SAPIEN 3 valve demonstrates low mortality, low paravalvular leakage and excellent 30-day outcomes In both patient cohorts
Cardio
FDA Approves Boston’s WATCHMAN™ Left Atrial Appendage Closure Device
First-Of-Its-Kind alternative to long-term Warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation
Pivotal Studies of Resolute Onyx™ Drug Stent Starts in Patients with Small Coronary Vessels
Medtronic’s DES with CoreWire technology to be studied in wide spectrum of patients, starting with those with the smallest coronary arteries
CE Mark for Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease
Philips’ newly acquired Volcano business has seen its iFR Scout Pullback software gain European regulatory approval
Trial of Biodegradable, Polymer Drug-Eluting Coronary Stent Completes Enrollment
Biosensors’ Chinese subsidiary JW Medical Systems is reporting completion of 432 patients
FDA Go-Ahead for CorMatrix Tricuspid Heart Valve Study
Extracellular Matrix looks like an ideal candidate for a tricuspid valve. New study should provide clinical support.
J&J Sells Cordis to Cardinal Health
Deal worth $1.944 billion in cash will be accretive for Cardinal within two years
Ambitious Plans for Sorin/Cyberonics Following Merger
Sorin and Cyberonics Inc. are to merge, creating a new entity that they expect will be a major player in its combined fields
U.S. Study of Smallest Pediatric Mechanical Heart Valve Starts
St. Jude Medical, Inc. has launched the HALO U.S. IDE Trial, designed to evaluate the safety and efficacy of the smallest pediatric mechanical heart valve in the world
Milestone for Biosensors as Japanese Arm of Drug Stent Trial Completes Enrollment
On paper, Biosensors’ BioFreedom Stent hits the sweet spot, featuring a proprietary anti-restenotic drug, yet without the need for polymer or other carrier. Studies will tell us more.
Japanese Regulatory Approval for Sorin’s MRI Compatible Pacing System
Sorin Group has gained Japanese regulatory approval for its new KORA 100 pacing system with automatic magnetic resonance imaging mode
Launch and First Implant of Boston Scientific’s Long-Lasting ICD
The new Extended Longevity ICDs, featuring EnduraLife battery technology promise almost twelve years
CE Mark for New Sizes of CoreValve® Evolut™R TAVI Offering
Now available in Europe in 26 mm and 29 mm sizes, Medtronic’s TAVI valves are delivered through a 14 French equivalent delivery system-the lowest profile on the market.
FDA Approves First Flexible-Tipped Cardiac Ablation Catheter
St. Jude’s FlexAbility is the first flexible tipped ablation device for the treatment of cardiac arrhythmias to gain U.S. approval
On-X® Life’s Chord-X™ Mitral Valve Chordal Repair System Launched at STS
It’s been the Society of Thoracic Surgeons Annual Meeting in San Diego for the last few days, an event that has seen On-X® Life Technologies Inc. unveiling its Chord-X™ Mitral Valve Chordal Repair System.
CE Mark and Launch for AliveCor AF Detection Function
AliveCor, Inc. has received CE Mark clearance for an automated atrial fibrillation detection function on its AliveCor® Heart Monitor.