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Cardiovascular Systems Gains From 510K for OrbusNeich Device

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Cardiovascular Systems Gains From 510K for OrbusNeich Device

Cardiovascular Systems (CSII) to distribute limited editions of both 1.0-4.0mm Sapphire II PRO and 2.0-4.0mm Sapphire NC Plus non-compliant coronary balloons post the product launches in the market.

Cardiovascular Systems, Inc. CSII has recently announced that OrbusNeich’s 1.0mm Sapphire II PRO coronary balloon has secured 510(k) clearance from the FDA. The company is the exclusive distributor of OrbusNeich’s balloon products since January 2018. Accordingly, this 510(k) clearance is a major step toward the company gaining expansion to its scope of distribution.

Headquartered in Hong Kong with operations in Shenzhen, China, OrbusNeich is a balloon technologies company, particularly catering to the fields of percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The 1.0mm Sapphire II PRO coronary balloon by OrbusNeich is claimed to be the first and the only 1.0mm coronary balloon available in the United States. The product offers entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions.

Per Cardiovascular Systems, this 1.0mm balloon complements the company’s orbital atherectomy system in treating complex and high-risk indicated patients.

Post the launch, Cardiovascular Systems is going to distribute both the 1.0-4.0mm Sapphire II PRO as well as the 2.0-4.0mm Sapphire NC Plus non-compliant coronary balloons on a limited basis. The company also expects OrbusNeich’s full balloon product portfolio to be available in the United States throughout 2018 and 2019.

Market Prospects

Cardiovascular Systems firmly stands to gain as a distributor of coronary balloons from several favorable trends existing in the peripheral arterial disease (PAD) as well as coronary arterial disease market spaces. According to estimates delivered by American Heart Association, as many as 8-12 million Americans suffer from PAD. Moreover, an aging population coupled with the increasing incidence of diabetes and obesity, is likely to propel the prevalence of PAD further. This in turn also offers a huge scope to the unique PAD Orbital Atherectomy System system of Cardiovascular Systems.

Per a report by Transparency Market Research, the global market for coronary heart diseases is expected to witness a surge in demand due to the rising instance of chronic diseases. Going by Technavio data, this market is likely to witness a CAGR of more than 5% by 2021.

Price Comparison


Over the past six months, Cardiovascular Systems has underperformed the broader industry. The stock has declined 25.2% against the 6.4% rise of the broader industry. Strategic developments like these are anticipated to help reviving the company’s share price trend to some extent.

Zacks Ranks & Key Picks

Cardiovascular Systems carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the broader medical space are athenahealth, Inc. ATHN, Centene Corporation CNC and Mednax, Inc. MD, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

athenahealth has a projected long-term growth rate of 20.7%. The stock has returned 10% in the past three months.

Centene has a long-term growth rate of 14.4%. The stock has rallied 18.9% in the past six months.

Mednax has an expected long-term growth rate of 10%. In the past six months, the stock has jumped 26%.

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