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Penumbra (PEN) Gets FDA Nod for RED 62, Grows Thrombectomy Line

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Penumbra, Inc. (PEN - Free Report) recently received FDA clearance for the RED 62 Reperfusion Catheter. Following this regulatory go-ahead, the company has also initiated commercial availability of the catheter throughout the United States.

RED 62 is the latest addition to the company’s comprehensive Penumbra System, which enables physicians to perform mechanical thrombectomy in acute ischemic stroke patients with intracranial large vessel occlusions. The Penumbra System is designed to utilize aspiration technique to safely and effectively remove stroke-causing blood clots from the brain. For investors’ note, the Penumbra System portfolio consists of the Reperfusion Catheters, 3D Revascularization Device, the Penumbra ENGINE aspiration source and other accessories.

RED 62 is a next-generation catheter in the RED series, intended to bolster Penumbra’s aspiration thrombectomy solutions portfolio for stroke management. It is a cost-saving device that utilizes aspiration thrombectomy to remove blood clots and improve patient outcomes.

More About RED 62 Catheter

Penumbra’s RED 62 offers optimized trackability and aspiration technology to navigate through the complex distal vessels of the brain. Its extended length and low diameter profile is capable of reaching the target vessel. It aids the removal of blood clots in acute ischemic stroke patients with large vessel occlusions combined with the Penumbra ENGINE.

Industry Prospect

Per a report published in MarketsandMarkets, the global thrombectomy devices market is expected to witness a CAGR of 6.7% by 2022. The market is segmented into peripheral vascular, and neurovascular segments based on application. Increasing adoption of minimally invasive procedures, including thrombectomy procedures, growing target patient population, technological advancements, medical reimbursements and increasing expenditure in healthcare across emerging markets, are key factors fueling market growth.

Zacks Investment Research

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Given the substantial market prospects, Penumbra’s recent FDA authorization for RED 62 catheter seems well-timed.

Notable Developments

Penumbra initiated commercialization of the Indigo System Lightning 7 in the United States in March 2021, enabling physicians to address single-session arterial thrombus removal. The Lightning 7 integrates the new Indigo System CAT7 Aspiration Catheter with Lightning Intelligent Aspiration powered by the Penumbra ENGINE. It is expected to build on Penumbra’s offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy.

The company reported record results for its coronary thrombectomy system CAT RX in its earnings call for the first quarter of 2021.  The CAT RX was also authorized by the Society of Cardiovascular Angiography and Interventions as a viable option for treating large thrombus burden in saphenous vein grafts.

In its earnings call, the company also reported its Peripheral Embolization business exhibiting nearly 20% year-over-year growth in the United States, with both new and existing physicians and patients driving growth in the overall franchise. Its unique portfolio of products includes the latest Ruby Low Profile, which recorded significant contribution to the Peripheral Embolization business.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 63.7% compared with the industry’s growth of 25.2%.

Zacks Rank and Key Picks

Currently, Penumbra carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include PetIQ, Inc. (PETQ - Free Report) , IDEXX Laboratories, Inc. (IDXX - Free Report) and Intuitive Surgical, Inc. (ISRG - Free Report) .

PetIQ, sporting a Zacks Rank # 1 (Strong Buy), has a long-term earnings growth rate of 25%. You can see the complete list of today’s Zacks #1 Rank stocks here.

IDEXX, carrying a Zacks Rank # 2 (Buy), has a long-term earnings growth rate of 19.60%.

Intuitive Surgical, carrying a Zacks Rank # 2, has a long-term earnings growth rate of 9.40%.

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