Balloon Dilatation Catheter Cleared by FDA

Food and Drug Administration (FDA). Called the R1, the catheter is the product of Medtronic, Inc. (Minneapolis, MN, USA).

The R1 enjoys the same features as its over-the-wire counterpart, the D1 balloon catheter. These include a hydrophilic coating, intelligent balloon folding, and a flexible, tapered tip design. The coating is designed to provide the right balance of lubrication and traction, so the balloon can cross lesions more easily. The folding technology helps create one of the lowest crossing profiles for single or repeated inflations, and the novel tip of the R1 enables the balloon to track smoothly across the guidewire and cross the lesion.



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Medtronic, Inc.