Penumbra’s CAVT With Anticoagulation Studied in STORM-PE

October 27, 2025—Penumbra, Inc. announced that the results of the STORM-PE randomized controlled trial showed that mechanical thrombectomy using the company’s computer assisted vacuum thrombectomy (CAVT) system with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate–high-risk pulmonary embolism (PE).

The data were presented by Robert Lookstein, MD, during a late-breaking clinical science session at the TCT 2025 scientific symposium. Dr. Lookstein and Rachel Rosovsky, MD, are Coglobal Principal Investigators of STORM-PE.

According to Penumbra, the STORM-PE trial enrolled 100 patients across 22 international sites.

The company reported that patients treated with CAVT demonstrated a greater reduction in right-to-left ventricular (RV/LV) diameter ratio within 48 hours (mean reduction, 0.52 vs 0.24; P < .001). Additionally, approximately 80% of patients had a positive treatment effect with CAVT, which was significantly greater than in patients who received anticoagulation alone (78.3% vs 51.9%; P = .011), reflecting rapid hemodynamic recovery.

The rate of major adverse events within 7 days—including a composite of PE-related mortality, recurrent PE, clinical deterioration requiring rescue therapy, and major bleeding—was comparable between groups (4.3% [2/47] with CAVT vs 7.5% [4/53] with anticoagulation alone), stated Penumbra.

“These findings mark a pivotal step in advancing care for PE, providing the strongest evidence to date that advanced therapy with CAVT can rapidly and safely improve recovery of the right heart compared to conventional anticoagulation therapy,” commented Dr. Lookstein. “STORM-PE supports the role of CAVT as a more effective therapeutic option for intermediate-high-risk patients and will evolve the paradigm of care by delivering rapid relief with a comparable safety profile to anticoagulation alone.”

Dr. Rosovsky added, “What’s particularly compelling is that a significantly greater portion of patients treated with CAVT achieved normalization of RV/LV ratio within 48 hours—a critical indicator of right heart recovery—without an increase in complications. These findings represent a meaningful advancement in optimizing early interventions in patients with intermediate-high-risk PE, and we look forward to exploring how changes in RV/LV ratio correlate with other clinical and functional outcomes.”

The company advised that additional results from the STORM-PE trial will be presented at the upcoming VEINS and VIVA conference, held November 1-5 in Las Vegas, Nevada.