OpSens Commences SAFE-TAVI Study for European Approval of SavvyWire

October 26, 2022—OpSens Inc. announced the successful completion of the first cases in the SAFE-TAVI clinical study in Europe, which is evaluating the company’s SavvyWire left ventricular rapid pacing in transcatheter aortic valve replacement (TAVR) procedures in Europe. Ander Regueiro, MD, with 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,” commented Dr. Regueiro in the company’s press release. “We successfully used it on three cases today, 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.”

This study is part of the OpSens clinical strategy in advance of CE Mark approval that will lead to the commercialization of SavvyWire in Europe.

According to the company, SavvyWire is a sensor-guided TAVR solution that provides 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. 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.

In the United States, OpSens announced FDA clearance of SavvyWire on September 15, 2022. On April 26, the company announced Health Canada approval for the SavvyWire guidewire.

The SAFE-TAVI study is planned to be conducted at up to nine hospitals: eight centers across Spain and at the Quebec Heart and Lung Institute in Quebec City, Canada. The study 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.

Josep Rodés-Cabau, MD, from the Quebec Heart and Lung Institute, is the global Principal Investigator of the SAFE-TAVI study. Dr. Rodés-Cabau will oversee and coordinate the Principal Investigators in their respective Spanish hospitals.

“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 Dr. Rodés-Cabau in the press release. “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.”