Safety and effectiveness of the Vertex Pulmonary Embolectomy System in acute intermediate-risk pulmonary embolism: the SPIRARE II pivotal trial.

The 48-hour composite major adverse event (MAE) rate was 2.4% in 123 patients, meeting the prespecified safety performance goal.

• 3 of 123 patients experienced a composite MAE within 48 hours.
• The one-sided p-value against the performance goal was <0.0001.
• This was a co-primary endpoint in a prospective, single-arm, multicentre pivotal trial at 19 sites in the United States and Europe.

The RV/LV diameter ratio, assessed by core laboratory, fell significantly from baseline to 48 hours, exceeding the prespecified effectiveness performance goal.

• Mean RV/LV ratio decreased from 1.44±0.33 at baseline to 1.05±0.21 at 48 hours.
• The mean reduction was 0.39±0.33 (p<0.0001 versus the performance goal).
• RV/LV was measured by computed tomography angiography and was the second co-primary endpoint.

The study enrolled patients with acute intermediate-risk PE who were haemodynamically stable but had RV strain on imaging.

• Eligibility: symptom onset ≤14 days, CT angiography RV/LV ratio >0.9, and systolic blood pressure ≥90 mmHg.
• Total enrolled population was 123 patients.
• The study was a prospective, single-arm, multicentre pivotal investigation (ClinicalTrials.gov NCT06576427).

Prespecified secondary haemodynamic endpoints were collected immediately before and after the procedure in all patients.

• Secondary endpoints included mean pulmonary artery pressure, total pulmonary vascular resistance, and cardiac index.
• The abstract does not report the numerical values of these measures.
• The authors state that the system enabled consistent right ventricular unloading.

The authors conclude that Transforming Fixation (TFX) technology provides stable control and reliable vessel access in mechanical aspiration thrombectomy.

• TFX separates the flexibility needed for safe navigation from the support needed for procedural control.
• It is designed to address catheter stiffness and instability, which may limit access and prevent effective RV unloading in existing systems.
• The authors report that it delivered 'precise, stable control with reliable vessel access, enabling consistent right ventricular unloading.'