EXTRACT-PE: Indigo Aspiration Thrombectomy for Acute PE Meets Endpoints

Hollywood, FL (January 24, 2020) – Aspiration thrombectomy for acute pulmonary embolism (PE) with the Indigo Aspiration System (Penumbra) met primary efficacy and safety endpoints in its first prospective clinical trial.

More specifically, use of the device was associated with a 27.3% reduction in mean change in right-to-left ventricular diameter (RV/LV) ratio at 48 hours (1.47 to 1.04 at 48 hours; P<.0001), and with a 1.7% rate of major adverse events within 48 hours.

There were 3 major adverse events recorded in 2 of 119 patients: One groin bleed and one device-related death: hemoptysis followed by death 11 hours post-procedure due to sustained ventricular tachycardia.

“Interestingly, we found a 37-minute Indigo procedure time and an on-table pulmonary-artery pressure reduction, which speak to the promise of this technique. [As well,] intraprocedural thrombolytic drugs were not used in 98.3% of patients,” said Akhilesh Sista, MD, from the New York University, who presented the data at a late breaking trials session at the International Symposium on Endovascular Therapy (ISET).

Systolic pulmonary artery pressure dropped from 49 mmHg pre-procedure to 44.5 mmHg post-procedure (reduction, 4.7 mmHg; P<.0001).

EXTRACT-PE was a prospective, single-arm, multicenter trial conducted under an Investigational Device Exemption (IDE) from the FDA that evaluated the safety and efficacy of the Indigo system.

The trial enrolled 119 patients with symptomatic acute PE £14 days duration diagnosed by computed tomography angiography (CTA). Eligible patients had systolic blood pressure of at least 90 mmHg with evidence of RV/LV ratio >0.9.

“So, not massive PEs,” reported Dr. Sista. “And we didn’t want any confounders, so tPA administration within 14 days of baseline CTA was an exclusion.”

Indigo has an 8 French lumen and tip directionality for circumferential aspiration. There are also multiple material transitions which allow for smooth tracking and a separator technology at the tip, “which serves to both engage the clot and clear the lumen when a clot enters the mouth of the catheter,” Dr. Sista told attendees.