Penumbra’s Red Reperfusion Catheters Are Approved in Europe to Treat Stroke

September 7, 2022—Penumbra, Inc. announced that its Red reperfusion catheters have received CE Mark approval and are now commercially available in Europe. The catheters are part of the Penumbra System, which is a fully integrated mechanical aspiration thrombectomy system designed to restore blood flow in acute ischemic stroke (AIS) patients.

According to the company, the Red family of catheters’ trackability and aspiration are designed to address a wide range of large vessel occlusion. The catheters feature the company’s Redglide technology, which enhances the trackability of the catheters as they navigate the challenging vessel anatomy of the brain while maximizing aspiration efficiency to remove blood clots. Additionally, the Red catheters have a full-length polytetrafluoroethylene liner designed to maintain their true lumen size under powerful vacuum.

“When addressing stroke, our goal is to remove the blood clot as quickly as possible for patients to have the best outcome,” commented Saleh Lamin, MD, in Penumbra’s press release.

Dr. Lamin, who is a neurointerventionalist at Queen Elizabeth Hospital in Birmingham, United Kingdom, continued, “With Red catheters, we will be able to get up to the clot quickly and efficiently remove it, most of the time within a single pass. Restoring blood flow promptly is key as it is associated with less damage to the brain and better outcomes.”

Penumbra noted that initial data from the INSIGHT Registry showed Red reperfusion catheters were successful in removing all clot types with a significant first-pass rate.

The data from 161 AIS patients showed 68.9% successful first-pass revascularization (modified thrombolysis in cerebral infarction [mTICI] ≥ 2b-3), and 97% successful revascularization after final angiogram through site-reported findings. Final mTICI ≥ 2b-3 scores were reported in 98.1% of patients with firm-red clots and in 100% of patients with other clot types.

The company previously announced that the INSIGHT data were presented at the WFITN 2022, the 16th congress of the World Federation of Interventional and Therapeutic Neuroradiology held August 21-25 in Kyoto, Japan.