ClearStream's balloon catheters
This article was originally published in Clinica
Executive Summary
Enniscorthy, Ireland-based ClearStream Technologies has received 510(k) approval from the US FDA for its percutaneous transluminal angioplasty balloon catheters. The catheters will be marketed in the US by Cordis, under the brand names Sleek and Savvy Long. The Sleek device is designed for use in infrapopliteal vessels, while the Savvy Long provides an over-the-wire alternative for both superficial femoral and infrapopliteal arteries. The approval covers the full range of the products' balloon sizes and will include the longest PTA balloons on the worldwide market: 40-220mm lengths for Sleek, and 120, 150 and 220mm lengths for Savvy Long. Both products are expected to launch in the US in the first half of 2008; the launch will be the first time these balloon lengths will be available in the country. Both catheters have already been launched outside the US, ClearStream CEO Andrew Jones told Clinica. They are marketed in Europe as Sleek and Savvy Long, but also under the brand names LitePAC and Bantam, respectively.