Results of the SAFE-TAVI Clinical Study, addressing aortic stenosis, will be presented at the Transcatheter Cardiovascular Therapeutics Conference (TCT), TCT 2023, to be held October 23-26 in San Francisco, CA, according to OpSens, a Quebec-based medical device company. Image courtesy: OpSens
October 19, 2023 — OpSens, a medical device cardiology-focused company, has announced that results of the “SAFE-TAVI Clinical Study: SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures” will be released on October 25 during the Transcatheter Cardiovascular Therapeutics Conference (TCT), TCT 2023, to be held in San Francisco, CA. The TCT is an annual scientific symposium of the Cardiovascular Research Foundation (CRF) and promoted by planners as the premier educational meeting specializing in interventional cardiovascular medicine, attracting more than 10,000 attendees from over 90 countries around the world.
The SAFE-TAVI study enrolled 119 patients and was conducted in nine renowned hospitals including eight centers across Spain and one in Canada. The SavvyWire is the first and only sensor-guided TAVI solution, designed to optimize TAVI workflow and support lifetime patient management, according to a written statement issued by the company ahead of the TCT conference. The Quebec-based company, which delivers solutions based on proprietary optical technology, issued a statement noting that the results will be presented by Ander Regueiro, MD.
The SavvyWire enables significant TAVI procedural benefits by supporting multiple steps over the same device without exchange, while delivering continuous, accurate hemodynamic measurements and display. "OpSens has designed the SavvyWire to help drive continued optimization of TAVI procedures without compromise, focusing on incorporating critical functions on the guidewire powered by our patented premier Fidela second generation fiber optic sensor technology," said Louis Laflamme, OpSens President and Chief Executive Officer.
The statement also reported that the global TAVI market is expected to exceed 400,000 procedures by 2025 and surpass 600,000 by 2030.
In addition to presenting the SAFE-TAVI clinical trial results, OpSens will also be sponsoring a scientific breakfast Satellite Program "Minimalistic TAVI with SavvyWire: Optimizing without Compromising" on the same day as the results, October 25, at the Presentation Theater 2. The company noted that the symposium will feature moderator Philippe Genereux, MD, (Morristown Medical Center) along with speakers including Ander Regueiro, MD (Hospital Clinic de Barcelona), James Harvey, MD (WellSpan York) and Samuel Horr, MD (Centennial Heart).
Background on Aortic Valve Stenosis and TAVI
Aortic valve stenosis occurs when the heart's aortic valve narrows, preventing it from opening completely and restricting blood flow from the heart to the main artery (aorta) and then to the rest of the body.
The TAVI procedure was initially only indicated for inoperable patients with severe symptomatic aortic stenosis, and later for patients at high surgical risk. Clinical studies such as PARTNER and COREVALVE have since shown better or equivalent clinical outcomes in intermediate and low surgical risk patients. The OpSens statement noted that TAVI procedure is rapidly evolving toward a minimalist approach that advances the procedure and supports lifetime patient management. It further offered that the TAVI procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients.
Focusing mainly on cardiology, the Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. The OptoWire is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of more than 250,000 patients in more than 30 countries. It is approved for sale in the U.S., the European Union, the United Kingdom, Japan and Canada.
OpSens announced that it had received FDA clearance during TCT 2022 in Boston, MA, and received Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR), as previously reported by DAIC. The company specified that the guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.