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Penumbra’s Lightning Flash 2.0 thrombectomy system gets FDA nod

Penumbra, Inc. announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™ 2.0, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new advancements combined with Penumbra’s novel catheter technology allow physicians to better navigate the body’s complex anatomy and deliver high power for clot removal with possible minimal blood loss.

“Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. 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,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.”

With streamlined audio-visual feedback, Lightning Flash 2.0 enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure. This enhanced feedback loop results in a more intuitive thrombus removal experience for the physician.

“Lightning Flash 2.0 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety,” said Adam Elsesser, president and chief executive officer of Penumbra. “Our ongoing innovation around CAVT underscores our commitment to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced therapy.”

Lightning Flash 2.0 is part of Penumbra’s Indigo® System with Lightning® portfolio. The company’s Lightning products are the only computer assisted mechanical thrombectomy systems currently available in the U.S. and early clinical data has demonstrated improvement in patient clinical outcomes and quality of life.
MB Bureau

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