Penumbra (NYSE:PEN) announced today that the Cheetah clinical study for its Indigo CAT RX catheter met its primary endpoint.
Alameda, California-based Penumbra’s Indigo catheter system demonstrated 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 company presented the results of the Cheetah study at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference in Orlando, according to a news release.
Penumbra’s Cheetah study enrolled 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI. The trial observed 99.5% of patients experience TIMI thrombus grade 0 after CAT RX and PCI.
Additionally, 97.5% of patients had thrombolysis in myocardial infarction (TIMI) flow grade 3 after CAT RX and PCI, with TIMI increasing significantly from 16.6% at baseline to 85% after CAT RX alone. Finally, 99.8% of patients experienced enhance myocardial blush grade after CAT RX and PCI while zero device-related serious adverse events occurred.
“These results are very promising as they demonstrate the significant benefits and safety of continuous powered aspiration thrombectomy for those patients with high thrombus burden, which can often be life-threatening,” National Principal Investigator Dr. S. Jay Mathews, Director of the Cardiac Catheterization Laboratory at Manatee Memorial Hospital in Bradenton, Florida, said in the release. “After only one pass with Penumbra’s CAT RX, we were pleased to see restoration of blood flow and perfusion when used upfront in acute coronary syndrome interventions.”
Penumbra said that the CAT RX procedure took only 69 seconds to complete in the study and enhanced visualization of target lesions by approximately 95% with low rates of distal embolization.
“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,” Penumbra CMO Dr. James F. Benenati said. “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.”