New Data Demonstrates Safety and Performance of Continuous Aspiration Thrombectomy with Penumbra’s Indigo® System CAT™ RX Catheter in High-Risk Patients with Acute Coronary Syndrome

Rhea-AI Summary

Penumbra, Inc. (NYSE: PEN) announced positive results from the CHEETAH clinical study of its CAT RX Catheter at the TCT conference. The study achieved high rates of blood clot removal and restored blood flow in patients with high thrombus burden. Key findings included a 99.5% reduction in TIMI thrombus grade and 97.5% of patients achieving TIMI flow grade 3 post-treatment. No serious device-related adverse events were reported. The study emphasizes the effectiveness and safety of continuous powered aspiration thrombectomy in acute coronary syndrome interventions.

Positive

• 99.5% of patients achieved TIMI thrombus grade 0 after CAT RX and PCI.
• 97.5% of patients had TIMI flow grade 3 after treatment.
• 99.8% achieved myocardial blush grade 3 post-treatment.
• No serious adverse events associated with CAT RX.

Negative

• None.

• CAT RX established high rates of blood clot removal, blood flow restoration and myocardial perfusion normalization
• No serious adverse events associated with the use of sustained power aspiration
• Results of the CHEETAH clinical study were presented at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference

ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that the CHEETAH clinical study of its Indigo^® System CAT™ RX Catheter successfully met the 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 the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference in Orlando.

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. (Graphic: Business Wire)

“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,” said National Principal Investigator S. Jay Mathews, M.D., M.S., Director, Cardiac Catheterization Laboratory, Manatee Memorial Hospital in Bradenton, FL. “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.”

The CHEETAH clinical study enrolled 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI. Notable findings include:

• Significant reduction in Thrombolysis in Myocardial Infarction (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’ 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 myocardial blush grade (MBG): 99.8% of patients achieved MBG 3 after CAT RX and PCI.
• No device-related serious adverse events occurred.

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.

“This is the first large study to demonstrate the significant benefits of continuous aspiration,” said Dr. Sahil Parikh, associate professor of medicine at Columbia University Irving Medical Center in New York. “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. 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.”

In the study, the CAT RX procedure took about 69 seconds to complete. It enhanced visualization of target lesions by approximately 95% and had 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,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “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.”

About the CHEETAH Study

The CHEETAH study, a prospective, single-arm, multicenter study of continuous mechanical aspiration thrombectomy with CAT RX prior to PCI, evaluated 400 patients at 25 centers in the U.S. 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 was a composite MACE of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure within 30 days. Key secondary endpoints included Core Lab adjudicated final TIMI flow and thrombus grade, MBG, distal embolization rate, incidence of device-related serious adverse events (SAEs) and stroke within 30 days. All safety events were independently adjudicated.

About Penumbra

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.

Important Safety Information

Additional information about Penumbra’s products can be located on Penumbra’s website at http://www.penumbrainc.com/healthcare-professionals. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Risk information can be found here.

Forward-Looking Statements

Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on February 23, 2021. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

Source: Penumbra, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211105005287/en/

Jennifer Heth

Penumbra, Inc

jheth@pennumbrainc.com

213-840-0418

Betsy Merryman

Merryman Communications

betsy@merrymancommunications.com

310-560-8176

Source: Penumbra, Inc.

FAQ

What were the results of the CHEETAH study for Penumbra's CAT RX Catheter?

The CHEETAH study showed that 99.5% of patients achieved TIMI thrombus grade 0 and 97.5% achieved TIMI flow grade 3 after using the CAT RX Catheter.

When were the CHEETAH study results presented by Penumbra?

The results of the CHEETAH clinical study were presented at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference.

What is the significance of the CAT RX results for Penumbra?

The results demonstrate high efficacy in blood clot removal and restoring blood flow, indicating significant benefits for patients with high thrombus burden.

What is the stock symbol for Penumbra?

The stock symbol for Penumbra is PEN.

Were there any serious adverse events reported in the CHEETAH study?

No serious device-related adverse events were reported during the CHEETAH study.