Medtronic (NYSE:MDT) said today that lead material used in its cardiac leads, NASA Langley Research Center-Soluble Imide, was inducted into the Space Technology Hall of Fame. The induction ceremony took place at the Space Foundation’s 32nd Space Symposium in Colorado Springs, Colo. The material, originally developed as an insulation material used for space applications, high-performance engines […]
Cardiac Implants
FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale. The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, a nitinol and polyester mesh “double […]
FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs […]
FDA clears Medtronic’s miniature Micra transcatheter pacer
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker. The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle […]
Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device
Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization. Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial […]
LivaNova launches Perceval valve trial
LivaNova (NSDQ:LIVN) said today the 1st patient in the Persist-AVR trial of its Perceval sutureless aortic valve was implanted with the device at Nancy, France’s University of Lorraine. The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the […]
Video: Researchers develop “bionic” heart patch
Researchers at the University of Tel Aviv had developed a proof-of-concept “bionic patch” designed to monitor and treat heart conditions in real time, according to a report from Reuters. The patch features engineered, functional tissue integrated with electronics and is designed to give doctors new options for treating myriad heart problems. Findings from the development of […]
St. Jude wins CE Mark for expanded suite of cardiac leads
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads. The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said. “Heart and blood vessel anatomy vary […]
Stentys wins CE Mark for Xposition S self-apposing coronary stent
Stentys SA (EPA:STNT) said today it won CE Mark approval in the European Union for its self-apposing coronary Xposition S sirolimus-eluting stent, claiming it to be the “world’s 1st and only self-apposing coronary stent.” The approval came based upon results from a study of the device published last year in the journal Catheterization and Cardiovascular […]
Direct Flow launches next-gen TAVI delivery system in the EU
Direct Flow Medical today announced the European launch of its next-gen DirecTrack Delivery System designed for its Direct Flow transcatheter aortic valve system. The new system features improved ergonomics and functionality for greater control during the implantation procedure, the Santa Rosa, Calif.-based company said. “We’re pleased to provide physicians with this latest advance in TAVI procedural […]
V-Wave touts 1st-in-human for interatrial shunt
V-Wave today released results from the 1st-in-human implantation of its investigational interatrial shunt device designed for patients with advanced heart failure, touting a 100% success rate for implantation and no device-related adverse events. The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, where a valve regulates left to right shunting of […]