In the study, Penumbra’s device has indicated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden
Penumbra’s Indigo system CAT RX catheter has achieved primary endpoint in Cheetah trial. (Credit: Business Wire)
Healthcare company Penumbra announced that its Indigo system CAT RX catheter has achieved the primary endpoint in the Cheetah clinical study.
The trial has shown the safety and performance of continuous aspiration thrombectomy with Indigo system CAT RX catheter in high-risk patients with acute coronary syndrome.
In the study, Penumbra’s device has indicated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden.
The prospective, single-arm and multicentre study recruited 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI.
The trial’s crucial findings consist of a significant reduction in thrombolysis in myocardial infarction (TIMI) thrombus grade and improved TIMI flow grade, enhanced myocardial blush grade (MBG) and no device-related serious adverse events.
Penumbra stated that the CAT RX procedure took round 69 seconds to complete in the study and it allowed to enhance visualisation of target lesions by around 95%, as well as indicated low rates of distal embolisation.
Penumbra chief medical officer Dr James Benenati said: “The CHEETAH study highlights the safety and performance of CAT RX for removing blood clots in the coronary arteries and restoring blood flow in a short period of time.
“The findings suggest that continuous aspiration should be a key consideration given that removing the blood clots improves perfusion to the heart and also allows for more precise visualization of coronary lesions potentially leading to improving patient outcomes.”
Under the Indigo Aspiration System, the Indigo CAT RX Aspiration catheters and Indigo Separator 4 are used to remove fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The company has assessed the patients at 25 centers in the US.
The trial’s primary endpoint was a composite MACE of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure within 30 days.
Its main secondary endpoints consist of core lab adjudicated final TIMI flow and thrombus grade, MBG, distal embolisation rate, incidence of device-related serious adverse events (SAEs) and stroke within 30 days.