- OpSens (OPS) has completed the first cases in its Safe-Tavi clinical study
- The study is examining SavvyWire left ventricular rapid pacing in transcatheter aortic valve replacement (TAVR) procedures in Europe
- The success of the first three implants aided by SavvyWire bode well for the product’s European commercialization
- OpSens offers fibre optic sensing technology for the medical, energy and industrial sectors
- OpSens (OPS) is up by 3.9 per cent, trading at $2.40 per share
OpSens (OPS) has completed the first cases in its Safe-Tavi clinical study.
SavvyWire is the world’s first and only sensor-guided TAVR solution.
The study is examining SavvyWire’s left ventricular rapid pacing in TAVR procedures in Europe.
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.
The study is part of OpSens’ pre-CE mark clinical strategy to offer SavvyWire in Europe. It includes 120 patients in up to nine hospitals in Spain and Canada with, among other conditions, severe aortic valve stenosis requiring a TAVR procedure in which left ventricular rapid pacing is necessary.
Dr. Josep Rodés-Cabau, from the Quebec Heart and Lung Institute, is serving as the study’s global principal investigator.
The news follows the first SavvyWire procedure in the U.S.
“I am extremely pleased with the performance of the SavvyWire,” said Dr. Regueiro, Hospital Clínic de Barcelona, one of the primary investigators of the study. “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,” he added.
OpSens offers fibre optic sensing technology for the medical, energy and industrial sectors.
OpSens (OPS) is up by 3.9 per cent, trading at $2.40 per share as of 11:47 am EST.