Edwards Lifesciences, Medtronic, and Inari Medical presented clinical trial data on their respective devices at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
Edwards' Transcatheter Tricuspid Valve Replacement
A study evaluating Edwards Lifesciences' transcatheter tricuspid valve replacement device, Evoque, met its primary endpoint. The trial enrolled 400 patients with severe symptomatic tricuspid regurgitation, with two-thirds undergoing valve replacement plus medical therapy and the remaining receiving medical therapy alone. The primary endpoint was a composite of outcomes including death from any cause and hospitalization for heart failure.
Published in The New England Journal of Medicine, the study revealed that after one year, the valve replacement cohort showed better performance on the composite primary endpoint. This improvement was largely driven by changes in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), a measure of health status, which improved in approximately 23% of valve patients compared to 6% in the medical therapy group. Notably, the trial, as further detailed in the Journal of the American College of Cardiology, showed no significant mortality benefit at 12 months.
Analysts suggest that the absence of a mortality benefit at 12 months may be a slight disappointment to some investors, though many anticipated a longer timeframe for such an outcome. Expectations remain that a mortality benefit may be observed at 18 or 24 months.
Medtronic's Renal Denervation for Hypertension
Medtronic presented two-year data from its Symplicity Spyral renal denervation device trial. The data indicated that patients treated with the device experienced sustained reductions in 24-hour ambulatory systolic blood pressure and office-based systolic blood pressure compared to those undergoing a sham procedure. The Symplicity Spyral system received FDA approval in November 2023, and Medtronic is focused on expanding payer coverage for this hypertension treatment.
Analysts from RBC Capital Markets highlighted Medtronic's optimism regarding the potential of the Symplicity Spyral Renal Denervation System for treating hypertension, noting ongoing positive discussions with the Centers for Medicare and Medicaid Services and continued pursuit of private payer coverage.
Inari's Thrombectomy Device for Pulmonary Embolism
Inari Medical shared results from a trial comparing its Flowtriever mechanical thrombectomy device to catheter-directed thrombolysis (CDT) in 550 intermediate-risk patients with acute pulmonary embolism. The PEERLESS trial, published in Circulation, met its composite primary endpoint, driven by reductions in ICU admission and length of stay.
Following the release of these results, Inari's stock price saw a significant increase. The trial data indicated that patients treated with Flowtriever experienced fewer instances of clinical deterioration and required less bailout therapy compared to those receiving CDT.
Analysts noted that the more severe complications and clinical deterioration observed in the CDT group could accelerate the adoption of mechanical thrombectomy, particularly with Flowtriever. However, some concerns were raised regarding the overall low mortality rates in both cohorts, questioning whether the patients were "sick enough" to fully demonstrate the device's benefits.
