Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning BoltTM 7, the most advanced and 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 acute limb ischemia (ALI), hibernating thrombus and visceral occlusions.
“The unique mechanism of Lightning Bolt 7 provides modulated aspiration at the tip of the catheter, enabling the quick removal of these rigid and stiff blood clots, which oftentimes require open surgery and frequently result in amputation,” said Kalyan Veerina, M.D., interventional cardiologist at Cardiovascular Institute of the South (CIS). “Advancements like Lightning Bolt 7 provide a critical frontline option for physicians to treat patients and improve patient outcomes.”
Powered by the Penumbra ENGINE®, Lightning Bolt 7 is engineered to detect the difference between blood clot and blood flow. Additionally, it is designed to identify friction within the catheter and orchestrate the rapid opening and closing of the valves to disrupt any resistance between the clot and the catheter tip. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots. Lightning Bolt 7 is compatible with Penumbra’s arterial catheters, which are made with MaxID hypotube technology, allowing a larger inner diameter while maintaining a lower profile and a soft, atraumatic tip design to maximize the circumferential sweep in the artery.
“This era of computer-aided technology offers the promise of unheralded procedural efficiency that was not previously available to endovascular specialists,” said Sahil A. Parikh, M.D., Director of Endovascular Services at Columbia University Irving Medical Center. “Our ability to rapidly revascularize vessels with minimal blood loss is exceptional with these intelligent devices.”
“Technologically, Lightning Bolt 7 is a big leap forward,” said Raghu Motaganahalli, MD, FRCS, FACS, DFSVS, vascular surgeon with Indiana University Health Physicians. “The computer-aided components offer a safety profile that, when combined with the clot removal speed and efficiency, will promote an endovascular-first approach for a broader range of cases before considering open surgery.”
Lightning Bolt 7 received FDA clearance and became available in March 2023. It is part of Penumbra’s Indigo® System with Lightning portfolio, which are the only computer-aided mechanical thrombectomy systems currently available in the U.S. Prior to the availability of Lightning Bolt 7, data with the Indigo System have shown excellent 30-day limb salvage rates in more than 98% of patients, short procedure times with an average of 22 minutes and low 30-day mortality at 3%.
“With our latest advancements in computer-aided technologies, Penumbra offers one of the most comprehensive mechanical thrombectomy product lines for arterial, venous, pulmonary and mesenteric thrombus,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “Lightning Flash and Lightning Bolt 7 will continue to advance the standard of care for these difficult conditions, removing clot from the body quickly, safely, in a single session, and without the need for lytics or open surgery, potentially improving quality of life for our patients.”