Forbes is not exactly a medtech publication. It’s fascinating therefore to see it covering the story of how an investigator … continue reading “FDA Warning For CoreValve Investigator Hits The News”
Cardio
CE Mark For Medtronic’s Engager Transcatheter Valve, Based On Positive Clinical Study Outcomes
Transcatheter heart valves hit our news pages seemingly every week. Today its the turn of Medtronic with the news that its Engager valve, optimised for transapical delivery, has gained CE mark approval, based on solid looking numbers from its pivotal multi-center study.
CE Mark For Claret Medical’s Montage 2™ Embolic Protection Filter
Claret Medical has gained CE mark approval for its Montage 2™ which becomes the only approved filter system protecting the carotid arteries capturing embolic debris during intravascular procedures such as Transcatheter Aortic Valve Repair.
Medtronic Gains First FDA Approval Under New Early Feasibility Study Rules
Medtronic’s new Transcatheter pulmonary valve study, approved by the FDA, represents the first time this new draft guidance has been employed. The result should be a better product, earlier to market, if the klegislation is doing its job.
FDA Clears New Sizes Of Resolute Integrity Coronary Stent For Long Lesions Common Among Diabetes Patients
Medtronic, Inc. has announced that the U.S. FDA has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm. The longer lengths include an indication for patients with diabetes in whom longer lesions are common.
FDA Approves First Single-Lead ICD with Atrial Sensing
Biotronik has announced the FDA approval of its Lumax 740 DX System. This novel device is a first-in-class implantable cardiac defibrillator (ICD) that utilizes a single lead with atrial sensing capabilities.
Patent Portfolio Growing For Direct Flow Medical’s Innovative TAVI System
Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, has announced it has been awarded two new patents for its clever TAVI system. One in Japan, one in U.S.
Ventrix’s VentriGel™ Demonstrates Potential to Prevent Heart Failure Following Heart Attack
Ventrix, Inc. announced today that its VentriGel™ cardiac repair scaffold safely and effectively mitigated left ventricular remodeling and improved cardiac function in pigs after myocardial infarction. The findings, made during pre-clinical studies, have been published in the journal Science Translational Medicine.
OrbusNeich Alleges Boston Scientific Infringes Some Of Its EU Stent Patents
OrbusNeich alleges that Boston Scientific has infringed two European patents covering certain novel stent designs. It claims two patents are infringed by several of Boston Scientific’s coronary stent systems, including the “PROMUS Element™”, “PROMUS Element™ Plus”, “OMEGA™ PtCr”, and “TAXUS™ Element™”.
Small, MRI Compatible And With Remote Monitoring: What’s Not To Like About Biotronik’s Newly CE Marked Ilesto 7 ICD/CRT-D Devices?
Biotronik has announced that its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE approval. The device family includes the one of the world’s smallest ICDs and is MRI compatible as well as being equipped with Biotronik Home Monitoring® technology.
New St.Jude Study To Explore Effects Of Renal Denervation On The Heart
“Super therapy” renal denervation may favourably impact major cardiac events and a new study hopes to demonstrate to what extent. We’ll be fascinated to see the results and are betting the house on the fact that there is a positive effect.
FDA Nod For Medtronic’s New MRI-Friendly Pacing System
Medtronic has gained FDA approval and will commence U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The system is Medtronic’s second-generation MR-Conditional pacemaker and is the first to combine the most advanced pacing technology with proven MRI access.
FDA Class I Recall For St. Jude’s Amplatzer™ TorqVue FX Delivery System
St.Jude’s Amplatzer PFO device has its own dedicated delivery system, called Amplatzer “TorqVue”. It seems there is a problem with the core wire on certain batches, all of which are now subject to an FDA class I recall.
CE Mark For Boston’s Promus PREMIER™ Everolimus-Eluting Platinum Chromium Stent System
Boston Scientific Corporation has received CE Mark approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, the company’s next-generation durable polymer drug-eluting stent technology.
Saphena Medical’s Next Generation Endoscopic Vessel Harvesting Device
Massachussetts medtech companies Pavilion Medical Innovations L.L.C. and STD Med, Inc. are jointly forming a new entity, Saphena Medical, Inc. Saphena will progress its platform Endoscopic Vein Harvesting technologies, its OnePass™ system achieving single-step, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
New Report Claims To Know What Renal Denervation Market Will Look Like In 2021
Does anyone inside the industry really know what the future holds for Renal Denervation? It’s a technology that is just at the starting line and very much entering shake-out phase. We’ve no idea what the market will look like in 2021, but this new report promises crystal ball properties.