Clinical

Clinical Overview

Venous thromboembolism (VTE) is the third leading vascular disease after heart attack and stroke.1 Globally, there are about 10 million cases of VTE every year.1 Pulmonary embolism (PE) is responsible for most VTE deaths.2

WHAT IS VTE?

Venous thromboembolism is when a blood clot blocks the flow of blood through a vein. VTE includes pulmonary embolism and deep vein thrombosis, when a clot forms in the deep veins, usually in the legs.

WHAT IS PE?

Pulmonary embolism occurs when part of the blood clot breaks free and travels through the veins to the arteries of the lungs. It can be life-threatening and require immediate treatment.

EVIDENCE

The ENGULF Clinical Trial is a prospective multicenter, FDA-approved IDE study evaluating the safety, feasibility and efficacy of the Hēlo™ PE Thrombectomy System for the treatment of pulmonary embolism. Committed to clinical science, the study is approached in two phases: feasibility and pivotal.

Feasibility (Complete)

National PI, Jay Giri, MD, MPH

Safety and feasibility demonstrated in 25 intermediate-risk PE patients.

Pivotal (ongoing)

National co-PIs, Andrew Klein, MD & Julie Bulman, MD

Evaluating safety and efficacy in patients with acute PE for FDA 510(k) clearance.

“Endovascular Engineering has the distinction of being the first early-stage company to develop a next generation purpose-built PE thrombectomy catheter that has been used in humans in a wide range of U.S. centers and is supported by published peer-reviewed clinical evidence.

Jay Giri, MD, MPH

Director of the Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania

Learn about the
ENGULF Clinical Trial