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Onset's SoloPath transseptal catheter:

This article was originally published in Clinica

Executive Summary

Onset Medical has CE marked its SoloPath percutaneous transseptal access catheter for sale in Europe, and plans to market it in the EU and "select countries worldwide". The catheter uses the Irvine, California-based firm's controlled deployment technology (CDT) to allow surgeons to access the left atrium and pulmonary veins. The diameter of the catheter when it enters the body is around 50% of the size of conventional access devices, Onset claims, but once positioned, it can be expanded to maintain access to the treatment site, creating an internal diameter larger than conventional devices. SoloPath received US FDA 510(k) clearance in March 2007 (see Clinica No 1249, p 22).

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