Spectranetics Corporation today reported the first human procedures using its Turbo-Tandem™ System, which had earlier received FDA clearance and CE mark approval for marketing in the US and the EU.
Catheters
CardioFocus Receives CE Mark For Atrial Fibrillation Ablation Catheter
CardioFocus, Inc. announced that it has received a CE Mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation.
NeuroTherm Completes Acquisition of the Micron Epidural Catheter
NeuroTherm announces the acquisition of the Micron Catheter from private owners in Palm Beach Gardens, Florida on June 17, 2009.
St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump.
FDA Clears Boston Scientific’s SpyScope® Access and Delivery Catheter
Boston Scientific Corporation today announced that it has received FDA 510(k) clearance to market its SpyScope® Access and Delivery Catheter for diagnostic and therapeutic applications in the pancreatico-biliary system.
Invatec Officially Launches Coronary Drug-Eluting Balloon Platform IN.PACT™ Falcon At EuroPCR
Invatec, a comprehensive innovator of interventional products, today announced the availability of its newly CE marked coronary balloon, the IN.PACT™ Falcon paclitaxel-eluting PTCA balloon catheter at the EuroPCR Congress 2009 in Barcelona, Spain.
Endosense Unveils TOCCATA Trial Results: The First Complete Assessment Of Force In Catheter Ablation
Endosense has announced the release of acute clinical results from the TOCCATA (TOuCh+ for CATheter Ablation) European clinical trial at Heart Rhythm 2009, the Heart Rhythm Society’s 30th Annual Scientific Sessions in Boston, May 13 – 16.
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.
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.
Edwards Lifesciences Completes Enrollment in Non-Surgical Study Arm of U.S. Clinical Trial for Transcatheter Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial — known as the PARTNER Trial — for the Edwards SAPIEN transcatheter aortic heart valve.
Abbott Launches VOYAGER™ NC Coronary Balloon Catheter
VOYAGER™ NC Coronary Balloon Catheter is the latest Innovation in Balloon Technology, Designed to Optimize Treatment of Patients with Coronary Artery Disease