Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths (32mm and 38mm) of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, opening the door for the treatment of longer lesions.
Approval/Clearance
Boston Scientific Claims Its U.S. Defibrillators Enjoy Increased Longevity. FDA Agrees
The U.S. FDA has approved revised product labeling for the Boston Scientific Corporation INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices.
FDA 510(k) Clearance for ViewRay’s MRI-Guided Radiation Therapy System
Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.
FDA Clearance For Endoscopic Gastro-Oesophageal Reflux Disease Device
Israeli device company Medigus Ltd. has announced that it has received FDA 510(k) clearance for its SRS endoscopic system, designed for minimally-invasive endoluminal treatment of Gastro-oesophageal reflux disease.
FDA Clears Boston Scientific To Expand Indications For CRE™ Balloon To Include Into Stone Extraction
Boston Scientific Corporation has announced the FDA clearance for an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy, quite literally opening up the possibility of using it for dilation assisted stone removal.
Bioptigen’s Envisu™ Becomes First OCT System FDA Cleared For Hand-held Paediatric Ophthalmic Imaging
Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.
FDA Clears Winx™ Sleep Therapy System
This clever device from ApniCure Inc., gets around the need for a mask in treating sleep apnea, by employing a soft mouthpiece which together with a vacuum created by the device pulls the palate forward and stabilises the tongue. FDA agrees and has cleared the device under its 510(k) regulations.
CE Mark For Ekso Bionics “Exoskeleton” Enables Wheelchair Users To Stand And Walk
State of the art materials lie at the heart of this incredibly liberating exoskeleton for people with spinal cord injuries. The definition of a medical device, for CE mark purposes stretches from cranberry pills to exoskeletons it seems as Ekso Bionics announces gaining of clearance to market in Europe.
FDA Approval For Covalon’s IV Clear™ Antimicrobial Silicone Adhesive Film Dressing For Securing Vascular Access Medical Devices
Covalon’s IV Clear™ Silicone dressing is comfortable to wear and remove and contains two antimicrobial components within its adhesive layer, making it a compelling proposition in the market for securement of such as IV access devices. Now the product has FDA clearance to add to its Health Canada approval.
Clogging In The Past As Adherus™ AutoSpray Dural Sealant Gains CE Mark
Hydrogel sealants have a habit of clogging in their applicator nozzles, a problem Hyperbranch reckon they’ve solved with their newly CE marked Adherus™ Autospray device.
New EU Min Three-Month Anti-Platelet Indication A First For Abbott’s XIENCE PRIME™ and XIENCE V® Drug Eluting Stents
Dual anti-platelet therapy is normally required for 6-12 months after implantation of a stent, with associated risks, costs and general inconvenience. No wonder then that Abbott is sounding pleased with itself as it gains the first indication of its kind to reduce the therapeutic period to a minimum of 3 months based on data from 10,000 patients.
European Approval And Launch Of St.Jude’s EnligHTN™ Renal Denervation System
EuroPCR is being held in Paris right now and is the European focal point for all things cardiovascular. St. Jude Medical, Inc. has chosen the event to announce CE Mark Approval and launch of its EnligHTN™ renal denervation system.
CE Mark and EU Launch Of Boston Scientific’s Innova™ Self-expanding Bare-Metal Peripheral Vascular Stent
Boston Scientific Corporation has issued an announcement confirming CE Mark approval and European market launch of the Innova™ Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee.
FDA 510(k) Clearance for Maquet’s New Mega® Intra-Aortic Balloon Catheter Sizes
MAQUET Cardiovascular LLC has announced that it has received FDA 510(k) clearance for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater haemodynamic support, regardless of their height.
CE Mark For C-Cath® Intra-Myocardial Injection Catheter
Direct injection of stem cells and other biotherapeutics into the myocardium is quite a hot topic, so the announcement of an optimised injection catheter must be well timed.
FDA Approval And US Launch Of Sorin’s Portfolio Of Implantable Heart Device Leads
Following CE marking earlier this year, Heart Rhythm 2012 sees Sorin announce FDA approval and US launch of its new pacing, defibrillation and left ventricular leads.