Penumbra (NYSE:PEN) today said its Red 62 reperfusion catheter has received FDA 510(k) clearance.
Alameda, Calif.-based Penumbra designed the catheter to navigate complex distal vessel anatomy and deliver powerful aspiration with its Penumbra Engine to remove blood clots in acute ischemic stroke patients with large vessel occlusions.
“In my initial experience with Red 62, I am impressed by how responsive the catheter is as I navigate through the intricate vessels of the brain,” Dr. Kurt Reuland, an interventional neuroradiologist at Christus Trinity Mother Frances Health System in Tyler, Texas, said in a news release. “The performance and length of Red 62 enable me to address a broader group of patients using aspiration thrombectomy to remove blood clots and improve my patients’ health outcomes.”
Red 62 is designed to address large vessel occlusions that are located in more challenging distal vessel anatomy. It has a low diameter profile and extended length to help reach target vessels.
“With the continued success of aspiration thrombectomy, physicians asked us to address navigation in more challenging distal vessels. Red 62 builds on our previous design generations, continuing our efforts to maximize both trackability and aspiration power,” Penumbra president and CEO Adam Elsesser said. “This is the first catheter in the Red series, which will provide physicians with the broadest portfolio of aspiration thrombectomy solutions for stroke management while also focusing on reducing overall healthcare costs.”
