In short
Canadian approvals are obviously like London buses. We haven’t seen reports of any for ages and then two come along in the same week. First we heard about Medtronic’s approval for use of its Deep Brain Stimulation(DBS) therapy in the treatment of refractory epilepsy, hot on the heels of which came Boston Scientific’s announcement that its Blazer™ Open-Irrigated Catheter had gained Health Canada’s approval and would be launched immediately.
Deep Brain Stimulation for Refractory Epilepsy
Earlier this week we covered here the commencement of the MedtrOnic Registry for Epilepsy(MORE) in Europe, which is designed to look at the long-term efficacy, quality of life impact and safety of deep brain stimulation (DBS) in patients with refractory epilepsy.
Despite not being approved for this indication in USA, Health Canada has cleared the therapy based on the findings of the “Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy” (SANTE) study undertaken in 17 US centres involving 110 patients. The SANTE trial was a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures.
Medtronic’s press release can be found here.
Radiofrequency Ablation for Arrhythmias
According to a press release, Health Canada has approved Boston Scientific’s Blazer™ Open-Irrigated Catheter, the Company’s latest radiofrequency ablation (RFA) catheter designed to treat a variety of arrhythmias such as atrial fibrillation, atrial flutter, ventricular tachycardia and other supraventricular tachycardias.
Cardiac Ablation in the treatment of atrial fibrillation is being used increasingly for patients who cannot tolerate anti-arrhythmic medications. The Blazer Open-Irrigated Catheter is a Radiofrequency-based system that integrates what the company calls its Total Tip Cooling™ Design, which is intended to consistently cool the entire tip electrode during radiofrequency energy delivery, resulting in reduced coagulum at the proximal edges of the tip.
The Blazer Open-Irrigated Catheter is already CE Mark approved, while in USA it remains an investigational device only at this time.
The full press release can be found on Device Space here.
Source: Medtronic, Boston Scientific, Device Space
published: March 16, 2012 in: Approval/Clearance, Boston Scientific, Cardio, Medtronic, Neuro, News, Regulatory