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.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.