Penumbra’s Indigo System CAT RX Catheter Studied in CHEETAH for High-Risk ACS Patients

November 5, 2021—Penumbra, Inc. announced that the CHEETAH clinical study of its Indigo system CAT RX continuous aspiration thrombectomy catheter successfully met the study’s primary endpoint and 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 results were presented at TCT 2021, the 33rd annual scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida.

According to the company, CHEETAH is a prospective, single-arm, multicenter study of continuous mechanical aspiration thrombectomy with CAT RX before PCI. The study evaluated 400 patients at 25 centers in the United States. Adults presenting within 12 hours of symptom onset, with target lesions located in a native coronary artery and high thrombus burden were eligible for enrollment.

The primary endpoint of major adverse cardiovascular events, a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure within 30 days.

Key secondary endpoints included core lab adjudicated final thrombolysis in myocardial infarction (TIMI) flow and thrombus grade, myocardial blush grade (MBG), distal embolization rate, incidence of device related serious adverse events, and stroke within 30 days. All safety events were independently adjudicated.

As summarized by the company, the findings include

• Significant reduction in TIMI thrombus grade. 99.5% of patients achieved TIMI thrombus grade 0 after CAT RX and PCI.
• Improved TIMI flow grade. 97.5% of patients showed TIMI flow grade 3 after CAT RX and PCI. TIMI 2-3 increased significantly from 16.6% at baseline to 85% after CAT RX alone.
• Enhanced MBG. 99.8% of patients achieved MBG 3 after CAT RX and PCI.
• No device-related serious adverse events occurred.

In the study, the CAT RX procedure took approximately 69 seconds to complete. Visualization of target lesions was enhanced by approximately 95% and resulted in low rates of distal embolization.

“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,” commented CHEETAH National Principal Investigator S. Jay Mathews, MD, in the company’s press 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 [ACS] interventions.” Dr. Mathews is Director, Cardiac Catheterization Laboratory, Manatee Memorial Hospital in Bradenton, Florida.

Sahil Parikh, MD, associate professor of medicine at Columbia University Irving Medical Center in New York, New York, added, “This is the first large study to demonstrate the significant benefits of continuous aspiration. Such immediate and robust reperfusion with CAT RX is encouraging as physicians are in a race against time to safely restore blood flow in heart attack patients.”

Dr. Parikh continued, “The CHEETAH study suggests that CAT RX power aspiration is both safe and effective in a high-risk coronary patient population. This data highlights the importance of innovation in technology and hopefully will lead to further improvements in meaningful clinical outcomes for our patients.”

As part of the Indigo aspiration system, the Indigo CAT RX aspiration catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature, advised Penumbra.