Penumbra Launches Max System Reperfusion Catheters for Treating Acute Ischemic Stroke


June 18, 2012—Penumbra, Inc. (Alameda, CA) announced the launch of its Max system of reperfusion catheters for removal of clots in patients experiencing acute ischemic stroke. 


The company stated that as an addition to its family of aspiration thrombectomy devices, the Max system neurointerventional devices allow for a fast, simplified cerebral thrombectomy procedure conducted by a single operator with over-the-wire delivery and without the need for a large proximal balloon guide. 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. The Max system can be used with intravenous thrombolytics or without them when those drugs cannot be used.
 

As detailed in the company's press announcement, the Max system includes two specialized aspiration catheters, 4 Max and 3 Max, that incorporate a new polymer and a new nitinol reinforcement design at the distal tip, enabling a single operator to track the catheters through the tortuous vessels leading to a target lesion in the brain over a standard 0.014-inch guidewire. These catheters also incorporate the tapering and larger proximal diameters used in Penumbra's reperfusion catheter 054.


Penumbra noted that interim results from the START trial of the Penumbra system technology, which were reported at the 2012 International Stroke Conference, 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.
 

Rishi Gupta, MD, who is Director of the Acute Stroke Network–Marcus Stroke & Neuroscience Center at Grady Health System in Atlanta, Georgia, commented on the Max system in the company's press release. Dr. Gupta said, “The Max system represents a significant advancement in stroke treatment. The ability to quickly and easily deliver a 4 Max catheter over a standard guidewire to the arteries of the brain gives us more time to concentrate on treating the stroke. Likewise, the larger proximal lumen improves aspiration power, giving us efficient removal of the clot similar to the ability we had with the reperfusion catheter 054. These two features result in a combination of ease of use, cost savings, and rapid reperfusion that make it our front-line device for stroke patients at Grady.”