Medtronic announces CE mark for CoreValve® Evolut™, incorporating features designed for optimal fit. With the new 23mm iteration, Medtronic claims its CoreValve family treats the broadest range of patient valve sizes.
Cardio
International Coronary Artery Disease Patients Have Access To Abbott’s Absorb™ Bioresorbable Vascular Scaffold
Abbott says the potential long-term benefits of a scaffold that dissolves are significant and include a return of vessel function. CE mark and approval in many other countries sees availability widen for this first-in-class solution.
First-in-Man Trials Point To Promising Performance From Novel Drug-Coated Balloon
German cardiology company Cardionovum GmbH has trumpeted results from a soon-to-be published preclinical and first-in-man clinical study of its Primus Drug-Coated Balloon (DCB). Clinical study results point to high procedural efficacy and no adverse clinical events out to six months.
CE Mark For Medtronic’s New Oxygenation System
Medtronic, Inc. has announced CE Mark for its new Affinity Fusion® oxygenation system, opening the door to a European launch. The system, which oxygenates and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for claimed patient safety and ease of use.
Boston Scientific Launches New ICD Lead In Europe And Asia
Reliance® 4-Front™ Lead is designed to streamline surgical procedure for implantation of ICDs by improving handling and simplifying implantation.
Boston Scientific Sees BridgePoint Medical’s Occlusion Crossing Systems Fitting Nicely
Boston Scientific Corporation is to acquire BridgePoint Medical, Inc., developer of a proprietary, catheter-based system to treat coronary chronic total occlusions.
Sorin’s Perceval™ S Bio Valve CE Indication Extended To Over 65’s
Sorin has announced CE Mark approval for extended indications of the Perceval™ S sutureless valve, expanding the market and, the company says, paving the way for adoption of Minimally Invasive Cardiac Surgery
FDA Clears Thoracic-Length Aptus HeliFX™ Aortic Securement System
EVAR specialist Aptus Endosystems, Inc., has received 510(k) clearance from the U.S. FDA for its thoracic-length HeliFX™ Aortic Securement System.
Transcath Mitral Valve A Step Closer As Neovasc’s Tiara™ Performs Well In Acute Preclinical Study
It’s an understatement to say that mitral valve replacement is a tricky business, so it’s unsurprising to see Neovasc trumpeting early successes in an about-to-be published preclinical study.
Heartwarming Development From Omaha Cardiac Surgeon
Congenital heart surgeon James Hammel, M.D., on Thursday presented a video demonstration of a novel infant cardiac surgical technique at the joint meeting of the Congenital Heart Surgeons’ Society and the European Congenital Heart Surgeons Association in Chicago. The technique allows many complex heart defect repairs, including the Norwood operation for hypoplastic left heart syndrome, to be performed more quickly and safely.
Pacemaker Donor Card Update
In a strikingly heartwarming example of humanity charities already exist to coordinate the distribution of usable, explanted pacemakers from deceased Americans to less fortunate people in the developing world. A new study suggests this is a safe and viable practice, although the manufacturers disagree, citing concerns over reprocessing practices.
Renal Denervation Gets The Healthcare Economic Nod
Medtronic, Inc. has announced findings from a health-economic analysis published online before print in The Journal of the American College of Cardiology that suggest the company’s Symplicity™ renal denervation system is a cost-effective treatment strategy for patients with treatment-resistant hypertension.
FDA Approves AF Ablation Device, But Not Yet For Use As An AF Ablation Device
Estech’s breakthrough technology for the first time combines the benefits of a bipolar clamp with the flexibility of an endoscopically guided probe with the capability of creating linear lesions anywhere on a beating heart. It’s for investigational use in AF ablation treatment in U.S right now.
Biodegradable Metal? But (Hopefully) Not Like My First Car
Combine the strength of steel with the absorption characteristics of a polymer like PLLA and you may have a new category of implant material. So hopes Bio DG which has just been granted a patent in the area.
Preventice receives FDA clearance to market BodyGuardian Remote Monitoring System™
Preventice™, Inc., a leading developer of mobile health applications and remote monitoring systems, announced today that the U.S. FDA has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System.
FDA Approves Abiomed’s Higher Flow Impella®
Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min