Penumbra’s RED Reperfusion Catheters Get CE Mark

Physicians in Europe now have access to Penumbra’s latest stroke technology for mechanical thrombectomy. RED® reperfusion catheters are designed with optimized trackability and aspiration efficiency to help navigate the complex anatomy of the brain and deliver powerful aspiration for the removal of blood clots. Initial INSIGHT Registry data presented at WFITN demonstrated RED catheters were highly effective in removing all clot types with an impressive 68.9% mTICI > 2b-3 overall first pass effect rate.

Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that its RED® Reperfusion Catheters have secured CE Mark (Conformité Européenne) and are now commercially available in Europe. The catheters are part of the company’s Penumbra System®, which is a fully integrated mechanical aspiration thrombectomy system designed to restore blood flow in acute ischemic stroke (AIS) patients.

“When addressing stroke, our goal is to remove the blood clot as quickly as possible for patients to have the best outcome,” said Saleh Lamin, M.D., neurointerventionalist, Queen Elizabeth Hospital, Birmingham, UK. “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.”

The RED family of catheters is engineered with the latest technology in trackability and aspiration to address a wide range of large vessel occlusions via mechanical aspiration thrombectomy. The RED catheters feature REDglide™ technology, which enhances the trackability of the catheters as they navigate the challenging vessel anatomy of the brain while also maximizing aspiration efficiency to remove blood clots. Additionally, the RED catheters have a full-length PTFE liner designed to maintain their true lumen size under powerful vacuum.

“Penumbra’s commitment to advancing technology allows us to have one of the most expansive aspiration stroke portfolios on the market, enabling physicians to have the latest innovations with the most options to provide the best care to their patients,” said Joan Kristensen, vice president and head of the Europe, Middle East and Africa region for Penumbra, Inc. “With enhanced trackability and powerful aspiration, initial data has shown that Penumbra’s RED catheters can restore blood flow quickly across all clot types, which would potentially have a significant impact on patient outcomes here in Europe.”

Initial INSIGHT Registry data presented in August at the World Federation of Interventional and Therapeutic Neuroradiology (WFITN) showed Penumbra’s 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 (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.

“Expanding access to our leading RED catheters in Europe enhances Penumbra’s ability to support more physicians and patients around the world,” said Sandra Lesenfants, president of interventional at Penumbra, Inc. “As we continue to pioneer interventional technology, our commitment is to improve care so patients, especially those with serious conditions such as stroke, can return home quickly and live full lives.”

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