Penumbra, Inc. engages in the design, development, manufacture, and marketing of innovative medical devices. It offers neurovascular thrombectomy and embolization and access technologies, neurosurgical tools, Penumbra LANTERN Delivery Microcatheter, and Penumbra Occlusion Device (POD) system. The company was founded by Arani Bose and Adam Elsesser on June 21, 2004, and is headquartered in Alameda, CA.
Clinical Trials
34
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
2.9%
Completed
23
67.7%
Recruiting
4
11.8%
Terminated
3
8.8%
Withdrawn
3
8.8%
No approval data available
- Boston Scientific announced its agreement to acquire medical equipment maker Penumbra for $14.5 billion to expand its vascular pipeline capabilities. - The acquisition will be financed through a combination of cash on hand and new debt, with $11 billion allocated for the cash portion of the transaction. - Boston Scientific projects the deal will be slightly dilutive to adjusted earnings per share in the first year but expects it to become neutral to slightly accretive in the second year. - The company forecasts fiscal year 2025 revenue of approximately $1.4 billion following the acquisition completion.
- The STORM-PE randomized controlled trial demonstrated that computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation significantly reduced right heart strain compared to anticoagulation alone in intermediate-high risk pulmonary embolism patients. - Patients receiving CAVT showed 2.7 times greater thrombus burden reduction, improved physiological recovery with lower heart rates, and 2.2 times greater likelihood of functional status recovery. - The trial enrolled 100 patients across 22 international sites and represents the first randomized study comparing mechanical thrombectomy to standard anticoagulation therapy for pulmonary embolism. - Safety profiles were comparable between treatment groups, with no device-related mortality and similar rates of major adverse events through 90 days.
- Penumbra has completed enrollment of 100 patients in the pivotal STORM-PE randomized controlled trial, comparing computer assisted vacuum thrombectomy plus anticoagulation versus anticoagulation alone for acute intermediate-high risk pulmonary embolism. - The first-of-its-kind trial aims to provide level 1 clinical evidence on whether endovascular therapy with CAVT is superior to medical therapy alone for this critically ill patient population. - Pulmonary embolism affects an estimated 900,000 Americans annually and can be life-threatening, with 10-30 percent of individuals dying within one month of diagnosis. - The trial results will inform treatment guidelines for intermediate-high risk PE patients, where current treatment strategies are not well defined despite the condition being a leading cause of cardiovascular morbidity and mortality.
- Penumbra received FDA clearance for the Ruby XL System, featuring the longest, largest, and softest embolization coils commercially available for vascular procedures. - The system introduces three unique coil technologies designed to deliver more volume per coil than existing products, potentially reducing radiation exposure and improving procedural efficiency. - Ruby XL coils offer extended lengths up to 70 cm and sizes up to 40mm, specifically engineered for large vessel and high-flow embolization applications.
- Penumbra, Inc. has completed enrollment in its THUNDER clinical study, evaluating the Penumbra System with Thunderbolt Aspiration Tubing for acute ischemic stroke. - The THUNDER study assesses the safety and efficacy of Penumbra's computer-assisted vacuum thrombectomy (CAVT) technology for removing blood clots in the brain. - The multi-center, single-arm study focuses on patients with large vessel occlusion eligible for mechanical thrombectomy, with revascularization as the primary endpoint. - Penumbra's Thunderbolt technology utilizes a software algorithm to modulate aspiration, potentially enabling more rapid and complete clot removal during stroke treatment.
