OpSens SavvyWire Evaluated in European SAFE-TAVI Study

October 23, 2023—OpSens Inc. announced the publication of results from SAFE-TAVI, a clinical study on the safety and efficacy of left ventricular (LV) rapid pacing using the company’s SavvyWire in transcatheter aortic valve replacement (TAVR) procedures in Europe.

The study is evaluating the potential benefits of the device in eliminating the need for venous access, reducing procedure time, and avoiding potential complications associated with right ventricular pacing. In April, the company announced the completion of enrollment in SAFE-TAVI.

The company stated that the results were published by Ander Regueiro, MD, et al online in JACC: Cardiovascular Interventions. Dr. Regueiro, who is from Hospital Clinic Barcelona in Spain, will also present the data during an emerging clinical science and research session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

According to OpSens, SAFE-TAVI demonstrated that pacing with the SavvyWire led to a significant reduction of systolic aortic pressure below 60 mm Hg in 98.3% of patients, along with successful valve positioning in 99.2% of patients. SavvyWire in combination with the OptoMonitor 3 enabled invasive hemodynamic assessment without any additional catheter exchanges in 99.2% of patients.

In terms of safety, 99.2% of patients were free from major complications related to SavvyWire, with only one case of pacing loss due to movement of the wire during deployment.

“We successfully used the SavvyWire in a large variety of anatomies, implanting valves from all major companies, including Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Meril Life,” commented Dr. Regueiro in the OpSens press release. “LV rapid pacing is beneficial to restrict the range of motion of the heart muscle during TAVR for optimal valve placement. The rapid pacing feature is important in SavvyWire’s performance, in addition to providing real-time, accurate hemodynamic measurement during the TAVR procedure.”

The SAFE-TAVI study was designed by Principal Investigator Josep Rodes-Cabau, MD, from the Quebec Heart and Lung Institute in Quebec City, Canada. SAFE-TAVI is a prospective, multicenter study to evaluate LV rapid pacing using SavvyWire in TAVR procedures in a real-world patient population.

The study enrolled 119 patients with severe aortic valve stenosis requiring a TAVR procedure in which LV rapid pacing was considered appropriate. It was conducted in eight centers across Spain and used an independent data and safety monitoring board, noted the company.

OpSens has United States FDA clearance and Health Canada approval to commercialize the SavvyWire for TAVR. The guidewire is designed to be a three-in-one solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable LV pacing without the need for adjunct devices or venous access, stated OpSens.