LONDON, UK (GlobalData), 28 March 2012 - Blue Medical, a company focused on the treatment of cardiovascular diseases, announced last week the launch of their CE approved drug eluting balloon (DEB) Protégé. This marks another entry into a new and exciting market within the interventional cardiology industry. Current players with CE approval in the DEB market include B.Braun, Eurocar and Invatec.
Drug eluting balloons are used in the treatment of coronary in-stent restenosis, which occurs when blockages appear at a site where bare metal stents (BMS) or drug eluting stents (DES) have been implanted in the blood vessel. As reported in the New England Journal of Medicine, the incidence of in-stent restenosis ranges from 5% - 35% following the implantation of a BMS, while the incidence rate is somewhat lower for a DES. Interventional cardiologists often treat in-stent restenosis by introducing an additional stent inside the occluded stent, but DEBs look to be a rising alternative in the EU. Through the use of a catheter, the DEB is introduced to the site of the blockage, and is expanded to reopen the area. The balloons are coated with paclitaxel, an anti-proliferative drug which limits the growth of scar tissue at the site of the occlusion. Although DEBs have yet to be approved by the FDA in the US, there are numerous ongoing clinical trials.
Earlier this month, B. Braun’s SeQuent Please DEB showed superiority for the treatment of restenosis as compared to angioplasty balloons not coated with paclitaxel. The trial followed 110 patients for six months, and found that patients treated with DEB suffered less late lumen loss. This represents the difference between the minimum lumen diameter immediately after stenting, and at a six month follow up. In addition, patients treated with DEB had a significantly lower incidence of cardiac death, target vessel myocardial infarction (MI) and target lesion vascularization.
Gerd Wacker, vice president of B. Braun Vascular Systems, said, “SeQuent Please is a very exciting development for the cardiological community. With the current clinical evidence, SeQuent Please can be considered as a reasonable alternative to drug-eluting stents for selected patients with coronary artery disease; it is the most advanced solution for the treatment of patients with ISR and it represents currently the most promising therapeutic alternative to reduce the number of unnecessary stent implantations.”
The World Health Organization estimates that by 2030, 23.6 million people will suffer from cardiovascular disease. DEBs have the potential to be adopted for new indications in small vessel disease, bifurcated lesions, DES restenosis and PVD, which GlobalData believes could represent a $2 billion global market potential.
This expert insight was written by GlobalData's Head of Medical Devices, Derek Archila. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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