OpSens OptoWire and a Novel TAVR Interface Evaluated

May 18, 2022—OpSens Inc. announced newly published data supporting the correlation between OpSens’ OptoWire, powered by its Fidela sensor, and a novel transcatheter aortic valve replacement (TAVR) interface, with measurement derived from standard hemodynamic assessment, both before and after TAVR. The OpSens OptoWire is approved for sale in the United States, European Union, Japan, and Canada.

The results of the 20-patient clinical study were published by Philippe Généreux, MD, et al online in JSCAI: Journal of the Society for Cardiovascular Angiography & Intervention.

An accompanying editorial online in JSCAI, “Real-time Hemodynamic Monitoring During TAVR, Stepping Toward the Ideal TAVR Wire” by Tamara M. Atkinson, MD, and Charanjit Rihal, MD, addresses the study’s findings. Additionally, JSCAI provides an online panel discussion with the study investigators and editorial authors ahead of the 2022 SCAI scientific session held May 19-22 in Atlanta, Georgia.

According to OpSens, discrepancies between echocardiogram- and catheter-derived gradients have previously been reported by multiple groups after TAVR implantation, most likely caused by inherent limitations of echocardiographic data acquisition, and other phenomena such as flow recovery after TAVR implantation.

Key points in the new clinical data published by Généreux et al, include:

• Hemodynamic assessment derived from the OpSens OptoWire III and the new TAVR algorithm demonstrated excellent correlation with measurements derived from standard catheterization technique using two pigtails.
• Compared with transthoracic echocardiogram and transesophageal echocardiographic, the OpSens OptoWire III demonstrated the strongest correlation with catheterization measurement.

“These data support the accuracy of the Fidela optical sensor when compared to the gold standard of invasive hemodynamics using two pigtail catheters,” commented Dr. Généreux in the company’s press release. “I am excited to use a more efficient technique that avoids the cumbersome setup and multiple catheter exchanges, required for catheterization measurement, once the SavvyWire becomes available.”

OpSens noted that SavvyWire is a third-generation, intelligent, and preshaped 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. The SavvyWire was recently approved by Health Canada and has been submitted to the FDA for clearance.

The Fidela optical sensor embedded within the OptoWire III and the TAVR software algorithm integrated to the OpSens console are the same as the ones used for the SavvyWire. The OptoWire III is not currently indicated for assessing or diagnosing aortic stenosis, advised the company.