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FDA approves Cardiovascular Systems to initiate ORBIT II coronary clinical trial

The US Food and Drug Administration (FDA) has approved Cardiovascular Systems to complete enrollment of 429 patients in its ORBIT II investigational device exemption (IDE) clinical trial for a coronary application for its Diamondback 360 System.

The Diamondback 360° is designed for removing calcific and fibrocalcific plaque in coronary lesions.

The system uses a diamond-coated crown with a orbital mechanism of action to sand and remove hardened plaque, which may facilitate more effective stent placement and restoration of blood flow in the coronary arteries.

The orbital action also allows continuous saline and blood flow through the lesion, which may be advantageous during treatment.

The approval came following FDA review of data from the first 50 cases, as called for in the trial protocol.

Cardiovascular Systems has also received conditional approval from the FDA to use ViperSlide lubricant in the ORBIT II study.

President and CEO David Martin said use of the Diamondback 360° device in small, calcified coronary arteries facilitates effective stent placement, or avoid the trauma and cost of heart bypass surgery.

"This was demonstrated by the safety and efficacy data from our ORBIT I coronary feasibility trial, and we are confident we will have similar results in ORBIT II," Martin said.

Cardiovascular Systems’ other products include Stealth 360°, Diamondback Predator 360 Orbital PAD Systems