US-based medical device company Penumbra has announced the US Food and Drug Administration (FDA) approval and commercialisation of Lightning Flash 2.0.

Lightning Flash 2.0 is the next-generation computer-assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE).

The next-gen CAVT system features advanced Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow.

Together with Penumbra’s novel catheter technology, the system will help physicians better navigate through complex anatomy and deliver superior clot removal with minimal blood loss.

Penumbra FSIR chief medical officer James Benenati said: “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.

“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 is a part of Penumbra’s Indigo System within the Lightning portfolio.

The system enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure, with streamlined audio-visual feedback.

Its enhanced feedback loop will enable an enhanced intuitive thrombus removal experience for the physician.

Penumbra said that its Lightning family of products are the only computer-assisted mechanical thrombectomy systems currently available in the US.

Penumbra president and CEO Adam Elsesser said: “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.

“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.”