Penumbra's Indigo Aspiration System Meets Primary Endpoints in EXTRACT-PE Trial

November 6, 2019—Penumbra, Inc. announced that the EXTRACT-PE trial met its primary endpoints, demonstrating the safety and efficacy of the company’s Indigo aspiration system for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE). The data were presented in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.

EXTRACT-PE was a prospective, single-arm, multicenter trial that evaluated the safety and efficacy of the Indigo aspiration system in the treatment of acute PE. Investigators enrolled 119 patients at 22 study centers in the United States. The trial was conducted under an investigational device exemption from the FDA.

The company reported that he primary efficacy endpoint was met with a significant mean reduction in right ventricular/left ventricular ratio of 0.43, corresponding to a 27.3% reduction, at 48 hours after intervention.

The primary safety endpoint was reached with a low major adverse event composite rate of 1.7% within 48 hours. The major adverse event composite included device-related death, major bleeding, and device-related serious adverse events as measured by the clinical events committee.

Additional data included median time of Indigo system use (37 minutes) and median stay in the intensive care unit stay (1 day). No thrombolytic drugs were used in 98.3% of patients.

In the company’s announcement, the trial’s National Principal Investigator, Akhilesh Sista, MD, commented, “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.” Dr. Sista is Chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine in New York, New York.

Dr. Sista, who serves as Vice Chair of the recently published Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association (AHA), continued, “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.”

Pulmonary critical care specialist Victor F. Tapson, MD, an EXTRACT-PE steering committee member, stated, “From a pulmonologist’s perspective, the results of the EXTRACT-PE trial are another important dataset that help broaden the mechanical treatment options for patients with pulmonary embolism. The safety profile of the Indigo system and the low rate of bleeding events, combined with the significant reduction in RV/LV ratio seen in the EXTRACT-PE trial, can positively impact the emerging field of acute pulmonary embolism intervention.” Dr. Tapson is from Cedars-Sinai Medical Center in Los Angeles, California.