Penumbra, Inc.

Penumbra's CAVT Technology Receives FDA Clearance for the Treatment of Deep Vein Thrombosis (DVT)

Penumbra received FDA clearance for its Lightning CAVT technology to treat deep vein thrombosis — the first cleared DVT indication among mechanical thrombectomy devices. The clearance is supported by the BOLT-DVT IDE trial, which showed 98% complete or near-complete clot removal, an 18-minute median device time, a 3.1% 48-hour major adverse event rate, and a 3.9% 30-day re-thrombosis rate. The indication opens an estimated 900,000 annual U.S. venous thromboembolism cases to advanced intervention, expanding Penumbra's addressable market; the company remains subject to a pending acquisition by Boston Scientific.

•5d ago

New STORM-PE Data Demonstrate Correlation Between Clinical Assessments and Real-world Functional Recovery Captured Through Wearable Technology in Patients with Pulmonary Embolism

Penumbra announced STORM-PE subset data showing the first significant correlation between wearable-derived daily step activity and the 6-minute walk test in pulmonary embolism patients, presented at the VIVA meeting. CAVT plus anticoagulation showed improved right ventricular recovery and greater functional improvement versus anticoagulation alone, and a new 1,000-patient STRIKE-PE interim analysis continued to support CAVT safety and one-year quality-of-life benefits. The findings strengthen the clinical evidence base for Penumbra's Lightning Flash CAVT portfolio, but the stock's dominant catalyst remains the pending acquisition by Boston Scientific Corporation.

•19d ago

Penumbra, Inc. Reports Second Quarter 2026 Financial Results

Acquisition target Penumbra reported second-quarter revenue of $390.0 million, up 14.9% year-over-year, with gross profit margin expanding 190 basis points to 67.9%. Global thrombectomy revenue increased 12.5% to $259.0 million, while embolization and access revenue grew 20.0% to $131.1 million. Due to the pending acquisition by Boston Scientific, Penumbra did not provide full-year financial guidance and will not host a conference call.

•2mo ago

THUNDER Study Demonstrates Penumbra's THUNDERBOLT is Safe and Effective for Stroke Care

Penumbra announced positive results from the THUNDER IDE study for its THUNDERBOLT system, showing 87.5% successful reperfusion in stroke patients with large vessel occlusion. The data demonstrated a high rate of complete clot ingestion at 83% and a median procedure time of 20 minutes, with a low 2.8% rate of serious adverse events. THUNDERBOLT recently received FDA clearance and CE Mark; these findings support the clinical efficacy of the company's computer assisted vacuum thrombectomy technology.

•3mo ago

First Patient Enrolled in Penumbra's FORWARD Study Evaluating Mechanical Thrombectomy and Computer Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke

Penumbra initiated the FORWARD study, enrolling the first patient to evaluate mechanical thrombectomy and Computer Assisted Vacuum Thrombectomy (CAVT) for distal acute ischemic stroke. The real-world, multi-center study plans to enroll up to 250 participants across approximately 40 sites, focusing on Penumbra's RED reperfusion catheter portfolio and THUNDERBOLT platform for M2 occlusions. This research aims to address distal vessel occlusions, which account for roughly 25-40% of acute ischemic strokes, by determining if thrombectomy benefits can extend to this complex patient population.

•3mo ago

Penumbra Expands CAVT for Stroke to Europe with CE Mark for THUNDERBOLT

Penumbra secured CE Mark approval for its THUNDERBOLT device, enabling the launch of its Computer Assisted Vacuum Thrombectomy (CAVT) technology in Europe. THUNDERBOLT is the only CAVT device available for stroke treatment in both Europe and the US, introducing modulated aspiration to improve clot removal speed and completeness. The release notes a pending acquisition by Boston Scientific, which introduces regulatory and operational uncertainty regarding the future independence of the PEN ticker.

•4mo ago

Penumbra's THUNDERBOLT Receives FDA Clearance - Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

Penumbra received FDA clearance for THUNDERBOLT, the first Computer Assisted Vacuum Thrombectomy (CAVT) platform designed to address acute ischemic stroke by enabling faster, more complete clot removal. The technology leverages the Penumbra ENGINE to deliver modulated aspiration, a mechanism intended to minimize catheter manipulation and safely ingest clot at the site of occlusion. THUNDERBOLT will be pre-packaged with Penumbra's existing RED family of catheters, including the RED 72 SILVER LABEL with SENDit technology, expanding the company's offerings in stroke care.

•4mo ago