Argon Medical Devices has enrolled the first patient in a US-based study exploring a novel catheter-based device for managing blood clots in the lungs.
RT’s Three Key Takeaways:
- Study Aims to Improve PE Treatment: The CLEAN-PE study is evaluating the safety and efficacy of the Cleaner Pro thrombectomy system for treating pulmonary embolism, enrolling over 100 patients across the U.S.
- Device Offers Novel Approach: The Cleaner Pro thrombectomy system uses a catheter-based aspiration method designed to remove blood clots quickly and efficiently, potentially improving patient outcomes.
- High Stakes for Life-Threatening Condition: Pulmonary embolism affects approximately 900,000 people annually in the US, with a mortality rate of up to 30% if untreated.
Argon Medical Devices announced the first patient enrollment in the CLEAN-PE study, which aims to evaluate the safety and efficacy of the Cleaner Pro thrombectomy system for removing blood clots from the lungs in patients diagnosed with pulmonary embolism (PE).
CLEAN-PE is estimated to enroll over 100 patients at various hospital facilities across the United States.
The multicenter study is led by national principal investigator Aravinda Nanjundappa, MD, an interventional cardiologist at the Cleveland Clinic in Cleveland, Ohio. The first patient procedure took place at Buffalo General Medical Center in Buffalo, New York, by David M. Zlotnick, MD, an interventional cardiologist at Buffalo General Medical Center.
PE occurs when a blood clot migrates to the lungs and restricts blood flow. This condition is life-threatening with a mortality rate up to 30%, if left untreated. Approximately 900,000 people in the United States alone are affected by the condition each year.
“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,” says Zlotnick in a release.
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.
The system recently launched under the trade name Cleaner Vac thrombectomy system 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 pulmonary embolism.
“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,” says George Leondis, president and CEO of Argon Medical, in a release.
Photo caption: Cleaner Vac thrombectomy system
Photo credit: Argon Medical
