ClearStream's balloon catheters
This article was originally published in Clinica
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.
You may also be interested in...
As of 5 February, the Scientific Committee on Consumer Safety is evaluating use of titanium dioxide – now officially classified as a Category 2 carcinogen in the EU – in cosmetic products that can expose consumers by way of inhalation. Without a favorable SCCS opinion, the ingredient’s use in those contexts will be banned under Article 15 of the Cosmetics Regulation.
Nanobiotix’s CEO outlines to Scrip how the biotech plans to develop and expand its lead asset into multiple cancer indications, and create a blockbuster.
Two late-stage trials of Austedo have missed their endpoints in the neurological disorder, meaning Teva will miss out on an additional revenue stream from the VMAT2 inhibitor.