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Medtronic: FDA Okays Solitaire Device for Expanded Use

MDT BAX NXTM BVX

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Medical device major, Medtronic plc (MDT - Free Report) recently announced FDA approval for an expanded indication of its Solitaire stent retriever device. This allows the marketing of the Solitaire device as an initial therapy for acute ischemic strokes (AIS) in patients with persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts to reduce paralysis, speech difficulties and other stroke-related disabilities. The tool should be used after patients have received intravenous tissue plasminogen activator (IV t-PA) and within six hours of symptom onset.

The Solitaire device uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing large blood clots causing AIS. Reportedly, stroke is the fifth major cause of death in the U.S. and the prime reason for severe disability. The availability and access to technology which reduces stroke disability is considered important. Of the 795,000 AIS patients in the U.S., about 240,000 are eligible for treatment with stent retrievers. However, only 22,000 procedures are performed annually.

Notably, FDA’s approval for the expanded indication was based on a subset of data from the Solitaire FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke(SWIFT PRIME) trial. Statistics show that the combination of Solitaire device and IV-tPA radically reduced post-stroke disability and increased the number of patients who were functionally independent with mRS scores of 0-2 within 90 days of a stroke (62.7% vs. 36.8%).

In Feb 2016, a meta-analysis of SWIFT PRIME found that Medtronic's Solitaire Stent Retriever Device when used with IV-tPAimproved functional outcomes for AIS and reduced death risk in patients above 80 years of age.

According to a Transparency Market Research report, the global AIS treatment and diagnosis market is likely to be worth $1,869.7 million by 2020. We can say that the expanded indication for the Solitaire device will boost growth of Medtronic’s neurovascular business (within Restorative Therapies Group) which at present is performing well. Management claims that it is the only company with a device covered by all the five global clinical trials that are striving to change the treatment of stroke as per the American Stroke Association guidelines. This opens up scope for Medtronic to cash in on the potential of the growing AIS treatment market.

Zacks Rank & Key Picks

Medtronic currently carries a Zacks Rank #3 (Hold). Better-ranked medical stocks are NxStage Medical Inc. (NXTM - Free Report) , Baxter International Inc. (BAX - Free Report) and Bovie Medical Corporation (BVX - Free Report) . NxStage Medical and Baxter International sport a Zacks Rank #1 (Strong Buy) while Bovie Medical carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

NxStage Medical surged 31.6% over the last one year compared to the S&P 500’s 6.3% over the same period. The company has a four-quarter average positive earnings surprise of 50.00%.

Baxter International rallied 20.9% in the past one year, much higher than the S&P 500’s 4.5%. It has a trailing four-quarter average positive earnings surprise of 27%.

Bovie Medical recorded a 126.5% gain in the past one year, way better than the S&P 500’s 4.5%. The company has a trailing four-quarter positive average earnings surprise of 28.7%.

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