Penumbra (NYSE:PEN) announced today that initial data support the use of its RED reperfusion catheters and the Penumbra System.
Alameda, California-based Penumbra presented results from the initial Insight Registry for the RED reperfusion catheters and the sub-analyses of the Complete study for the Penumbra system at the 2022 World Federation of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto, Japan.
The company said in a news release that the Insight Registry evaluating RED in the removal of all clot types in 161 acute ischemic stroke (AIS) patients demonstrated that 68.9% had successful first-pass revascularization and 97% had successful revascularization after final angiogram.
“The initial data from our Insight Registry is very promising. With such a high first pass rate, Penumbra’s RED catheters can restore blood flow much quicker, which we know can lead to improved outcomes for patients,” said Sandra Lesenfants, president of interventional at Penumbra. “Penumbra’s focus has always been to help as many people as we can, and this data demonstrates that our latest technology is indeed making a positive impact.”
Penumbra’s Complete study demonstrated that the Penumbra System is effective for treating AIS patients with tandem lesions, as well as patients who are considered in the late window of treatment.
Findings included patients with anterior circulation tandem lesions with stenosis greater than 50% treated with Penumbra System resulted in successful revascularization, while late window patients achieved successful revascularization with the use of the Penumbra System in 83.2% of cases, with a 90-day good functional outcome rate of 55.4%. No device-related adverse events were observed.
“Mechanical aspiration thrombectomy is becoming an increasingly important option for physicians treating acute ischemic stroke, especially patients with more complicated cases,” said Dr. Osama Zaida, the national principal investigator of the Penumbra Complete study. “Oftentimes, patients that presented late or have tandem lesions (15% of MT cases) are difficult to treat. However, the data showed the Penumbra System delivered good functional outcomes and low 90-day mortality rates for these patients, which compared favorably to other options.”