Penumbra reports improved outcomes in pulmonary embolism trial
Penumbra Inc. (NYSE: PEN) announced 90-day results from its STORM-PE randomized controlled trial showing patients with acute intermediate-high risk pulmonary embolism achieved better functional outcomes when treated with computer assisted vacuum thrombectomy plus anticoagulation compared to anticoagulation alone.
The trial enrolled 100 patients across 22 international sites. Patients treated with Penumbra's computer assisted vacuum thrombectomy technology plus anticoagulation walked significantly longer distances during six-minute walk tests (479 meters versus 368 meters) and achieved near-normal walking capacity at 94% of predicted distance versus 75.2% for anticoagulation alone.
The combination treatment group also showed 97% of patients experienced no physical limitations based on New York Heart Association Functional Class Scale compared to 76% in the anticoagulation-only group. Patients returned to pre-pulmonary embolism functional status while the anticoagulation-only group did not.
Safety rates through 90 days were comparable between both treatment groups, with no device-related mortality, no additional pulmonary embolism-related mortality past seven days, and no difference in symptomatic pulmonary embolism recurrence, according to the company's press release.
The data were presented at the Society of Interventional Radiology Annual Scientific Meeting. Pulmonary embolism affects an estimated 900,000 cases annually in the United States and represents the third leading cause of cardiovascular death after heart attack and stroke.
STORM-PE was conducted in partnership with The PERT Consortium and evaluated computer assisted vacuum thrombectomy using Penumbra's Lightning Flash technology plus anticoagulation versus anticoagulation alone for treating acute intermediate-high risk pulmonary embolism.
