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 […]
Cardiac Implants
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 […]
CorMatrix launches U.S. tricuspid valve device trial
CorMatrix Cardiovascular said today it enrolled the 1st patient in a trial of its CorMatrix ECM tricuspid valve designed from regenerative tissue. The early feasibility trial aims to demonstrate proof of principle and initial clinical safety at 8 U.S. centers, the Roswell, Ga.-based company said. CorMatrix is performing the trial under an investigative device exemption […]
UPDATE: FDA: Abbott’s Mitraclip safety notice is Class I
Updated with information from an Abbott spokesperson. The FDA today issued a Class I recall label for the safety notice Abbott (NYSE:ABT) issued for its MitraClip device over issues in which the clip delivery system could not be detached from the clip due to a malfunction. Class I recall designations, the agency’s most serious classification of recall, […]
UPDATE: FDA panel OKs Abbott’s Absorb stent
UPDATED March 16 with comments from panel members. An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott (NYSE:ABT). The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-0, with one abstention, on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus […]
Structural heart: Nobles Medical, HeartStitch tout cardiac suture procedures
Structural heart focused HeartStitch and Nobles Medical today touted separate procedures utilizing cardiac sutures with the company’s Hearstitch ST and Noblestitch EL devices. Nobles Medical Tech said that the NobleStitch EL device was used in the 1st percutaneous ASD closure and ASA repair and remodeling without the use of an implantable device. The NobleStitch EL device […]
St. Jude Medical’s Nanostim leadless pacemaker wins MR-conditional CE Mark
St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for its Nanostim leadless pacemaker. Little Canada, Minn.-based St. Jude said the approval covers MR-conditional labeling for full-body, 1.5-Tesla scans. “The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” chief medical officer […]
LivaNova touts 1st U.S. implants of Perceval sutureless valve
LivaNova (NSDQ:LIVN) today announced the 1st U.S. implantation of its Perceval sutureless aortic valve replacement. The implantation, which took place last week, was headed by Dr. Douglas Johnson and Dr. Eric Roselli at the Cleveland Clinic in Ohio, with the patient receiving 2 valves during the operation. “The availability of a sutureless valve optimizes surgical options to treat aortic […]
FDA warns on mag interference between breast expanders, ICD/pacers
The FDA today released a letter warning on magnetic interference issues between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators or pacemakers. The federal watchdog warned that it has received reports of the 2 devices interacting in a way that interferes with the function of the cardiac implants, but that the issue presents a very […]