Argon Medical announces the first patient enrolment in the CLEAN-PE study. The prospective, multicentre 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). CLEAN-PE is estimated to enrol over 100 patients at various hospital facilities across the USA.
The multicentre study is led by principal investigator Aravinda Nanjundappa (Cleveland Clinic, Cleveland, USA). The first patient procedure took place at Buffalo General Medical Center in Buffalo, in New York, USA by David M Zlotnick.
“We are proud to enrol the first patient in the CLEAN-PE study utilising 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.” said Zlotnick.
“Data indicates that pulmonary embolism mortality rates have increased in the last decade. We aim to help physicians improve patient outcomes by developing new solutions that enable quicker and easier PE interventions. 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.” said George Leondis, president and chief executive officer at Argon Medical.
The Cleaner Pro thrombectomy system is a catheter-based aspiration thrombectomy device comprised of a user-controlled handpiece, a large-bore aspiration catheter, a dilator, and a single-use aspiration pump and canister.
