Penumbra (NYSE:PEN) announced today that it received the CE mark for its Penumbra RED reperfusion catheter and began the European launch.
Alameda, California-based Penumbra designed its RED reperfusion catheter for the removal of all clot types in acute ischemic stroke (AIS) patients.
The catheters are part of the Penumbra System — a fully integrated mechanical aspiration thrombectomy system — for restoring blood flow in AIS patients. Recent data presented by the company demonstrated successful revascularization using the system.
“When addressing stroke, our goal is to remove the blood clot as quickly as possible for patients to have the best outcome,” neurointerventionalist Dr. Saleh Lamin at Queen Elizabeth Hospital in Birmingham, U.K., said in a news release. “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.”
RED catheters feature REDglide technology, which enhances the trackability of the catheters. It also maximizes the aspiration efficiency to remove blood clots as they navigate the challenging vessel anatomy of the brain. RED catheters also 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, VP and head of EMEA for Penumbra, in the news release. “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.”
The data from the Insight Registry evaluating RED in the removal of all clot types in 161 acute ischemic stroke (AIS) patients demonstrated that 68.9% had successful first-pass revascularization and 97% had successful revascularization after final angiogram.
“Expanding access to our leading RED catheters in Europe enhances Penumbra’s ability to support more physicians and patients around the world,” Penumbra Interventional President Sandra Lesenfants said in the release. “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.”