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Coronary dilatation catheters receive FDA clearance

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OrbusNeich announced that a line of coronary dilatation catheters for the treatment of patients with acute MI and coronary ischemia has received 510(k) clearance from the FDA and has launched in the United States.

The two catheters (Sapphire II PRO and Sapphire NC Plus, OrbusNeich) can be used for the balloon dilatation of a coronary artery occlusion during treatment for MI, or the stenotic portion of a coronary artery or bypass graft stenosis or, according to a press release from the company.

Sapphire II Pro has a tapered tip with a low profile, allowing it to enter difficult lesions, and a balloon (XR balloon, OrbusNeich) to cross lesions without affecting durability, according to the release.

The noncompliant balloon material of the Sapphire NC Plus has a folding mechanism (TiFo, OrbusNeich) enabling clinicians to easily cross lesions, and coating (Hydro-X, OrbuxNeich) allows for improved lubricity and passability, the company stated in the release.