Argon Commences CLEAN-PE Study of Cleaner Pro Thrombectomy System

January 9, 2025—Argon Medical Devices announced the first patient enrollment in the CLEAN-PE study, which is estimated to enroll > 100 patients at hospitals across the United States.

According to the company, the prospective, multicenter CLEAN-PE study aims to evaluate the safety and efficacy of the Cleaner Pro thrombectomy system for removing blood clot from the lungs in patients diagnosed with pulmonary embolism (PE).

The multicenter study is led by National Principal Investigator Aravinda Nanjundappa, MD, an interventional cardiologist with the Cleveland Clinic in Cleveland, Ohio. The first patient procedure was conducted by interventional cardiologist David M. Zlotnick, MD, at Buffalo General Medical Center in Buffalo, New York.

“We are proud to enroll the first patient in the CLEAN-PE study utilizing the Cleaner Pro thrombectomy system,” commented Dr. Zlotnick in the company’s press release. “Unique treatment options are emerging for the management of this patient population. We are excited to evaluate a new device for patients diagnosed with PE.”

The company stated that the catheter-based Cleaner Pro aspiration thrombectomy system comprises a user-controlled handpiece, a large-bore aspiration catheter, a dilator, and a single-use aspiration pump and canister.

The Cleaner Pro system was recently launched under the trade name Cleaner Vac for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature.

The Cleaner Vac thrombectomy system is not currently cleared by the FDA for use in the pulmonary vasculature for treating PE, advised the company.