FDA has provided useful information on the recently approved Promus Element™ Plus drug eluting stent family of products from Bostons Scientific.
Boston Scientific
Boston Scientific And Cameron Health Acquisition Deal Closed
Boston Scientific has finalised its acquisition of Cameron Health and in so doing adds the first and only commercially available subcutaneous “leadless” ICD technology to its portfolio.
FDA Approves Longer Lengths Of PROMUS Element Plus Stent
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.
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 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.
PLATINUM Study: PROMUS Element™ Stent Demonstrates Impressive Long Term results In Small Vessels
Boston Scientific Corporation took the opportunity presented by EuroPCR to announce “excellent” two-year results from the PLATINUM Small Vessel study.
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.
World’s First Subcutaneous Implantable Defibrillator Gets FDA Panel Vote
Champagne corks will be popping at Cameron Health as FDA’s expert panel review results in a vote in favour of its subcutaneously implanted S-ICD® device. FDA approval is expected to follow within 12 months.
Sweaty Palms At Cameron Health Today?
April 26th is FDA Circulatory Panel decision day for Cameron Health’s S-ICD device. Not much resting on it… only $150m.
CE Mark For Boston’s Low Profile Emerge™ PTCA Catheter
Boston Scientific is having a good week, not least with the news that its super fine Emerge PTCA balloon catheter has gained its CE Mark.
Boston’s Lotus™ TAVR Offering Completes Trial Enrollment
Regulatory approval is one step closer with Boston Scientific’s announcement that its REPRISE I Clinical trial of the Lotus TAVR system has completed enrollment.
CE Mark For Boston Scientific’s New Pacemakers
Boston Scientific has trumpeted the CE mark approval of its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers.
U.S. Launch of Boston Scientific’s Z Flex-270™ Steerable Ablation Catheter Sheath
Boston Scientific has announced the immediate launch of its new Z Flex-270 steerable sheath to enable Cardiologists to precisely steer ablation catheters of up to 12F to target tissue.
New Backstop® Gel Stops Stone Migration In Urologic Procedures
Pluromed’s Rapid Transition Polymer™ technology finds another home in the prevention of stone migration during lithotripsy for urinary stone removal. Boston Scientific is worldwide distributor for the company’s Backstop® product.
Everolimus Shines As Meta-Analysis Suggests Lower Thrombosis Rates Than Others
Everolimus stents appear top dog in long term stent thrombosis meta-analysis.
Canada Approves Medtronic’s DBS For Epilepsy And Boston’s Cardiac Ablation System
Two new device approvals announced for Canada this week. Neither Medtronic’s DBS therapies for epilepsy nor Boston Scientific’s RF ablation catheter are US FDA approved, but Health Canada are clearly convinced by the weight of the submissions.