Penumbra Lightning Flash 2.0 CAVT System Cleared by FDA and Launched

April 23, 2024—Penumbra, Inc. announced the FDA clearance and launch of Lightning Flash 2.0, the company’s next-generation computer assisted vacuum thrombectomy (CAVT) system for removal of venous thrombus and treatment of pulmonary emboli.

Lightning Flash 2.0 is part of Penumbra’s Indigo System with Lightning portfolio.

According to the company, the new system features advanced Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. These are combined with Penumbra’s catheter technology to allow physicians to better navigate the body’s complex anatomy and deliver high power for clot removal while minimizing blood loss.

Additionally, Lightning Flash 2.0’s streamlined audio-visual feedback enables physicians to better understand what is occurring at the tip of the catheter during a procedure, resulting in a more intuitive thrombus removal experience for the physician.

James F. Benenati, MD, Chief Medical Officer at Penumbra, discussed the latest product in the company’s press release.

“Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time,” commented Dr. Benenati. “It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients. As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.”