Medical device maker ClearStream Technologies Group PLC (AIM: CTN) announces an extension of the indication for its Intrepide drug eluting stent.
The company said in a statement it received confirmation from its testing and certification body KEMA, that KEMA has given its approval to extend the indication for the Intrepide DES, as clinical data provided has supported the indication for 'Suitability and Efficacy of Intrepide DES in Diabetic Patients'.
The Intrepide stent uses anti-proliferative and anti-inflammatory drug Trapidil as its active agent. Unlike other DES that use cytotoxic or cytostatic drugs, Intrepide may have a significantly lower instance of late stent thrombosis, improving long term safety and efficacy and reducing the need for long term dual anti-platelet therapy, Clearstream said.
In clinical practice, diabetes is usually considered an important risk factor for major adverse events after implantation of drug eluting stent.
Dr Mazhar Khan, Consultant Interventional Cardiologist in Belfast and a clinical advisor to Clearstream, commented “the addition of this indication to the Intrepide DES provides interventional cardiologists the opportunity to treat cardiovascular disease in diabetics with the potential of lower long-term risk to the patient specially those who can not take prolonged dual anti platelet therapy”.