Penumbra’s Indigo System CAT RX Catheter Launched in Europe

January 16, 2024—Penumbra, Inc. announced it has secured CE Mark approval for its Indigo system CAT RX continuous aspiration thrombectomy catheter for the treatment of acute coronary syndrome (ACS). The device is now commercially available in Europe.

According to the company, the Indigo system CAT RX is designed to navigate tortuous coronary anatomy while maintaining sustained mechanical aspiration with the Penumbra Engine. It is intended to address the limitations of traditional ACS management strategies, as syringe aspiration shows diminished vacuum after fluid enters the system.

Penumbra stated that the CHEETAH study of the Indigo system CAT RX demonstrated high rates of blood clot removal, blood flow restoration, and myocardial perfusion in conjunction with percutaneous coronary intervention in patients with high thrombus burden. Primary and key secondary endpoint results from CHEETAH were presented at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held in Orlando, Florida, on November 4-6, 2021.

“The CHEETAH findings suggest that continuous aspiration with CAT RX should be a key consideration when high thrombus burden plaque is encountered, given that removing the thrombus improves perfusion,” commented Penumbra’s Chief Medical Officer James F. Benenati, MD, in the company’s press release. “CAT RX has demonstrated a high degree of safety while maximizing effectiveness in removing thrombus. We believe this can lead to better outcomes for the patient.”