JenaValve isn’t yet a household name in transcatheter aortic valve circles, but its new Chief Tech officer might just see that change.
Cardio
FDA Approval for Medtronic Attain Performa® Quadripolar Lead and Viva® Quad CRT-Ds
Medtronic’s new Performa® Quadripolar Lead and Viva® Quad CRT-Ds claims optimal and efficient Cardiac Resynchronization Therapy
Start of Thoratec’s HeartMate PHP™ CE Mark Trial is Silver Lining After Poor Q2
Thoratec Corporation, has announced the start of its CE Mark Clinical Trial for HeartMate Percutaneous Heart Pump.
FDA Approves SynCardia’s Total Artificial Heart With SynHall Valves
FDA approval for SynCardia temporary Total Artificial Heart with SynHall valves, gives the company control over the last key component to manufacture the Total Artificial Heart.
EXCOR® Pediatric Ventricular Assist Device Study Completes Enrollment
Berlin Heart’s Humanitarian Device Exemption for its Excor Pediatric VAD was conditional on undertaking a post-approval study. Now enrollment is complete and most patients have reached endpoint date.
CE Mark for Boston Scientific’s Agent™ Drug-Coated Coronary Balloon
Boston Scientific’s Agent™ Paclitaxel-Coated PTCA Balloon Catheter has gained CE mark approval and will now be launched in Europe.
FDA Approves Sorin’s Solo Smart™, First Stentless Fully Biological Valve
Italian cardiovascular device maker Sorin Group, has gained U.S. FDA approval for the Solo Smart™ Aortic Pericardial Heart Valve which the company claims is the first biological valve to feature a fully removable stent.
Healthy Sapien Sales for Edwards. Not to Mention that Other $750 Million
Take out the $750 million settlement from Medtronic and Edwards would still be happy with a healthy sales increase over the equivalent quarter a year ago.
Perky Sales for AtriCure But Margin Down and Expenses Up Means Losses Increase
Atrial Fibrillation specialist AtriCure, Inc. has announced financial results for the second quarter of 2014.
Sorin’s Phospholipid-Reducing Crown Valve Gains CE Mark
Cardiovascular device specialist Sorin Group, has gained CE mark certification for its innovative CROWN PRT™ stented aortic bioprosthesis.
CE Mark and First Use of St. Jude’s FlexAbility™ Ablation Catheter
St. Jude Medical, Inc. has gained CE Mark approval and announced first use of the FlexAbility™ Ablation Catheter, a novel ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias.
FDA Approves Boston Scientific’s REBEL™ Coronary Stent
U.S. FDA approval of REBEL™ Platinum Chromium Coronary Stent brings the benefits of modern stent architecture to patients not suitable for drug eluting variants.
Boston Scientific Plugs TAVI Gap with CE Mark for 25 mm Lotus™
Boston Scientific’s Lotus™ TAVI System has been enhanced by the addition of a 25mm variant to its CE marked portfolio.
Severe Mitral Regurgitation Patients Benefit from MitraClip too.
Registry data suggests that use of MitraClip to reduce mitral valve regurgitation confers benefits in even severely ill patients.
Problem Solved, Cook Reintroduces Evolution® RL Lead Extraction Devices
Cook Medical is to recommence distribution in the United States of its Evolution® RL and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Sets following a two month suspension.
FDA Approves Studies into Cooling of Heart Attack and Stroke Patients
The U.S. FDA has approved two investigational device exemptions (IDE’s) to study the use of the Life Recovery Systems ThermoSuit® in the treatment of heart attack and ischemic stroke.