European Regulators Approve Penumbra’s Computer-Assisted Vacuum Thrombectomy Tech

Penumbra Inc. has secured a CE Mark for its latest computer assisted vacuum thrombectomy (CAVT) technologies—Lightning Flash 2.0 and Lightning Bolt 7.  
 
“Based on outcomes from our clinical trials and from physicians using our devices globally, our CAVT technologies have greatly improved our ability to rapidly and safely remove clot in the vascular system,” Penumbra Chief Medical Officer James F. Benenati, M.D., said. “With quicker procedures and more efficient clot removal, we have improved outcomes while demonstrating a high level of safety. As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 and Lightning Bolt 7 will provide physicians in Europe with the confidence that CAVT is a valuable first line option to manage conditions such as PE, venous thrombosis, and acute limb ischemia.”   
 
Penumbra’s Lightning products will be the only CAVT systems available in Europe and each are designed to help physicians optimize patient care.   
 
Lightning Flash 2.0 is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus, according to the company. It features Penumbra’s Lightning Intelligent Aspiration technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash 2.0 catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. It is designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body’s complex anatomy and deliver high power aspiration for clot removal with minimal blood loss. Additionally, with streamlined audio-visual feedback, Lightning Flash 2.0 enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure. 
 
“We have utilized Penumbra’s aspiration technology since the introduction of the first-generation Indigo System, witnessing significant advancements with each new iteration,” said Prof. Nils Kucher, director of the Department of Angiology at the University Hospital Zurich, Switzerland. “Our team has experience with the 12F system for acute venous thrombosis, and with this latest advancement, we are hopeful that the procedures will be even more efficient for PE and venous thrombosis as we have received positive feedback from colleagues in the U.S.” 
 
“We are eagerly anticipating the opportunity to use the new Lightning Flash 2.0 System, as it promises aspiration capabilities to address large clot burden quickly and has the potential to minimize blood loss,” said Prof. Stefano Barco, Department of Angiology at the University Hospital Zurich, Switzerland. 
 
Lightning Bolt 7 is the most powerful arterial thrombectomy system on the market, Penumbra claims. Lightning Bolt 7 introduces a new method for removing blood clots—modulated aspiration—which pairs Penumbra’s Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm. When used together, Lightning Bolt 7 is designed to enhance the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss, addressing conditions such as acute limb ischemia (ALI), hibernating thrombus and visceral occlusions. Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow. Additionally, it is designed to break the friction between the catheter and clot by having the computer algorithms rapidly modulate aspiration to quickly fatigue the thrombus and remove the clot from the arteries. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots.  
 
“In my opinion, computer assisted thrombus removal is the future of arterial clot management and offers the promise of peak procedural efficiency that was not previously available to endovascular specialists,” said Dr. Gianmarco de Donato, chief of the Vascular Surgery Unit, University Hospital of Siena, Italy. “Our ability to rapidly revascularize vessels with minimal blood loss is crucial for achieving optimal patient outcomes.” 
 
The European approval of Lightning Flash 2.0 and Lightning Bolt 7 follows CE Mark authorization for five of Penumbra’s stroke reperfusion and access catheters. 
 
Penumbra Inc. develops technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Its portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. The company supports healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life.