Penumbra Launches 5Max Reperfusion Catheter

August 22, 2012—Penumbra, Inc. (Alameda, CA) announced the launch of the 5Max reperfusion catheter for clot removal in patients experiencing acute ischemic stroke. Penumbra's Max system applies direct aspiration on the occlusion to optimize thrombus removal without the need for dual operators or the use of a large proximal balloon guide.

The company describes the 5Max as featuring a tapered design that allows for a lower-profile, flexible distal section to optimize navigation and a larger proximal section for aspiration power that is equivalent to a 0.062-inch lumen of the same length. The device's tapered lumen also allows easy delivery of adjunctive therapies, eliminating the need for reaccess.

As with all of the devices included in the company's Max line of reperfusion catheters, the 5Max incorporates a polymer and nitinol coil reinforcement design at the distal tip to enable easy tracking through tortuous vessels. The Penumbra system, including the new Max system, can be used to open the blood vessels of patients with acute ischemic stroke within 8 hours of symptom onset. Advanced stroke centers can use the Max system with or without intravenous clot-busting drugs, advised the company.

Quill Turk, DO, commented on the new device in Penumbra's press release. Dr. Turk is Associate Professor of Radiology and Director of the Neurointerventional Division at the Medical University of South Carolina in Charleston.

“The tapered lumen of the 5Max has great aspiration power for quick and efficient clot removal,” stated Dr. Turk. “The new 5Max design allows easy intracranial access with a large-bore versatile catheter for stroke intervention. When beginning a clot removal procedure, the 5Max allows me to access the clot and reliably open the vessel. If needed, adjunctive devices can be introduced through the 5Max easily while retaining the benefit of direct aspiration,” he added. “I feel that 5Max provides the widest range of therapeutic options to treat an often challenging disease.”

As noted in the company's press release, interim results from the START trial of the Penumbra system technology showed that 48.1% (37/77) of patients who were treated with the technology had a modified Rankin score of ≤ 2 at 90 days follow-up, indicating a return to independent living. The interim START data were reported at the 2012 International Stroke Conference last February in New Orleans.