Penumbra today announced it has secured CE mark in Europe for two 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,” said James F Benenati, chief medical officer at Penumbra. “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 pulmonary embolism (PE), venous thrombosis, and acute limb ischaemia (ALI).”
A press release details that Penumbra’s Lightning products will be the only CAVT systems available in Europe.
Lightning Flash 2.0
According to Penumbra, 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, Penumbra notes, allowing physicians to better navigate the body’s complex anatomy and deliver high power aspiration for clot removal with minimal blood loss.
Additionally, Lightning Flash 2.0 has streamlined audio-visual feedback, which Penumbra states enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure.
“We have utilised Penumbra’s aspiration technology since the introduction of the first-generation Indigo system, witnessing significant advancements with each new iteration,” said Nils Kucher, director of the Department of Angiology at University Hospital Zurich (Zurich, Switzerland).
“Our team has experience with the 12Fr 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 USA.”
“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 Stefano Barco, Department of Angiology at University Hospital Zurich.
Lightning Bolt 7
Penumbra claims that Lightning Bolt 7 is the most powerful arterial thrombectomy system on the market. 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 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 Gianmarco de Donato, chief of the Vascular Surgery Unit at University Hospital of Siena (Siena, Italy). “Our ability to rapidly revascularise vessels with minimal blood loss is crucial for achieving optimal patient outcomes.”
Lightning Flash 2.0 and Lightning Bolt 7 come on the heels of Penumbra recently receiving CE mark for five of its stroke reperfusion and access catheters, expanding both its neuro and vascular portfolios in Europe.
