Penumbra, Inc. · NYSE:PEN
Penumbra — VIVA 2025
21 slides from Penumbra's conference presentation, November 2025
Slide 1: Randomized Controlled Trial of Mechanical Thrombectomy vs Anticoagulation Alone for Intermediate-High Risk PE
Randomized Controlled Trial of Mechanical Thrombectomy with Anticoagulation versus Anticoagulation Alone for Acute Intermediate-High Risk PE: Primary Outcome, Functional Endpoints, and Core Lab Findings from STORM-PE Rachel P. Rosovsky, MD, MPH Massachusetts General Hospital and Harvard Medical Scho
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships • Institutional research support: BMS, Janssen, and Penumbra • Consultant: Boston Scientific, Dova, Inari, Inquis, Janssen, Penumbra, and Thrombolex • Immediate Past-President of The PERT Consortium® Speaker Name (VIVA staff will add during review)
Slide 3: Background
Background Pulmonary Embolism (PE) Prevalence Pe •1 in 1,000 adults globally per year STORM-PE: •Considerable socioeconomic burden •Reduced functionality and quality of life First ever RCT to evaluate MT (CAVT) Intermediate-High Risk PE + AC vs AC alone •Elevated RV/LV ratio & cardiac biomarkers Spo
Slide 4: Key Eligibility Criteria & Trial Design
Key Eligibility Criteria & Trial Design 100 Acute Intermediate- Inclusion high Risk Patients Clinical signs & symptoms of acute PE (≤ 14 days) CAVT + AC AC Alone CTPA showing filling defect in ≥ 1 main or 47 Patients 53 Patients proximal lobar pulmonary artery RV/LV ratio ≥ 1.0 on CTPA Elev
Slide 5: Visit Schedule & Data Collection
Visit Schedule & Data Collection Standardized treatment: initiated within 24 hours from baseline CTPA and ≤ 12 hours from randomization Baseline Day 0 48 Hours Discharge 30 Days 90 Days Randomization Primary Endpoint Safety Endpoint Final Visit NEWS2 NEWS2 NEWS2 QoL QoL CTPA CTPA MAE
Slide 6: Baseline & Medical History Information
Baseline & Medical History Information Both groups were well matched across key baseline measures CAVT AC CAVT AC N=47 N=53 N=47 N=53 Demographic characteristics Index PE presentation data Age (years) 59.5 ± 13.2 61.2 ± 14.2 Syncope 9 (19.1%) 8 (15.1%) Female Sex 18 (38.3%) 28 (52.8%) Elevated cardi
Slide 7: CAVT Arm Procedural Information and Details
CAVT Arm Procedural Information and Details Thrombectomy Time, min 25.0 [15.0, 41.0] Procedure Time, min 56.0 [42.0, 69.0] Estimated Blood Loss, mL 296.5 ± 179.4 Technical Success 47/47 (100%) Ability of catheter to access clot and perform aspiration Device- or Procedure-related Transfusion 0/47 (0%
Slide 8: Primary Efficacy Endpoint: RV/LV Ratio
Primary Efficacy Endpoint: RV/LV Ratio P < 0.001 Superior reduction in the CAVT arm 29.7% vs 13.1% relative reduction relative reduction RV/LV Ratio CAVT AC P value 2.00 1.63 1.56 1.50 1.32 Baseline 1.63 ± 0.36 1.56 ± 0.35 0.397 1.11 1.00 48 hours 1.11 ± 0.28 1.32 ± 0.31 < 0.001 0.50 Absolute 0.00 0
Slide 9: Secondary Safety Endpoints
Secondary Safety Endpoints Through 90 Days Safety comparable in CAVT and AC arm 1.0 CAVT AC P value (N=47) (N=53) Freedom from Mortality 0.8 All-cause mortality P = 0.133 Composite MAE ≤ 7 Days 2 (4.3%) 4 (7.5%) 0.681 PE-related mortality P = 0.131 Clinical Deterioration Requiring 0.6 1 (2.1%) 3 (5.
