US healthcare company Penumbra has announced the positive results from the EXTRACT-PE trial of Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE).

Penumbra said that its EXTRACT-PE trial has reached the primary endpoints and demonstrated the safety and efficacy of the Indigo Aspiration System.

EXTRACT-PE trial national principal investigator Akhilesh Sista said: “The positive results of the EXTRACT-PE trial, the first prospective safety and efficacy study of the Indigo Aspiration System, are a step forward in building needed clinical evidence around catheter-based embolectomy in patients with acute pulmonary embolism.

“New AHA guidelines state that catheter-based embolectomy may have an important role in severe PE, but that more study is needed. EXTRACT-PE is an important first step in determining how and when we should employ promising and innovative catheter-based technologies such as the Indigo aspiration device.”

Penumbra Indigo Aspiration System removes blood clots

PE is a condition that occurs when blood clots traveling from the veins in the legs, get caught in the arteries of the lungs, blocking them from absorbing oxygen, and causes strain on the heart and other organs.

EXTRACT-PE is a prospective, single-arm, multicentre clinical study designed to evaluate the safety and efficacy of the Indigo Aspiration System in the treatment of acute PE.

Penumbra Indigo System is a continuous aspiration mechanical thrombectomy system intended to remove blood clots from the arteries and veins in the peripheral vasculature.

The system makes use of the Penumbra ENGINE aspiration source to deliver almost pure, continuous vacuum suction to the Indigo System Aspiration Catheters, to tackle thrombus in vessels of various sizes.

The study has been carried out under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA), enrolling 119 participants across 22 US study centres.

Device-related death, major bleeding, and device-related serious adverse events as measured by the clinical events committee include the major adverse event composite for the study.

The company said that it has presented the data at the Vascular InterVentional Advances (VIVA) Annual Meeting in Las Vegas, US.

Penumbra chairman and chief executive officer Adam Elsesser said: “The Indigo Aspiration System has demonstrated tremendous potential to address patients with clot in other parts of the body, and today’s data show its specific potential in the pulmonary arteries.

“Pulmonary embolism is a deadly disease where we see an unmet clinical need and patient opportunity, and we commend the dedication of physicians who are focused on addressing this area. We are excited about the excellent results of this trial and look forward to working together with physicians in the field to bring better treatment options to patients.”