Penumbra’s Red 62 Reperfusion Catheter Cleared by FDA

June 23, 2021—Penumbra, Inc. announced FDA 510(k) clearance and commercial availability of the Red 62 reperfusion catheter, an addition to the Penumbra system for mechanical thrombectomy.

According to the company, Red 62 is designed to navigate complex distal vessel anatomy and deliver powerful aspiration with the Penumbra Engine for the removal of blood clots in acute ischemic stroke patients with large vessel occlusions. The device has a low diameter profile and extended length to reach target vessels.

“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,” commented Kurt Reuland, MD, in the company’s press 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.” Dr. Reuland is an interventional neuroradiologist at Christus Trinity Mother Frances Health System in Tyler, Texas.

The Penumbra system, which is intended for mechanical thrombectomy in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions, includes reperfusion catheters, a three-dimensional revascularization device, and the Engine aspiration source and other accessories, stated the company.