Argon Medical Devices has announced the enrollment of the first patient in the CLEAN-PE (Clot Lysis Evaluation of Aspiration using the Novel Pro-aspiration Extraction set for Pulmonary Embolism) study. This multicenter, prospective trial will assess the safety and efficacy of the Cleaner Pro Thrombectomy System in removing blood clots from the lungs of patients diagnosed with pulmonary embolism (PE).
The CLEAN-PE study, led by principal investigator Dr. Aravinda Nanjundappa from the Cleveland Clinic, aims to enroll over 100 patients across the United States. The first procedure was performed by Dr. David M. Zlotnick at Buffalo General Medical Center in Buffalo, New York.
Cleaner Pro Thrombectomy System
The Cleaner Pro Thrombectomy System is a catheter-based aspiration device designed for the removal of thrombi and emboli. It comprises a user-controlled handpiece, a large-bore aspiration catheter, a dilator, and a single-use aspiration pump and canister. The device recently launched under the trade name Cleaner Vac for removing fresh, soft thrombi and emboli from peripheral venous vasculature. However, it is not yet FDA-cleared for use in the pulmonary vasculature for treating PE.
Pulmonary Embolism: A Critical Need
Pulmonary embolism occurs when a blood clot migrates to the lungs, obstructing blood flow. This condition can be life-threatening, with mortality rates reaching up to 30% if left untreated. Approximately 900,000 individuals in the United States are affected by PE each year, highlighting the urgent need for effective and innovative treatment options. Recent data indicates that pulmonary embolism mortality rates have increased in the last decade.
Expert Perspectives
Dr. Zlotnick expressed enthusiasm about the study, stating, "We are proud to enroll the first patient in the CLEAN-PE study utilizing the Cleaner Pro Thrombectomy system. Unique treatment options are emerging for the management of this patient population. We are excited to evaluate a new device for patients diagnosed with pulmonary embolism."
George Leondis, President & CEO of Argon Medical, added, "Enrolling the first patient into the CLEAN-PE study is a monumental step forward for the solution we designed, and we are excited to discover the difference The Cleaner Vac Thrombectomy System can make for patients with this life-threatening condition."
