Arrhythmia Research Technology‘s (NYSE:HRT) Signal-Averaged Electrocardiography device is 1 of only 2 ECG tests that can predict ventricular arrhythmias in patients with prior heart attacks, data from an NIH-funded multi-center clinical trial proves.
Elixir Medical’s DESolve Novolimus eluting bioresorbable coronary scaffold system won European CE Mark approval, the privately held Sunnyvale, Calif.-based company announced today.
DESolve is designed to degrade in about 1 year, returning the patients’ coronary vessel to its normal de novo state.
Elixir plans to initiate commercial sales of DESolve in a broad range of sizes in select international markets later this year, according to a press announcement.
Geneva-based Endosense’s proprietary contact force technology improves efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, according to new study data released last week at the annual Heart Rhythm Society meeting.
The short-term results of minimally invasive transcatheter valve-in-valve implantation to treat failed biological heart valve protheses are "excellent," but patients must be closely monitored due to some notable cases of suboptimal systolic-valve performance, according to early data from a multi-center trial.
The FDA’s General & Plastic Surgery Devices advisory panel unanimously decided that the injectable gel is safe, effective and that its benefits outweigh its risks.
An FDA panel on April 11 advised the federal watchdog agency to take another look at its emergency risk mitigation strategies, particularly in regard to how events like extreme weather and natural or nuclear disasters may threaten medical devices.