Penumbra, Inc., a leading thrombectomy company, has announced the completion of enrollment in its THUNDER (Thrombectomy under Navigation with Distal Access for Rapid Embolus evacuation) clinical study. The study is designed to evaluate the safety and efficacy of the Penumbra System with Thunderbolt Aspiration Tubing in patients experiencing acute ischemic stroke due to intracranial large vessel occlusion (LVO).
The THUNDER study (NCT05437055) is a prospective, multi-center, single-arm trial. It aims to assess the effectiveness of Penumbra's latest computer-assisted vacuum thrombectomy (CAVT) technology in achieving rapid and complete removal of blood clots from the brain. Patients eligible for mechanical thrombectomy due to acute ischemic stroke secondary to intracranial LVO are included in the study.
Technology and Mechanism
The Penumbra System with Thunderbolt Aspiration Tubing incorporates an advanced CAVT software algorithm. This algorithm generates proprietary modulated aspiration, which reduces friction between the clot and the reperfusion catheter. The intended outcome is a more rapid and complete removal of blood clots, potentially improving patient outcomes in acute stroke cases. The Thunderbolt Aspiration Tubing is designed for use with the Penumbra ENGINE™ and RED™ reperfusion catheters.
Clinical Significance
Adam Elsesser, president and chief executive officer of Penumbra, stated, "This critical milestone brings us another step closer to providing physicians with the latest technology for stroke management. The THUNDER study will provide the data set needed to evaluate Penumbra’s Thunderbolt technology, and I am optimistic that we are at the dawn of a new era in stroke treatment."
The primary efficacy endpoint of the THUNDER study is the revascularization of the occluded target vessel immediately post-procedure. The study will provide crucial data on the device's ability to restore blood flow in the brain, a critical factor in reducing the long-term effects of stroke.
Penumbra's focus is on developing innovative technologies for challenging medical conditions, including ischemic stroke and venous thromboembolism. Their computer-assisted vacuum thrombectomy (CAVT) approach aims to remove blood clots from head-to-toe with speed, safety, and simplicity. Penumbra supports healthcare providers in over 100 countries, striving to improve patient outcomes and quality of life.
