Next-generation clot removal system for pulmonary embolism cleared by FDA, launched
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Key takeaways:
- An FDA-cleared computer-assisted vacuum thrombectomy system was launched.
- The next-generation system is designed to improve removal of venous thrombus and treat pulmonary emboli.
Penumbra announced the FDA clearance and launch of its next-generation computer-assisted vacuum thrombectomy system to remove venous thrombus and treat pulmonary emboli.
The thrombectomy system (Lightning Flash 2.0) features advanced algorithms for increased sensitivity, that when combined with the company's novel catheter technology, is designed to improve navigation of complex anatomy and deliver high-power clot removal, possibly with minimal blood loss, according to a press release from the company.
The system also features an enhanced feedback loop designed to improve the thrombus removal experience for the physician, according to the 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. 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," James F. Benenati, MD, FSIR, chief medical officer at Penumbra, said in the release. "As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that [computer-assisted vacuum thrombectomy] is a valuable frontline option."
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