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Home » FDA clears Lightning Flash thrombectomy system from Penumbra

FDA clears Lightning Flash thrombectomy system from Penumbra

January 10, 2023 By Sean Whooley

Penumbra Lightning Flash mechanical thrombectomy system
[Image courtesy of Penumbra]
Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system.

Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash “the most advanced and powerful mechanical thrombectomy system on the market.”

Lightning Flash features the company’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove large blood clots. This includes venous thrombus and pulmonary emboli (PE).

“Penumbra’s Lightning Flash gives physicians a highly torqueable, larger catheter that is designed to remove a large clot burden in the pulmonary arteries or deep venous system more efficiently while maintaining an excellent safety profile because of Lightning’s computer-aided algorithms,” said Dr. James F. Benenati, CMO at Penumbra. “We believe that patients can have improved outcomes with this new technology because of the exceptional trackability and unique ability to distinguish flowing blood from clot.”

More on the Penumbra Lightning Flash design

Penumbra’s Engine powers the Lightning Flash to use both pressure and flow-based algorithms. These detect blood clot and blood flow.

The company made the system’s catheter with MaxID hypotube technology. This technology allows for an inner diameter similar to large-bore catheters. However, it maintains a lower profile with a soft, atraumatic tip for navigating the anatomy of the body.

When all combined together, the device helps remove blood clots while minimizing potential blood loss, Penumbra said.

The computer-aided system comprises part of the Penumbra Indigo system within the Lightning portfolio. Penumbra President of Interventional, Sandra Lesenfants, noted that these innovations have a “significant impact” on patients. She said they “will continue to transform the standard of care for these difficult conditions.”

“Lightning Flash will fundamentally change how blood clots are removed from the body,” said Adam Elsesser, president and CEO of Penumbra. “With this latest advancement, physicians are more likely to adopt mechanical thrombectomy because a broad spectrum of blood clots can be removed much quicker and less invasively than current interventional or surgical methods. This means that we are able to help even more patients with our technology, which is core to who we are as a company.”

Filed Under: Business/Financial News, Catheters, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: FDA, Penumbra

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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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