OpSens SavvyWire for TAVR Procedures Evaluated in First-in-Human Study

May 19, 2022—OpSens Inc. announced new data supporting the safety and efficacy of SavvyWire, the company’s third-generation, intelligent, preshaped structural guidewire, which was recently approved by Health Canada for use in transcatheter aortic valve replacement (TAVR) procedures. The device provides integrated pressure monitoring and the capacity to perform left ventricular pacing.

According to the company, the new clinical data results from the 20-patient first-in-human clinical study support the safety and efficacy of SavvyWire for TAVR procedures. The data were presented by Josep Rodés-Cabau, MD, from the Quebec Heart and Lung Institute in Quebec City, Canada.

Dr. Rodés-Cabau et al published the findings online in EuroIntervention simultaneous with the presentation at the EuroPCR 2022 conference held May 17-20 in Paris, France.

OpSens stated that a total of 12 patients received an Evolut Pro+ (Medtronic) valve, and eight patients received a Sapien 3/Ultra valve (Edwards Lifesciences). Patient enrollment was conducted by Dr. Rodés-Cabau at Quebec Heart and Lung Institute and Réda Ibrahim, MD, at the Montréal Heart Institute in Montréal, Canada.

The investigators found that appropriate left ventricular rapid pacing was achieved in all patients, resulting in an adequate reduction of aortic pressure. No procedural mortality, stroke, cardiac perforation, or guidewire malfunction were reported.

Continuous and accurate recording of pressure measurements during the TAVR procedures was achieved in all patients, with an excellent correlation between systolic and left ventricular end-diastolic pressure obtained using traditional pigtail catheters and the new SavvyWire, reported OpSens.