Penumbra adds MAX System of Reperfusion Catheters to family of aspiration thrombectomy devices

The Penumbra System^® family of aspiration thrombectomy devices now includes the MAX System of Reperfusion Catheters for removal of clots in patients experiencing acute ischemic stroke. The MAX System neuro-interventional devices offer a fast, simplified cerebral thrombectomy procedure with single-operator, over-the-wire delivery without the need for a large proximal balloon guide.

The MAX System includes two specialized aspiration catheters, 4MAX and 3MAX 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" guidewire. These new catheters also incorporate the tapering, larger proximal diameters pioneered by Penumbra's industry leading Reperfusion Catheter 054, enabling the MAX System to achieve similar effectiveness and rapid reperfusion times.

"The MAX System represents a significant advancement in stroke treatment. The ability to quickly and easily deliver a 4MAX 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," said Rishi Gupta MD, Director, Acute Stroke Network - Marcus Stroke & Neuroscience Center at Grady Health System in Atlanta, Georgia.

The Penumbra System technology has shown superior outcomes in the recent START Trial. Interim results reported at the 2012 International Stroke Conference showed 48.1% (37/77) of patients had a modified Rankin Score (mRS) of ≤ 2 at 90 days follow-up, indicating a return to independent life. This is the highest rate of good neurological outcomes in any prospective, multicenter, core-lab adjudicated study of interventional stroke treatment to date.

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 may use the MAX System in conjunction with intravenous clot-busting drugs, or when those drugs can't be used.