Medtronic, Inc. has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.
Cardio
Symplicity™ HTN-3 Renal Denervation Study Enrollment Complete
Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.
Five Year Data For Axxess™ Self-Expanding Bifurcation DES
New long-term data from the DIVERGE study, presented at this week’s EuroPCR 2013 congress has shown that the use of … continue reading “Five Year Data For Axxess™ Self-Expanding Bifurcation DES”
Could New BioMatrix™ DES 5000 Patient Registry Data Result In Shorter DAPT Course?
Stent maker Biosensors, tells us that new registry data presented this week at EuroPCR 2013 has confirmed that the BioMatrix™ … continue reading “Could New BioMatrix™ DES 5000 Patient Registry Data Result In Shorter DAPT Course?”
99% Freedom From All-Cause Mortality At 30 Days Says Direct Flow Medical TAVI Trial
This week’s EuroPCR event saw the publication of a study in which patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System. The DISCOVER Trial full 30-day outcomes suggested minimal post-procedural aortic regurgitation and adverse events.
St.Jude Medical Kicks Off EnligHTNment Study At EuroPCR
St. Jude Medical, Inc. has taken the opportunity presented by EuroPCR in Paris this week, to announce the start of … continue reading “St.Jude Medical Kicks Off EnligHTNment Study At EuroPCR”
CE Mark For World’s Longest Coronary Drug Eluting Stent
The newly CE marked XIENCE Xpedition™ 48 coronary stent leverages the well established design and clinical outcomes of the XIENCE Family of Drug Eluting Stents. A longer stent, compared with multiple short stents has the potential to reduce overall procedural costs, particularly in very long lesions most often seen in patients with diabetes.
Study Suggests Genous “Pro-Healing” Stent Lowers Stenosis Rate vs Bare Metal
Results of Randomized JACK-EPC Trial Published in Minerva Cardioangiologica suggest that the antibody coating on OrbusNeich’s Genous stent may be doing its job and attracting endothelial progenitor cells, thereby accelerating stent “healing”.
FDA Approves Thoratec’s HeartMate II® Pocket Controller™
Thoratec Corporation has received approval from the U.S. FDA to market the HeartMate II® Pocket Controller™, a device it calls the small, smart, safe face of the HeartMate II LVAD System.
CE Mark For Next-Generation Tryton Side Branch SHORT Stent
Tryton Medical, Inc., specialist in stents designed to treat bifurcation lesions, has gained CE Mark approval for its Tryton Side … continue reading “CE Mark For Next-Generation Tryton Side Branch SHORT Stent”
CE Mark For Biosensors New BioMatrix NeoFlex™ Drug-Eluting Stent
Biosensors International says its newly CE Marked BioMatrix NeoFlex™ drug-eluting stent builds on the strengths of its predecessor, but with enhanced pusability, trackability and crossability..
InspireMD to Announce Six-Month Results from the MGuard™ Embolic Protection Stent (EPS) MASTER Trial at EuroPCR
Embolic protection stent developer, InspireMD, Inc. has announced a robust schedule of educational events and data presentations at next week’s EuroPCR (May 21-24 Paris), culminating in the first presentation of 6-month results from the MASTER (MGuardfor Acute STElevation Reperfusion) trial of the Company’s MGuard™ Embolic Protection Stent
Valtech Cardio Treats First Mitral Regurgitation Patients with Percutaneous Annuloplasty Device Without Open-Heart Surgery
Valtech Cardio Ltd., a medical device company that develops solutions for mitral valve repair and replacement, announced today that two patients diagnosed with severe mitral regurgitation have been treated successfully with the Transfemoral Cardioband™ Annuloplasty System
IDE Study Green Light For Direct Flow’s Transcatheter Aortic Valve
Direct Flow Medical Inc. has received FDA approval for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of its novel transcatheter aortic valve system. We’ll be watching to see whether this study replicates EU study results showing a reduction in valve regurgitation.
St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement
With EuroPCR* taking place any day, now seems a good time for companies to be previewing their offerings and debuting … continue reading “St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement”
CE Mark For Elixir’s Bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System
Elixir Medical Corporation has received CE Mark approval for its DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to degrade in about one year returning the patients’ coronary vessel ultimately to its normal de novo state.