RT’s Three Key Takeaways:
- Research Goals to Enhance PE Therapy: The CLEAN-PE research is evaluating the protection and efficacy of the Cleaner Professional thrombectomy system for treating pulmonary embolism, enrolling over 100 sufferers throughout the U.S.
- Gadget Gives Novel Method: The Cleaner Professional thrombectomy system makes use of a catheter-based aspiration technique designed to take away blood clots shortly and effectively, probably bettering affected person outcomes.
- Excessive Stakes for Life-Threatening Situation: Pulmonary embolism impacts roughly 900,000 individuals yearly within the US, with a mortality price of as much as 30% if untreated.
Argon Medical Units introduced the primary affected person enrollment within the CLEAN-PE research, which goals to guage the protection and efficacy of the Cleaner Professional thrombectomy system for eradicating blood clots from the lungs in sufferers recognized with pulmonary embolism (PE).
CLEAN-PE is estimated to enroll over 100 sufferers at varied hospital amenities throughout the USA.
The multicenter research is led by nationwide principal investigator Aravinda Nanjundappa, MD, an interventional heart specialist on the Cleveland Clinic in Cleveland, Ohio. The primary affected person process came about at Buffalo Basic Medical Middle in Buffalo, New York, by David M. Zlotnick, MD, an interventional heart specialist at Buffalo Basic Medical Middle.
PE happens when a blood clot migrates to the lungs and restricts blood stream. This situation is life-threatening with a mortality price as much as 30%, if left untreated. Roughly 900,000 individuals in the USA alone are affected by the situation annually.
“We’re proud to enroll the primary affected person within the CLEAN-PE research using the Cleaner professional thrombectomy system. Distinctive therapy choices are rising for the administration of this affected person inhabitants. We’re excited to guage a brand new gadget for sufferers recognized with pulmonary embolism,” says Zlotnick in a launch.
The Cleaner Professional thrombectomy system is a catheter-based aspiration thrombectomy gadget comprised of a user-controlled handpiece, a large-bore aspiration catheter, a dilator, and a single-use aspiration pump and canister.
The system lately launched below the commerce title Cleaner Vac thrombectomy system for the removing of recent, comfortable thrombi and emboli from the vessels of the peripheral venous vasculature. The Cleaner Vac thrombectomy system will not be at present cleared by the FDA to be used within the pulmonary vasculature for treating pulmonary embolism.
“Knowledge signifies that pulmonary embolism mortality charges have elevated within the final decade. We intention to assist physicians enhance affected person outcomes by growing new options that allow faster and simpler PE interventions. Enrolling the primary affected person into the CLEAN-PE research is a monumental step ahead for the answer we designed, and we’re excited to find the distinction The Cleaner Vac thrombectomy system could make for sufferers with this life-threatening situation,” says George Leondis, president and CEO of Argon Medical, in a launch.
Picture caption: Cleaner Vac thrombectomy system
Picture credit score: Argon Medical
