Results of the 20-patient, first-in-human clinical study supporting the safety and efficacy of the SavvyWire (OpSens) guidewire for transcatheter aortic valve implantation (TAVI) were presented EuroPCR 2022 (17–20 May, Paris, France) and simultaneously published in EuroIntervention.
The new clinical data presented by Josep Rodés-Cabau (Quebec Heart and Lung Institute, Quebec, Canada) support the safety and efficacy of the SavvyWire for TAVI procedures, OpSens said in a press release. A total of 12 patients received an Evolut PRO+ (Medtronic) valve and eight patients received a Sapien 3/Ultra valve (Edwards Lifesciences). Patient enrolment was performed at Quebec Heart and Lung Institute by Rodés-Cabau and at the Montreal Heart Institute (Montreal, Canada) by Reda Ibrahim.
Investigators reported 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 TAVI 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, OpSens’ press release adds.
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.
OpSens recently announced that it has received Health Canada approval for the SavvyWire.
