Penumbra (PEN) Enrolls First Patient in Landmark STORM-PE Trial
Penumbra PEN recently announced the enrollment of the first patient in the STORM-PE trial, the first-of-its-kind randomized controlled trial (RCT), which compares computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash with anticoagulation versus anticoagulation alone for the treatment of pulmonary embolism (PE). The trial is conducted in collaboration with the PERT Consortium — a multi-disciplinary group dedicated to improving the care of patients with PE.
Powered by Penumbra ENGINE, Lightning Flash is part of Penumbra’s Indigo Aspiration System with the Lightning portfolio. Lightning products are the only computer-aided mechanical thrombectomy systems currently available in the United States.
Significance of Lightning Flash
FDA-cleared, Lightning Flash is the most advanced and powerful mechanical thrombectomy system in the market to address venous and pulmonary thrombus. The innovation can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems and can be used for the treatment of PE.
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Lightning Flash combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration — a unique computer-assisted clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.
More on the News
According to Penumbra’s quoted estimates, an estimated 900,000 cases of symptomatic PE occur annually in the United States alone. Pulmonary embolism can be life-threatening, with 10-30% of individuals dying within one month of diagnosis. Penumbra prioritizes clinical research and innovation to lead with insight and continue to pioneer interventional therapies, such as CAVT technologies, that have a significant impact on patients.
The STORM-PE trial will enroll up to 100 participants at up to 20 sites. In partnership with the PERT Consortium, STORM-PE aims to advance the understanding of the role of CAVT in the management of acute PE, with the goal of improving the outcomes for patients with this life-threatening condition.
Industry Prospects
Per a Research report, the thrombectomy devices market was valued at $1.2 billion in 2021 and is expected to witness a CAGR of 6.8% up to 2028.
Other Notable Developments
Earlier this month, the company presented the late-breaking data from the STRIKE-PE trial, adding to the growing body of evidence that demonstrates the significant benefits of CAVT. The trial, evaluating Penumbra’s Indigo Aspiration System with Lightning, showed that CAVT is safe and effective in reducing right heart strain and also improved clinical outcomes and functional outcomes.
With the latest advancements in computer-aided technologies, Penumbra offers one of the most comprehensive mechanical thrombectomy product lines for arterial, venous, pulmonary and mesenteric thrombus. In June 2023, the company announced the FDA clearance and launch of Lightning Bolt 7. The latest technology combines modulated aspiration with superior catheter design to maximize blood clot removal in a single session.
Price Performance
Over the past year, shares of the company have increased 7.8% against the industry’s decline of 9.2%.
Zacks Rank and Other Key Picks
Penumbra currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are Haemonetics HAE, Insulet PODD and DexCom DXCM. Haemonetics and DexCom each presently carry a Zacks Rank #2, and Insulet sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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