Dive Brief:

• Medtronic’s Evolut FX has been linked to improved commissure alignment in transcatheter aortic valve replacement (TAVR) procedures, according to a retrospective analysis.
• Correct alignment of TAVR implants with the native valve is associated with improved coronary blood flow and valve hemodynamic performance, leading Medtronic to identify the factor as a way to differentiate its latest system from its older devices and Edwards Lifesciences’ rival products.
• The multicenter, retrospective analysis of data on 168 patients showed commissural alignment of 95.8%, a figure that Medtronic said is a significant improvement on its older Evolut systems.

Dive Insight:

As TAVR has moved into younger, healthier patients, physicians have sought ways to make the procedure more predictable and consistent and thereby ensure it remains an attractive option in lower-risk people. In a presentation at PCR London Valves 2022, Gilbert Tang, surgical director of the structural heart program at Mount Sinai Health System, set out how Evolut FX may support those objectives.

“In this early experience the Evolut FX system provided several enhancements over the PRO+ system not only because of its easier trackability, but more importantly achieving a more symmetric deployment on release and improved commissural alignment with reduced coronary overlap. These features resulting in better procedural predictability and consistency in TAVR may be critical in low risk patients and broaden the adoption of TAVR to a wider population,” Tang said in a statement.

Tang’s statement is based on an analysis of data from six U.S. centers. As well as the 95.8% commissural alignment rate, the study found the 30-day rates of death and stroke were 1.2% and 1.8%, respectively. No patients suffered moderate or severe paravalvular leak 30 days after the procedure, although 13.2% people had mild cases of a complication that was a major concern in the early days of TAVR.

Medtronic’s press release lacked data from the cohort of 378 Evolut PRO+ patients from a single center that researchers compared to the Evolut FX analysis. The company said the new system “significantly improved commissure alignment during TAVR procedures compared to earlier generation Evolut systems,” adding that hemodynamic performance was similar to the older devices.

Commenting on his company’s most recent quarterly earnings last week, CEO Geoff Martha said Medtronic’s TAVR business grew “15% globally, including 17% in the United States,” in the period, though he didn’t specify if that growth was from the previous quarter or the same period a year earlier. Martha added that procedure volumes had yet to recover to pre-pandemic levels.