OpSens Inc. announced new data supporting the safety and efficacy of its SavvyWire recently approved by Health Canada for transcatheter aortic valve replacement (TAVR) procedures. The results of the 20 patient first-in-human clinical study of the SavvyWire were presented earlier at the 2022 EuroPCR conference, and simultaneously published in the EuroIntervention journal. The new clinical data presented by Dr. Josep Rodés-Cabau from the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec or "IUCPQ") support the safety and efficacy of the SavvyWire for TAVR procedures.

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 performed at IUCPQ by Dr. Rodés-Cabau and at the Montreal Heart Institute by Dr. Reda Ibrahim. 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. Importantly, 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. The SavvyWire is a third-generation, intelligent and pre-shaped structural guidewire, with integrated pressure monitoring and the capacity to perform left ventricular pacing.

This device aims at improving procedural efficiency and clinical outcomes by allowing multiple steps over the same device without exchange, in line with the minimalist approach. TAVR Procedure Evolution: Aortic valve stenosis occurs when the heart's aortic valve narrows, which prevents the valve from opening fully, restricting blood flow from the heart into the main artery (aorta) and onward to the rest of the body. Initially, the TAVR procedure was only indicated for inoperable patients and then for high-risk surgical patients.

Clinical programs like ''PARTNER III'' and ''Evolut Low Risk'', have since shown better or equivalent clinical outcomes in intermediate and low-risk patients. The TAVR procedure is now evolving quickly with a minimalist approach that allows the procedure to be faster and the patients to be discharged earlier, sometimes on the same day. The TAVR procedure is on the rise, driven by an aging of the population and recent studies that demonstrate its benefits to patients of all conditions.