Primary Results From STORM-PE RCT Presented for Penumbra’s CAVT System

November 3, 2025—Penumbra, Inc. announced that results of the STORM-PE randomized controlled trial (RCT) were presented at VIVA 2025, the Vascular Interventional Advances conference. Additionally, the primary results from STORM-PE were published by Robert A. Lookstein, MD, et al online in Circulation.

The study found that the use of the company’s computer-assisted vacuum thrombectomy (CAVT) system with anticoagulation achieved significantly greater improvements in thrombus burden reduction, heart rate, oxygen requirement, and functional outcomes compared to anticoagulation alone in patients with acute intermediate–high-risk pulmonary embolism (PE).

Dr. Lookstein and Rachel Rosovsky, MD, are Coglobal Principal Investigators of the STORM-PE RCT.

The data at VIVA add to the STORM-PE findings that were presented by Dr. Lookstein at the TCT 2025 scientific symposium in October, noted the company.

As outlined in Penumbra’s press release, patients treated with CAVT plus anticoagulation experienced the following:

• Significantly lowered thrombus burden at 48 hours, with a 2.7 times larger reduction in refined modified Miller score (42.1% vs 15.6% relative reduction; P < .001).
• Early physiological recovery with significantly lower heart rate (80 vs 86.4 bpm; P = .022) and less tachycardia (heart rate > 100, 2.2% vs 20%; P = .008), reduced supplemental oxygen requirements (0.5 vs 1.4 L/min; P = .027), and a lower NEWS2 risk of clinical deterioration (1.8 vs 2.7; P = .034) at 48 hours.
• 2.2 times greater likelihood of progressing toward recovery of functional status, based on post venous thromboembolism functional status from pre-PE event to discharge (P = .032).
• Significantly longer distance walked during the 90-day 6-minute walk test (472 vs 376 m; P = .019).
• CAVT patients near normalized by 90-days were walking 94% of their predicted walk distance versus 75% of those in the anticoagulation only arm (P = .022).
• Safety rates were comparable through 90 days with no device-related mortality, no additional PE-related mortality > 7 days, and no difference in symptomatic PE recurrence. These findings confirmed the safety profile of CAVT, noted the company.

“These impressive functional outcomes combined with superior reduction in right heart strain add to the growing body of evidence demonstrating the significant impact CAVT can have on acute PE patients,” stated Dr. Lookstein, in the press release. “This is a foundational trial that will significantly advance PE care, allowing these advanced therapies to be offered to more patients, improving patient outcomes, and potentially leading to the inclusion in future treatment guidelines.”

Dr. Rosovsky added, “The latest STORM-PE findings demonstrate substantial improvements in both clinical and functional outcomes, with a significantly higher proportion of patients treated with CAVT plus anticoagulation returning to normalization within 48 hours compared to anticoagulation alone.

“STORM-PE highlights the critical importance of early intervention in patients with intermediate-high risk PE and provides the strongest evidence to date that advanced therapy with CAVT offers superior efficacy compared to the current standard treatment of anticoagulation alone. These breakthrough results not only advance the field but also have the potential to meaningfully improve patient care and recovery.”