St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of the Promote® Plus cardiac resynchronization therapy defibrillator and Current® Plus implantable cardioverter defibrillators.
Cardio
Edwards Lifesciences Receives FDA Approval for New Heart Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.
Endosense Receives CE Mark for TactiCath Force-Sensing Ablation Catheter
Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has announced that it has received the CE mark for its TactiCath system.
St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair
St. Jude Medical, Inc. today announced the U.S. launch of its Attune Flexible Adjustable Annuloplasty Ring for the repair of diseased heart valves.
FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices
Medtronic, Inc. today announced U.S. Food and Drug Administration approval and availability of the Attain Ability® left-heart lead (Model 4196) for use with cardiac resynchronization therapy devices for heart failure patients.
SCAI Highlights Cardiac Dimensions Inc AMADEUS Study as an Important “Late Breaking” Clinical Trial
The Society of Cardiovascular Angiography and Interventions will highlight Cardiac Dimensions®, Inc.’s AMADEUS study during its 32nd annual scientific sessions held in Las Vegas, NV later this week.
Gore Announces Availability of Larger Diameter, Small Profile GORE EXCLUDER AAA Endoprosthesis
W. L. Gore & Associates today announced the May 4, 2009 availability of a 31 mm diameter version of the GORE EXCLUDER® AAA Endoprosthesis. The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms in patients with aortic inner neck diameters up to 29 mm.
St. Jude Medical Announces CE Mark Approval of Remote Care System for Implantable Cardiac Devices
St. Jude Medical, Inc. today announced European CE Mark approval of its Merlin.net™ Patient Care Network. Merlin.net PCN is a secure, Internet-based remote care system that gathers and stores data from the implant procedure, a clinic follow-up visit or from remote follow-up transmissions of patients with implanted cardiac devices.
Bolton Medical Obtains CE Mark for the New RELAY Plus Thoracic Stent-Graft Delivery System
At the recent Charing Cross Symposium in London, Bolton Medical announced the launch of a new and further improved delivery system: RELAY Plus.
Minnow Medical Receives CE Mark For Guided Re-Shaping Catheter To Treat Peripheral Artery Disease
Minnow Medical, a developer of innovative products to treat artery disease, announced it has received the CE Mark clearing its disposable catheter for marketing in the European Union.
Transoma Medical Announces First Patient Enrollment in Clinical Study on Atrial Fibrillation
Transoma Medical, Inc. announced the first enrollment and implant in a long-term study to monitor patients who have suffered a cryptogenic stroke (of unknown origin) to determine if atrial fibrillation is present.
NMT Medical Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant
NMT Medical, Inc. today announced that it received Pre-Market Approval from the U.S. Food and Drug Administration enabling commercial sale of the Company’s STARFlex® cardiac septal repair implant in the United States for patients with ventricular septal defects.
Medtronic Completes Acquisition of CoreValve Inc.
In a move to further expand a comprehensive cardiovascular portfolio, Medtronic, Inc. announced today the completion of its acquisition of CoreValve Inc.
Medtronic Initiates Global Abdominal Aortic Aneurysm Study
Medtronic, Inc. today announced the start of ENGAGE¹, the largest ever study of its kind, which will evaluate the performance of the Endurant stent graft, an implantable medical device designed to provide an advanced minimally-invasive alternative to open surgical repair of abdominal aortic aneurysms.
Berlin Heart Receives First Regulatory Approval In North America
Berlin Heart GmbH announced it has received its first marketing approval in North America, for the EXCOR® Pediatric ventricular assist device.
Cardima Receives CE Mark Approval for its Surgical Ablation Probe with Stabilization Sheath
Cardima, Inc., a medical device company focused on the treatment of atrial fibrillation and manufacturer of the Cardima Surgical Ablation System, today announced that it has received CE Mark approval for its Surgical Ablation Probe with Stabilization Sheath.