Initial Data Presented for Penumbra’s INSIGHT Registry and Subanalysis of the COMPLETE Study for Patients With Acute Ischemic Stroke

August 25, 2022—Penumbra, Inc. announced that the latest data from its INSIGHT registry, which is evaluating the RED reperfusion catheter in patients with acute ischemic stroke (AIS), and data from a subanalysis of the COMPLETE study, which is reviewing the Penumbra System, were presented at the 2022 World Federation of Interventional and Therapeutic Neuroradiology held August 21-25 in Kyoto, Japan.

According to the company, the INSIGHT registry data showed that the RED catheter was successful at removing all clot types. In 161 patients with AIS, 68.9% had a successful first-pass revascularization (modified thrombolysis in cerebral infarction [mTICI] scores ≥ 2b-3) and 97% had successful revascularization after final angiography through site-reported findings. Also, final mTICI scores ≥ 2b to 3 were reported in 98.1% of patients with firm-red clots and in 100% of patients with other clot types.

Penumbra noted that the high first-pass rate observed in the multicenter, postmarket INSIGHT registry suggests that the RED catheter may restore blood flow much quicker, which may lead to improved outcomes for patients.

Elsewhere, data from a subanalysis of the COMPLETE study reviewing tandem lesions and late window of treatment for patients with AIS showed that aspiration thrombectomy using the Penumbra System restored blood flow and had improved functional outcomes at 90 days.

“Mechanical aspiration thrombectomy is becoming an increasingly important option for physicians treating AIS, especially patients with more complicated cases,” commented Osama Zaidat, MD, the National Principal Investigator of the COMPLETE study, in Penumbra’s press release.

He continued, “Oftentimes, patients that presented late or have tandem lesions (15% of mechanical thrombectomy 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.”

 COMPLETE is a global, prospective, multicenter postmarket study assessing the performance of the company’s Penumbra System. The core lab–adjudicated findings include:

• Patients with anterior circulation tandem lesions with stenosis > 50% treated with the Penumbra System resulted in successful revascularization: 89% of patients achieved mTICI scores of 2b to 3, and nearly 64% of patients achieved 90-day modified Rankin score of 0 to 2.  
• Late-window patients achieved successful revascularization with use of the Penumbra System in 83.2% of cases, with a 90-day good functional outcome rate of 55.4%. Additionally, there were no device-related adverse events observed.