Penumbra’s Next-Gen Computer-Assisted Vacuum Thrombectomy Wins FDA Nod

Penumbra obtained U.S. Food and Drug Administration (FDA) clearance for and launched Lightning Flash 2.0, its next-generation, computer-assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE).
 
Lightning Flash 2.0 has advanced algorithms to increase speed and sensitivity to thrombus and blood flow, according to the company. Combined with its catheter tech, the company expects the new advancements to help physicians better navigate complex anatomy, as well as deliver high power for clot removal with minimal blood loss.
 
The CAVT system has streamlined audio-visual feedback to provide better understand of what is happening at the catheter’s tip during. The procedure. The enhanced feedback loop, the company said, creates a more intuitive thombus removal experience for the physician.
 
“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, MD, 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.”
 
“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,” added Adam Elsesser, president and CEO 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.”