Wexford-Based ClearStream Technologies Wins FDA Approval For Key New Product Line
Wexford-based ClearStream Technologies recently announced that it has received approval from the US Food and Drug Administration (FDA) for the sale in the United States of its ground-breaking ReekKross family of catheters.
ClearStream, an Enterprise Ireland client company, is an innovative designer and manufacturer of specialist medical devices including catheters and drug-eluting stents used in interventional procedures.
The ReeKross is used in the treatment of critical limb ischemia, a condition often caused by Diabetes and which, if left untreated, leads to amputation of the affected limb. It was developed under ClearStream's research and development programme which is supported by Enterprise Ireland.
Commenting, ClearSteam Technologies' CEO Andrew Jones said:
"This FDA approval is potentially one of the most exciting developments for ClearStream in that it enables us to supply the largest market in the world for peripheral catheters. It gives significant additional impetus to our drive to build and develop ClearStream as one of the world's leading suppliers of innovative devices for the treatment of critical limb ischemia and diabetic foot. US health-care systems are well developed and organised for interventional treatment of these conditions and we now have approval to supply some of the most effective products available on the market."
Brian O'Neill, Enterprise Ireland's Lifesciences Manager added:
"Innovation and R&D are central to success in today's competitive markets. ClearStream has always kept these at the heart of its competitive internationalisation strategy and Enterprise Ireland has been delighted to support the company's significant investment in research and development over the years.
"It is this investment that is now driving significant sales growth across a number of key international markets and has provided the company with a platform for continued differentiated expansion. This Enniscorthy based company is now poised to become a truly global brand and this achievement cannot be overstated."
In related news, ClearStream is today hosting an International User-Group Convention at St James Hospital, Dublin where doctors from across Europe will assess the performance of another of its ground-breaking product ranges, the Intrepide. The Intrepide, which was was developed with R&D support from Enterprise Ireland, is a drug-eluting stent (drug-emitting stent) which reduces the reclogging of coronary arteries, which commonly occurs after the implantation of traditional stents.
Andrew Jones said:
"This is an exciting period of growth for ClearStream Technologies and I am delighted to have the opportunity to showcase our progress at the convention in St James Hospital. These two product ranges, the ReeKross and the Intrepide, which were developed with significant support from Enterprise Ireland, demonstrate the company's innovation-led growth.
"We restructured our operations last year and the combination of a strong new product stream and improved cost base has significantly strengthened our business as a whole. We look forward to the continued development of the company and its range of market-leading products."
SOURCE: ClearStream Technologies Group plc