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Non‐compliant balloon catheters

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Non‐compliant (NC) balloons, unlike semi‐compliant balloons, tolerate high inflation pressures, exhibiting a small increase in diameter. NC balloons allow more uniform balloon expansion and the application of higher forces in a focal segment of a coronary vessel, avoiding dog‐bone deformation exerting excessive pressure at the edges and potentially causing coronary dissections or perforations. When facing a mild to moderate calcific coronary lesion, repeated and prolonged inflations with NC balloons should be encouraged as the first choice, especially when the calcium arc is restricted (<90°).

Sapphire II (OrbusNeich, Hoevelaken, Netherland), a last generation NC balloon, is a well‐balanced balloon catheter that crosses lesions without boundaries. This catheter offers an ultra‐low crossing profile across a broad range of configurations, including 1.0 mm diameter balloons and 150 cm shaft working length versions. Sapphire II features a flexible, supple balloon material for slender rewrap; an XD (eXtra Durable) shaft for enhanced pushability and superb kink resistance; proprietary Hydro‐X coating for lubricious crossing; and Z‐Tip technology resulting in ‘Zero’ transition between the tip and guidewire for smooth and safe penetration of the tightest of lesions.

The OPN NC balloon (SIS Medical) is a double‐layered balloon that allows high‐pressure dilatation. This balloon catheter uses twin‐layer technology to allow super high pressures within the balloon with minimal increases in diameter. This balloon can be inflated with a nominal pressure of 10 atm and a rated burst pressure of 35 atm, but the balloon was tested up to a pressure of 45 atm and many operators report very rare balloon ruptures at pressures as high as 5573 kPa 55 atm, the maximal level allowed by the special indeflator provided with the balloon. The OPN NC balloon is available in diameters ranging from 1.5 to 4.5 mm (in 0.5 mm increments) and lengths of 10, 15, and 20 mm. The OPN NC balloon is a dedicated device for the treatment of in‐stent restenosis, heavily calcified lesions or other lesions that cannot be dilated. The OPN balloon is compatible with 0.014 inch wires and 5 Fr access, but it has a high profile (0.028 inches), although this is better than scoring and cutting balloons, and so it is difficult to recross or reuse after inflation. In a retrospective study evaluating 326 undilatable lesions in which conventional NC‐balloons failed to achieve adequate post‐dilatation luminal gain, the OPN NC balloon successfully treated >90% of undilatable lesions compared with a conventional NC balloon with a 0.9% rate of coronary rupture, resulting an effective and safe strategy for treatment of severe resistant coronary lesions [28].

Interventional Cardiology

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