Penumbra
Penumbra Lightning Bolt 7
Penumbra, Inc has announced it has secured CE Mark in Europe for its latest computer assisted vacuum thrombectomy (CAVT) technologies, Lightning Flash 2.0 and Lightning Bolt 7. Penumbra says its Lightning products will be the only CAVT systems available in Europe and each are designed to help physicians optimise patient care.
James F. Benenati, M.D., FSIR, Chief Medical Officer at Penumbra said: “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. 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 says that Lightning Flash 2.0 is the 'most advanced' mechanical thrombectomy system on the market to address venous and pulmonary thrombus. 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 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 according to the company.
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“We have utilised 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 minimise blood loss,” said Prof. Stefano Barco, Department of Angiology at the University Hospital Zurich, Switzerland.
According to Penumbra, Lightning Bolt 7 is the 'most powerful' arterial thrombectomy system on the market. Lightning Bolt 7 introduces a new method for removing blood clots called 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, as well as being 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 Vascular Surgery Unit, University Hospital of Siena, Italy. “Our ability to rapidly revascularise vessels with minimal blood loss is crucial for achieving optimal patient outcomes.”
