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Home » FDA clears computer-assisted thrombectomy system from Penumbra

FDA clears computer-assisted thrombectomy system from Penumbra

April 23, 2024 By Sean Whooley

Penumbra Lightning Flash 2 computer-assisted thrombectomy system
The Lightning Flash 2.0 computer-assisted thrombectomy system. [Image courtesy of Penumbra]
Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system.

Lightning Flash 2.0 represents the next generation of the company’s computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE).

The system features Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. Combined with Penumbra’s novel catheter technology, the new advancements help to better navigate the patient’s anatomy. This helps to deliver high power for clot removal with possible minimal blood loss.

Dr. James F. Benenati, chief medical officer at Penumbra said the company already has positive feedback from its initial launch. Early reports showed improved procedure time through shortened aspiration time, plus 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,” Benenati said.

Alameda, California-based Penumbra also added streamlined audio-visual feedback. This offers a better understanding of what happens at the tip of the catheter during a procedure for physicians. The enhanced feedback loop enables more intuitive thrombus removal 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 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.”

Filed Under: 510(k), Business/Financial News, Catheters, Featured, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Vascular Tagged With: Penumbra, Penumbra Inc.

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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