Cardiovascular Systems' (CSII) OAS Gets CE Mark for Use in Europe

Cardiovascular Systems, Inc. CSII recently 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 enables the company to tap into the largely underpenetrated European patient pool, thus expanding its presence.

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

With the latest regulatory approval, Cardiovascular Systems aims to strengthen its coronary artery disease (“CAD”) products business on a global scale.

Significance of the Approval

Per personnel associated with this field, the Diamondback 360 Coronary OAS provides a unique solution to optimize stent delivery, expansion and wall apposition (or positioning) for safer procedural results. Further, the usage of the system ensures long-term clinical results in highly complex body types as well.

Another field expert is optimistic about the adoption of the OAS as the latest tool to improve treatment outcomes for older patients with more complicated coronary diseases. Per estimates, around 12% of percutaneous coronary intervention (“PCI”) patients suffer from significant calcific coronary disease (calcium build-up within the walls of the arteries), which is more prevalent in aged patients and those who are smokers, diabetics or suffer from renal dysfunction. Such patients possess a higher risk of procedural complications along with unfavorable long-term results post PCI.

Thus, the OAS is believed to be the relevant alternative to expand the treatment options in cases of complex patient anatomies.

Per management, the receipt of the CE Mark will enable the company to collaborate with European physicians with respect to expanding the treatment options for patients suffering from severely calcified coronary artery disease.

Industry Prospects

Per a report by Research And Markets, the global CAD treatment devices market is projected to grow at a CAGR of approximately 5.5% between 2018 and 2024. Factors like the rising incidence of cardio vascular diseases and the growing elderly population are expected to drive the market.

Given the market potential, the recent regulatory approval is expected to significantly boost Cardiovascular Systems’ business worldwide.

Notable Developments in CAD Arm

Cardiovascular Systems has been witnessing a few developments across its CAD business over the past few months.

The company, during its first-quarter fiscal 2021 earnings call in November 2020, recorded a better-than-expected recovery in coronary procedures. This indicated positive trends in the patient referral channels and the indispensable attributes of orbital atherectomy.

Cardiovascular Systems, in October 2020, presented favorable results from a large retrospective observational study of coronary orbital atherectomy. The study illustrated excellent safety and high procedural success with the Diamondback 360 Coronary OAS.

Price Performance

Shares of the company have lost 16.7% in the past year against the industry and the S&P 500’s 3.6% and 14.9% growth, respectively.

Zacks Rank & Key Picks

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

Some better-ranked stocks from the broader medical space are Hologic, Inc. HOLX, IDEXX Laboratories, Inc. IDXX and Patterson Companies, Inc. PDCO.

Hologic’s long-term earnings growth rate is estimated at 17.4%. The company presently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

IDEXX’s long-term earnings growth rate is estimated at 15.8%. It currently carries a Zacks Rank #2 (Buy).

Patterson Companies’ long-term earnings growth rate is estimated at 11.1%. The company presently carries a Zacks Rank #2.

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