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 wins CE Mark for bioresorbable DESolve stent
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.
HRS13: Endosense’s force-sensing ablation catheter
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.
Valve-in-valve implantation for failed heart valves shows good short-term results
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.
St. Jude Medical kicks off renal denervation device study
The 1st patient enrolled today in a St. Jude Medical (NYSE:STJ)-sponsored trial to evaluate the safety and performance of a new renal denervation system in patients with drug-resistant, uncontrolled hypertension, the company said.
HRS2013: Sorin’s dual-chamber ICDs boast lower inappropriate shock rates
Patients with Sorin Group (BIT:SRN) dual-chamber implantable cardioverter defibrillators had significantly fewer inappropriate shocks than patients with standard single-chamber devices, according to new clinical data.
HRS2013: Boston Scientific touts battery life data
Recent study data proves longer battery life of Boston Scientific‘s (NYSE:BSX) implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators, helping keep patients out of the hospital and reduce risk of infections and complications, the company claimed last week.
HRS13: Medtronic to seek expanded CRT indication on biventricular pacing data
Allergan poised for 2013 launch pending novel FDA OK for facial filler
FLASH: FDA panel votes in favor of Allergan’s Juvederm Voluma XC facial filler
An FDA advisory panel voted today to recommend approval for Allergan’s (NYSE:AGN) Juvederm Voluma XC dermal filler for aesthetic volume restoration in the mid-face.
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.
FDA advisors look to Hurricane Katrina, Japanese tsunami for lessons in protecting medtech systems
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.