Cardiovascular Systems (CSI) has secured approval for its Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown from the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).
FDA approval allows the device to be used to enable stent delivery in coronary artery disease (CAD) patients who are candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting related to de-novo, severely calcified coronary artery lesions.
Regulatory approval in Japan recognises the device as a frontline treatment for de-novo severely calcified lesions and to allow access to arteries for percutaneous coronary interventions (PCI).
The atherectomy system is designed to pilot tight, calcific lesions and treat vessels of various sizes, as well as provide continuous blood flow during treatment.
The diamond-coated tip enables instant access through tight, severely calcified lesions and treatment of up to 4mm vessels, while the sanding crown's increased mass facilitates lower rotational speeds.
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CSI chairman, president and chief executive officer Scott Ward said: "We are committed to continued advancement of CSI’s proven OAS technology focused on severe coronary arterial calcium, which is an underserved problem in vascular medicine.
"Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to worse clinical and economic outcomes.
"The ORBIT II and COAST studies demonstrated that orbital atherectomy technology is safe and effective in treating patients with severely calcified lesions."
The Harmonisation-By-Doing COAST trial was conducted in the US and Japan under the regulations of both governments.