety and efficacy of SavvyWire left ventricular rapid pacing in transcatheter aortic valve replacement procedures, or TAVR. Dr. Regueiro from Hospital Clínic de Barcelona, Spain, conducted the procedures as one of the primary investigators of the study. “I am extremely pleased with the performance of the SavvyWire,” said Regueiro. “We successfully used it on three cases, implanting three different systems, including a Navitor TAVI System from Abbott, an Evolut system from Medtronic, and a SAPIEN 3 valve from Edwards Lifesciences. There is no doubt the SavvyWire allowed us to optimize our efficiency and workflow, while enhancing accuracy and patient safety.”

OpSens’ SavvyWire has previously received Health Canada and U.S. Food and Drug Administration clearance. Using SavvyWire for left ventricular pacing can eliminate the need for venous access, reduce procedure time, and avoid potential complications associated with right ventricular pacing. 

Dr. Josep Rodés-Cabau, from the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec or “IUCPQ”), is the global principal investigator of the SAFE-TAVI study that will enroll 120 patients with, among other conditions, severe aortic valve stenosis requiring a TAVR procedure in which left ventricular rapid pacing is considered necessary. “The objective of the SAFE-TAVI study is to confirm the safety and efficacy of using left ventricular rapid pacing with the OpSens SavvyWire during TAVR procedures. Left ventricular rapid pacing is necessary to restrict the range of motion of the heart muscle during TAVR,” commented Rodés-Cabau. “This feature adds to the SavvyWire’s performance in enabling an efficient and effective workflow while providing real-time, accurate hemodynamic measurement in the TAVR procedure.”

The SAFE-TAVI study is planned to be conducted at up to nine hospitals: in eight centers across Spain and in Canada, at the IUCPQ. As the global principal investigator of the SAFE-TAVI study, Rodés-Cabau will oversee and coordinate the principal investigators in their respective Spanish hospitals.

“We are honored that Dr. Rodés-Cabau, who has led multiple clinical trials that have helped shape the field of interventional cardiology, including the recent SavvyWire first in-human study.  His clinical work has been and continues to be instrumental in the progression of the TAVR procedure, the treatment of aortic valve stenosis and many advances in cardiology,” OpSens President/CEO Louis Laflamme said.

SavvyWire is 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 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 in the diagnosis and treatment of more than 200,000 patients in over 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.
 
TAVR procedures are 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.