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.
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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.
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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.
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