The US Food and Drug Administration (FDA) has approved Transmural Systems’ Telltale, a dedicated electrosurgical guide wire to reduce the risk of coronary obstruction in high-risk patients undergoing transcatheter aortic valve replacement (TAVR).
US-based Transmural developed the Telltale guide wire, which is available for TAVR procedures treating both native aortic stenosis and bioprosthetic valve failure, as a dedicated system for ‘leaflet’ modification. The leaflet is a flap of tissue that, in rare TAVR cases, can shift position, blocking blood flow to the coronary arteries that supply blood to the heart. Research indicates that the complication has a mortality rate of 35%.
To address this issue, the National Institutes of Health (NIH) developed the BASILICA approach, a technique that uses electrosurgical energy to split the leaflet before valve deployment to reduce the risk of occlusion.
However, undertaken by modifying off-the-shelf guidewires, BASILICA is viewed as a technically demanding approach towards mitigating the risk of occlusion during TAVR. As a dedicated system, Transmural’s guide wire is therefore intended to streamline the BASILICA technique and make it more reproducible.
Transmural Systems’ CEO Kathleen Pizzuti commented: “The FDA’s clearance of Telltale reinforces our commitment to delivering a platform of intuitive, high-impact technologies that empower clinicians and improve patient outcomes.”
TAVR is indicated for patients with severe symptomatic aortic stenosis, a condition characterised by narrowing of the aortic valve tissue, often due to calcification that builds with age.
The global TAVR market is on a rapid growth course. Currently growing at a CAGR of 8%, the market is forecast to reach a valuation of around $12.5bn by 2034, up from $6.3bn in 2024, according to GlobalData analysis.
Edwards Lifesciences is leading the way, solidifying TAVR’s adoption rate worldwide. The company currently holds more than 60% of the global TAVR market share and 75% in the US, according to GlobalData estimates.
TAVR holds an advantage over surgical aortic valve replacement (SAVR) given its minimally invasive nature, leading to shorter recovery times and proves less intensive for patients. The approach has resulted in patient survival and improvement that is as good as or better than that of SAVR, according to GlobalData analysis.
During the European Society of Cardiology’s (ESC) Congress 2025, which took place in Madrid, Spain, from 29 August to 1 September, the ESC announced an update to its care guidelines for valvular heart disease.
The updated guidance outlined that TAVR be considered, even for asymptomatic patients, reflecting a shift from the previous ‘watchful waiting’ advisement. The update was largely informed by data from Edwards’ EARLY TAVR trial (NCT03042104).
