Daily Newsletter

24 April 2024

Daily Newsletter

24 April 2024

Penumbra secures FDA clearance for Lightning Flash 2.0 thrombectomy system

This next-generation computer-assisted vacuum thrombectomy system can remove venous thrombus and in treating pulmonary emboli.

Surya Akella April 24 2024

US-based thrombectomy company Penumbra has secured FDA clearance and launched its Lightning Flash 2.0, a next-generation computer-assisted vacuum thrombectomy (CAVT) system.

The Lightning Flash 2.0 system has been designed to remove venous thrombus and treat pulmonary emboli (PE).

It features advanced algorithms for increased speed and sensitivity during clot removal.

This advancement, coupled with Penumbra's new catheter technology, will facilitate physicians in navigating the body's complex anatomy and delivering high power for effective clot removal, potentially minimising blood loss.

The system offers streamlined audio-visual feedback providing physicians with a clearer understanding of the catheter's position during procedures, leading to a more intuitive thrombus removal experience.

Penumbra chief medical officer James F 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 key component of Penumbra's Indigo System with Lightning portfolio.

It is claimed to be the only computer-assisted mechanical thrombectomy system available in the US market.

Early clinical data has shown that the use of Lightning Flash 2.0 can lead to improvements in patient clinical outcomes and quality of life.

Last June, the company introduced the Lightning Bolt 7 arterial thrombectomy system.

Lightning Bolt 7 introduced a new method called modulated aspiration to remove blood clots, which combined the company’s Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm.

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