Friday, June 02, 2023
Penumbra, Inc., a globally recognized healthcare company specializing in innovative therapies (NYSE: PEN), has recently unveiled Lightning Bolt™ 7, the most advanced and powerful arterial thrombectomy system available on the market. This groundbreaking system has received clearance from the U.S. Food and Drug Administration (FDA) and is now ready for launch. Lightning Bolt 7 introduces a pioneering approach to removing blood clots, known as modulated aspiration. By combining Penumbra's Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm, this system enhances the ability to swiftly eliminate large, fibrous blood clots in the arteries, all while minimizing blood loss. Its capabilities make it particularly effective in addressing conditions such as acute limb ischemia (ALI), hibernating thrombus, and visceral occlusions. Penumbra's Lightning Bolt 7 marks a significant advancement in the field of arterial thrombectomy, providing a cutting-edge solution for these critical medical scenarios.
"The unique mechanism of Lightning Bolt 7 enables modulated aspiration at the catheter tip, allowing for the quick removal of rigid and stiff blood clots that often necessitate open surgery and can result in amputation",said Dr. Kalyan Veerina, an interventional cardiologist at the Cardiovascular Institute of the South (CIS)."Lightning Bolt 7 represents a critical frontline option for physicians to improve patient outcomes".
Lightning Bolt 7, powered by the Penumbra ENGINE®, is designed to differentiate between blood clot and blood flow. It also detects friction within the catheter, orchestrating the rapid opening and closing of valves to disrupt any resistance between the clot and the catheter tip. This maximizes the vacuum force at the catheter tip, facilitating the optimal and rapid ingestion of blood clots. Lightning Bolt 7 is compatible with Penumbra's arterial catheters, which utilize MaxID hypotube technology. These catheters have a larger inner diameter, a lower profile, and a soft, atraumatic tip design, enhancing the sweeping capability within the artery.
According to Dr. Sahil A. Parikh, Director of Endovascular Services at Columbia University Irving Medical Center,"This era of computer-aided technology offers unprecedented procedural efficiency for endovascular specialists. These intelligent devices allow us to rapidly restore blood flow with minimal blood loss."
Dr. Raghu Motaganahalli, a vascular surgeon with Indiana University Health Physicians, stated, "Technologically, Lightning Bolt 7 is a significant advancement. The integration of computer-aided components provides a safety profile that, combined with the speed and efficiency of clot removal, promotes 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 is currently the only computer-aided mechanical thrombectomy system available in the U.S. Previous data from the Indigo System has demonstrated excellent 30-day limb salvage rates in over 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 Dr. James F. Benenati, Chief Medical Officer at Penumbra." Lightning Flash and Lightning Bolt 7 will continue to advance the standard of care for these challenging conditions, removing clots from the body quickly, safely, and in a single session, without the need for lytics or open surgery, potentially improving the quality of life for our patients".