Slide 10: Change in Thrombus Burden at 48 Hours
Change in Thrombus Burden at 48 Hours Significantly larger reduction in mean RMMS* in the CAVT arm (2.7x) Degree of thrombus burden Baseline 48 Hours 2.0 1.5 1.0 0.5 0.0 MORE LESS CAVT 42.1% relative mean reduction P < 0.001 15.6% AC relative mean reduction Paired data represented CAVT N=45 and AC N
Slide 11: Heart Rate and Tachycardia at Randomization and 48 Hours
Heart Rate and Tachycardia at Randomization and 48 Hours Mean Heart Rate (HR), bpm Tachycardia HR > 100, % of Patients 100 50% 95 91.1 40% 90 86.4 30% 23.9% 20.0% 85 88.5 20% P = 0.022 20.0% P = 0.008 80 10% 2.2% 80.0 75 0% Randomization* 48 Hours Randomization* 48 Hours CAVT (N=46) AC (N=50) CAVT (
Slide 12: Oxygen Requirement at Baseline and 48 Hours
Oxygen Requirement at Baseline and 48 Hours Mean Supplemental Oxygen*, L/min 5.0 48 h P = 0.027 4.0 3.3 Significantly lower 3.0 supplemental oxygen 3.0 requirement in the 2.0 CAVT arm at 48 hours 1.4 1.0 0.5 0.0 Baseline 48 hours Baseline 48 hours CAVT (N=44) AC (N=52) Paired data represented *Patie
Slide 13: NEWS2 at Baseline and 48 Hours
NEWS2 at Baseline and 48 Hours Composite score indicating risk of clinical deterioration 48 h P = 0.034 5 NEWS2 Components: Higher Risk 4.1 Respiratory rate 4 3.5 Supplemental oxygen 3 2.7 Oxygen requirement 2 1.8 Systolic blood pressure Heart rate Lower Risk 1 Consciousness 0 Temperat
Slide 14: Functional Endpoint: Borg & mMRC Dyspnea Scales
Functional Endpoint: Borg & mMRC Dyspnea Scales Mean Borg Dyspnea Score mMRC ≥ 1*, % of Patients P = 0.058 P = 0.109 95.5% 96.2% Maximal 10 100% 8 73.6% 75% 6 54.5% Severe 4.7 4.5 50% 4 2 1.0 1.5 25% None 0 0% Baseline Discharge Baseline Discharge Baseline Discharge Baseline Discharge CAVT (N=44) AC
Slide 15: Functional Endpoint: PVFS Scale
Functional Endpoint: PVFS Scale Functional Limitation Ordinal Scale Focusing on Aspects of Daily Life P value OR 2.2 Pre-PE Event to Discharge 0.032 CAVT patients were 2.2x more likely to move toward their pre-PE functional OR 2.0 status Baseline to Discharge 0.067 (significantly less change in PVFS
Slide 16: Functional Endpoint: 6 Minute Walk Test (6MWT)
Functional Endpoint: 6 Minute Walk Test (6MWT) Mean 6MWT Distance (6MWD), meters Mean ∆ 6MWD Between 30 & 90 Days 500 472 450 CAVT ∆ 85 P = 0.019 400 387 376 P = 0.099 350 328 AC ∆ 48 300 30 days 90 days 0 20 40 60 80 100 CAVT (N=27) AC (N=29) Distance, meters CAVT patients walked significantly fart
Slide 17: Functional Endpoint: % of Predicted 6MWD at 90 Days
Functional Endpoint: % of Predicted 6MWD at 90 Days Predicted walk distance1 is normalized for sex, age, and body surface area P = 0.022 100% 94.0% 80% 75.2% CAVT patients were able to 60% complete significantly more of their predicted walk distance 40% 20% 0% CAVT AC N=31 N=34 Paired data represent
Slide 18: Conclusion
Conclusion STORM-PE is the first RCT to report the results of mechanical thrombectomy with AC versus AC alone. The CAVT arm demonstrated superior reduction in RV dilatation and a similar safety profile to the AC arm. Treatment with CAVT resulted in early physiological recovery and greater reduction
Slide 19: Primary Outcomes From the STORM-PE Trial (Circulation 2025)
Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial Robert A. Lookstein, MD, MS, FSIR, FAHA, FSVM; Stavros V. Konstantinides, MD, FESC; Ido Weinberg, MD;
Slide 20: Thank You
Thank You In partnership with The PERT Consortium® Sites Ascension Seton Kingwood Hospital Rush University Medical Center Austin, TX, USA Kingwood, TX, USA Chicago, IL, USA Auckland City Hospital Krakowski Szpital Specjalistyczny św. Jana Pawła II Sentara Norfolk General Hospital Grafton, Auckland,
Slide 21: STORM-PE RCT Steering Committee
STORM-PE RCT Steering Committee Dr. Rachel Rosovsky Dr. Robert Lookstein Dr. Richard Channick Hematology Interventional Radiology Pulmonology Massachusetts General Mount Sinai UCLA Hospital Dr. Stavros Konstantinides Dr. John Moriarty Dr. Ido Weinberg Cardiology Interventional Radiology Vascular Med