AtriCure wins FDA OK to launch post-approval clinical study of AF ablation
AtriCure (NSDQ:ATRC) won FDA approval to launch a post-approval clinical study of its Synergy radiofrequency ablation system in treatment of non-paroxysmal atrial fibrillation, a chronic and hard-to-treat heart disease.
The new 3-year, 350-patient ABLATE study follows the West Chester, Ohio-based device maker’s December 2011 FDA win for the Synergy ablation system, indicated for treatment of AF during open-heart surgery.
Previous Synergy studies found that 84% of patients were free from AF at 6 month following treatment, and 75% remained AF-free at 22 months.
The device was the 1st surgical ablation system approved by the federal watchdog agency for treating AF (other, catheter-based techniques have already gotten an FDA nod) and the 1st approved for treating persistent and long-standing persistent AF, according to AtriCure. The FDA already cleared the Synergy device for cardiac ablation during concomitant open-heart surgical procedures.
ATRC shares were down 4% to $7.57 as of about 1:30 p.m. today.
Sorin wins China regulatory approval for suite of pacemakers
Sorin Group (BIT:SRN) won approval from China’s State Food & Drug Administration for the Reply and Esprit families of pacemakers, which boast some of the industry’s smallest devices and proprietary safety features that prevent unnecessary shocks to the heart.
Teleflex touts FDA clearance for latest Arrow catheter
Teleflex (NYSE:TFX) won FDA clearance for the latest in its line of Arrow peripherally inserted central catheter devices, now pre-loaded with the Arrow VPS vascular positioning system. The device replaces chest X-rays by using real-time intravascular Doppler, ECG and advanced algorithms for detecting the location of the catheter tip.