Thrombectomy technology leader, Penumbra Inc. has secured CE Mark in Europe for the latest computer assisted vacuum thrombectomy (CAVT) devices.
Background
Penumbra is a frequent visitor to our pages. The company’s newly CE marked devices are designed to remove blood clots “from head-to-toe” with speed, safety and simplicity. The regulatory clearances make Lightning Flash™ 2.0 and Lightning Bolt™ 7 the only CAVT systems available in Europe.
Penumbra recently receiving CE Mark for five of its stroke reperfusion and access catheters. The company is expanding both its neuro and vascular portfolios in Europe. Now the addition of Lightning Flash™ 2.0 and Lightning Bolt™ 7 means physicians have a robust selection of devices to remove blood clots throughout the body.
Thrombectomy System Advances from Penumbra
Lightning Flash 2.0
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. The algorithm uses both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash 2.0 catheter features MaxID hypotube technology. This allows for an inner diameter similar to large-bore catheters while maintaining a lower profile. It also features a soft, atraumatic tip design. Its design enables clinicians to remove blood clots with speed, safety and simplicity. In so doing it allows 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 provides streamlined audio-visual feedback. This enables physicians to have a better understanding of what is occurring at the tip of the catheter.
Lightning Bolt 7
Lightning Bolt 7 is the most powerful arterial thrombectomy system on the market. The system introduces a new method for removing blood clots, termed modulated aspiration. This pairs Penumbra’s Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm. As such Lightning Bolt 7 enhances the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss. In so doing it addresses 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.
Company comments
Penumbra’s Chief Medical Officer, James F. Benenati, M.D., FSIR comments about the technologies. “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.”
Clinician comments
“We have utilized Penumbra’s aspiration technology since the introduction of the first-generation Indigo System, witnessing significant advancements with each new iteration.” So 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.
“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 revascularize vessels with minimal blood loss is crucial for achieving optimal patient outcomes.”
Source: www.penumbrainc.com
published: September 19, 2024 in: Approval/Clearance, Technology, Vascular
