St. Jude Medical, Inc. has announced the first implant of its Portico™ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval.
Heart Valves
FDA Publishes Further Information Following Approval Of Edwards Sapien Valve
FDA has followed up its approval of Edwards’ Sapien Transcatheter Aortic Valve with information pertaining to the approval and use of the device.
More from TCT2011: Transfemoral, but not transapical TAVR, “economically attractive”
Researchers claim Transapical TAVR is “unattractive from a health economic perspective.” compared with femoral approach.
Transcatheter Cardiovascular Therapeutics conference 2011: Live link of UK case highlights FDA’s caution on Sapien Aortic Valve PMA.
Update from TCT2011 sourced from an article by Medical Device Daily
Despite Higher Sales, Atricure 3rd Quarter Loss Increased as Margins Decrease and Operational Costs Climb
Atricure’s Quarterly Earnings Report gives reason for optimism despite increased losses.
Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve
Already approved in Europe since March 2010, Edwards’ Sapien XT valve now gains further investigational device study arm in USA.
Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
Edwards Lifesciences gains first U.S. commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
SORIN Q3 RESULTS SHOW GROSS MARGINS ABOVE 60%
Sorin’s profits climbed by 47.5% year on year despite sales slowdown
Successful US implants of ValveXchange® two-part heart valve system: Eu trials planned
ValveXchange, Inc. has performed successful First In Man (FIM) surgeries demonstrating the practicality and advantages of its novel Vitality™ two-part heart valve system.
Study Finds Edwards Lifesciences’ Port Access System Facilitates Improved Outcomes Compared to Sternotomy
Edwards Lifesciences Corporation announced that new research demonstrates that using its minimally invasive PORT ACCESS System in mitral valve surgery significantly improves outcomes when compared to conventional sternotomy.
Medtronic’s CoreValve Shows Subclavian Access Success in Patients Contraindicated for Femoral Approach
Medtronic, Inc. announced new data presented today on the safety and effectiveness of Medtronic’s CoreValve system via a novel, subclavian approach.
Direct Flow Medical Completes First Human Use of 18F Percutaneous Aortic Valve System
Direct Flow Medical, Inc. a privately held, emerging medical device Company developing a next generation, minimally invasive implant to treat patients with heart valve disease announced today the first human use of their new 18 French Percutaneous Aortic Valve (PAV) System.
Edwards Lifesciences Reports Positive Data From Its Largest Transcatheter Valve Implant Series
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced at EuroPCR 2009 the results from its first post-market study of consecutively enrolled Edwards SAPIEN transcatheter aortic valve patients.