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FDA clears Lightning Flash thrombectomy system from Penumbra

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[Image courtesy of Penumbra]

Penumbra (NYSE:PEN) introduced right now that it obtained FDA clearance for the Lightning Flash mechanical thrombectomy system.

Alameda, California-based Penumbra additionally initiated the launch for the system. The corporate known as Lightning Flash “probably the most superior and highly effective mechanical thrombectomy system in the marketplace.”

Lightning Flash options the corporate’s novel Lightning clever aspiration expertise with dual-clot detection algorithms. Combining it with progressive catheter engineering, Penumbra designed Lightning Flash to shortly take away giant blood clots. This contains venous thrombus and pulmonary emboli (PE).

“Penumbra’s Lightning Flash offers physicians a extremely torqueable, bigger catheter that’s designed to take away a big clot burden within the pulmonary arteries or deep venous system extra effectively whereas sustaining a wonderful security profile due to Lightning’s computer-aided algorithms,” stated Dr. James F. Benenati, CMO at Penumbra. “We imagine that sufferers can have improved outcomes with this new expertise due to the distinctive trackability and distinctive skill to differentiate flowing blood from clot.”

Extra on the Penumbra Lightning Flash design

Penumbra’s Engine powers the Lightning Flash to make use of each strain and flow-based algorithms. These detect blood clot and blood circulation.

The corporate made the system’s catheter with MaxID hypotube expertise. This expertise permits for an inside diameter much like large-bore catheters. Nevertheless, it maintains a decrease profile with a tender, atraumatic tip for navigating the anatomy of the physique.

When all mixed collectively, the machine helps take away blood clots whereas minimizing potential blood loss, Penumbra stated.

The pc-aided system contains a part of the Penumbra Indigo system throughout the Lightning portfolio. Penumbra President of Interventional, Sandra Lesenfants, famous that these improvements have a “vital influence” on sufferers. She stated they “will proceed to rework the usual of take care of these troublesome situations.”

“Lightning Flash will essentially change how blood clots are faraway from the physique,” stated Adam Elsesser, president and CEO of Penumbra. “With this newest development, physicians usually tend to undertake mechanical thrombectomy as a result of a broad spectrum of blood clots may be eliminated a lot faster and fewer invasively than present interventional or surgical strategies. Which means we’re in a position to assist much more sufferers with our expertise, which is core to who we’re as an organization.”



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