PRISM Supports Safety and Efficacy of Penumbra's Indigo Mechanical Aspiration System

April 5, 2016—Penumbra, Inc. presented final results of its multicenter PRISM study on the company's Indigo system at SIR 2016, the Society for Interventional Radiology’s annual meeting held April 2–7 in Vancouver, British Columbia. Also at SIR, Penumbra announced the launch of the Lantern low-profile, high-flow microcatheter, which is designed to assist in the delivery of diagnostic agents and therapeutic devices such as contrast media and occlusion coils.

The PRISM study was designed to assess the safety and efficacy of the Indigo mechanical aspiration system for the removal of blood clots in the peripheral vasculature.

According to the company, the final results showed that the Indigo system proved safe and effective in restoration of flow to patients suffering from peripheral occlusions relating to events of acute ischemia, failed thrombolysis, and distal emboli as a complication of previous interventions. The PRISM study also demonstrated thromboaspiration to be safe and effective in revascularization of peripheral and visceral arterial occlusions. These results support the utility of this system across a wide range of applications in the peripheral vasculature, concluded the investigators. 

As summarized in the SIR abstract of the presentation, the PRISM trial enrolled 83 patients who received aspiration thrombectomy using the Penumbra Indigo system. Median time from symptom onset to aspiration thrombectomy was 4 days in a populace with a median age of 69 years. At presentation, angiographic thrombolysis in myocardial infarction (TIMI) score 0–1 were reported for 94.9% (75/79) of patients. Before thromboaspiration, 27.2% (22/81) of patients received lytic therapy, 13.6% (11/81) received mechanical intervention, 8.6% received both combined therapies, and 50.6% (41/81) were treated with aspiration thrombectomy using the Penumbra Indigo system as frontline therapy. Vessel patency, defined as angiographic TIMI score 2–3, was observed in 89% (73/82) of patients immediately following aspiration thrombectomy, and in 96.3% (78/81) of patients after all interventions. Serious adverse events were reported in 10 patients; none were device related.