The Serranator® Alto PTA Serration Balloon Catheter
The Serranator® Alto PTA Serration Balloon Catheter (Figure 1) is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty for peripheral vasculature as described in the indications for use statement. The Serranator® Alto has a nylon semicompliant balloon with four embedded external serrated metal strips. The serrated strips are designed to create linear, interrupted scoring (Figure 2) along the endoluminal surface during balloon angioplasty.
Indications For Use
The Serranator® Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature. The Serranator® Alto received 510(k) clearance from the US Food and Drug Administration in February 2017.
The Serranator® Bass, currently in development, will be intended for below-the-knee arteries.
• 0.018” guidewire compatible
• 6 F sheath compatible
• Semicompliant balloon
• 150 cm catheter length
• 4.0, 5.0, and 6.0 mm balloon diameters
• 40, 80, and 120 mm balloon lengths