Cardiovascular System's (CSII) OAS Cures 1st Patient in Europe

Cardiovascular Systems, Inc. CSII announced the first commercial use of the Diamondback 360 Coronary Orbital Atherectomy System (OAS) in Europe. The first patient in Europe has been successfully treated with Diamondback 360 Coronary OAS.

For investors’ note, Diamondback 360 is designed to treat all calcium modalities, including nodular, eccentric (irregular) and concentric (ring-shaped). This device also includes GlideAssist, which allows for tracking, easier removal and smoother repositioning of the device – especially in difficult patient cases.

Notably, Diamondback 360 Coronary OAS is FDA-approved and received CE Mark in January 2021, which enables the company to expand presence in the European market.

With the latest achievement, Cardiovascular Systems is likely to strengthen its coronary artery disease (CAD) products business on a global scale.

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Per personnel associated with this field, patients suffering with calcific coronary artery disease have poor clinical results. The use of Diamondback 360 Coronary OAS streamlines the treatment with a unique mechanism to successfully modify severe calcium and optimize stent performance.

Per a clinical study of CSI’s ORBIT II and COAST, Diamondback 360 Coronary OAS is safe and effective in treating patients with de novo severely calcified coronary lesions. Also, the two real-world studies with approximately 1000 patients have highlighted Diamondback’s safety, high procedural as well as long-term clinical success.

The introduction of Diamondback 360 Coronary OAS enables physicians in Europe to treat patients with calcific coronary artery disease. Also, Cardiovascular Systems is preparing to launch the product leveraging streaming platforms to train and support physicians and their cardiologist teams remotely.

Notable Developments in CAD Arm

Cardiovascular Systems has been witnessing growth in its CAD business over the past few months.

The company, during its second-quarter fiscal 2021 earnings call in February 2021, reported a 13% increase in coronary segment revenues compared with the previous quarter. With the large retrospective observational study of coronary orbital atherectomy highlighting safety and high procedural and clinical success of Diamond 360 Coronary OAS, company is expecting to witness wide acceptance of OAS device across the globe.

In January 2021, Cardiovascular Systems announced the receipt of the CE Mark for its Diamondback 360 Coronary Orbital Atherectomy System (“OAS”) and ViperWire Advance Coronary Guide Wire with Flex Tip (ViperWire Advance with Flex Tip). The approval allows the company to expand presence in the untapped European market.

Industry Prospects

Per a report by MarketsandMarkets, the global atherectomy devices market was valued at $1.08 billion and is projected to reach a worth of $1.45 billion by 2022, at a CAGR of 6.1%. The market is primarily growing on an expanding target patient population, continuous product development and commercialization, favorable medical reimbursements, and rising demand for minimally-invasive atherectomy procedures.

Price Performance

Over the past six months, shares of the company have gained 38% compared with the industry’s growth of 16.8%.

Zacks Rank and Key Picks

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

Some better-ranked stocks from the broader medical space are Abbott Laboratories ABT, Meridian Bioscience, Inc. VIVO and Myomo, Inc. MYO, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Abbott Laboratories’ long-term earnings growth rate is estimated at 14.6%.

Meridian Bioscience’s long-term earnings growth rate is projected at 14%.

Myomo’s long-term earnings growth rate is estimated at 22.5%.

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