The Indigo thrombectomy system safely revascularized peripheral and visceral arterial occlusions, according to final results from the small PRISM trial.
Immediately following aspiration, Thrombolysis In Myocardial Infarction (TIMI) Grade Flow was restored in most patients in whom it was used. TIMI scores climbed from 0-1 in 98.8% of subjects beforehand to 2-3 in 88.1% afterward.
By 24 hours, serious adverse events had occurred in 7.1% of cases. None of the events were device-related, , of Sanford Health in Fargo, N.D., told the audience at the Society of Interventional Radiology meeting in Vancouver.
"The Penumbra/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," he concluded.
The PRISM investigation included 85 patients who received mechanical aspiration with Penumbra's Indigo device.
Used as first-line therapy in 50.6% of patients, the device was also used in those who had previously received thrombolytic therapy (16.5%), other mechanical interventions (17.6%), and combined therapies (15.3%).
More than half (54.2%) of occlusion sites were located in the popliteal or tibial arteries, with another 34.1% situated in the femoral vessels.
Playing to the device's advantage is its suitability for treating "much larger vessels," Teigen told MedPage Today. With 6- and 8-French catheters, he and his colleagues were able to treat thrombi even in renal vessels.
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Disclosures
Teigen reported consulting for Cordis.
Primary Source
Society of Interventional Radiology 2016
Teigen C, et al "Penumbra/Indigo System provides a novel aspiration thrombectomy tool in treatment of peripheral and visceral arterial occlusions -- final results of the PRISM trial" SIR 2016.