All Articles in: Boston Scientific

FDA Green Light for Boston Scientific’s New Defibrillators and Heart Failure DevicesApril 16, 2014

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices, including the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.

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FDA and CE Nods for Boston’s Expect™ Slimline (SL) Needle for Fine Needle Aspiration During Endoscopic UltrasoundApril 8, 2014

Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

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Boston Scientific’s TAVI Data Stands Up to Big TwoApril 3, 2014

While Edwards Lifesciences and Medtronic slugged it out at ACC 2014 with studies comparing their TAVI (transcatheter aortic valve implantation)offerings, Boston Scientific draws our attention to new data presented at the event that says its own Lotus™ Valve System continued to demonstrate impressive performance at three months.

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Registry Data Supports Boston Scientific S-ICD™ SystemApril 1, 2014

Boston Scientific points us at a new publication that details registry data relating to the real world performance of the company’s S-ICD (Subcutaneous Implantable Cardioverter/Defibrillator) and finds the device does the job.

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CE Mark Approval and First Implants of Boston Scientific’s Ingevity™ MRI Pacing LeadsMarch 14, 2014

Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.

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CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary StentMarch 13, 2014

Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation bare metal stent for the treatment of coronary artery disease (CAD). Background CAD, a narrowing of blood vessels that supply …

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Boston Scientific/Dystonia Europe/European Parkinson’s Disease Association PartnershipFebruary 26, 2014

Dystonia Europe and the European Parkinson’s Disease Association have announced that they are collaborate with Boston Scientific Corporation to increase awareness, understanding of solutions and to take initiatives in the worldwide fight against Parkinson’s disease and dystonia, two areas of high unmet need.

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CE Mark for Boston Scientific WallFlex™ Esophageal Stent for Refractory Benign Esophageal StricturesFebruary 17, 2014

Boston Scientific Corporation has received CE Mark approval for its WallFlex™ Esophageal Fully Covered Stent to treat refractory benign esophageal strictures.

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CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D SystemsDecember 17, 2013

Boston Scientific has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems and seen first implantations in Italy.

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Panel’s Yes Vote Means FDA Will Find it Hard to Say No to Boston’s WATCHMAN™ LAA Closure DeviceDecember 12, 2013

Could the FDA be about to approve a permanently indwelling, percutaneously inserted Left Atrial Appendage closure device? It’s hard to see the agency going against the 13:1 vote in favour from its expert panel.

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Boston Scientific Reports Impressive Pain Relief Results for Precision Spectra™ Spinal Cord StimulatorDecember 6, 2013

New retrospective data presented at NANS 2013 this week show highly significant reduction in pain and high trial therapy success rate of Boston Scientific’s Precision Spectra in the treatment of chronic pain

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FDA Approval for Boston’s Promus Premier™ “Next Generation” Drug StentNovember 25, 2013

Boston Scientific has followed its July CE mark approval of the Promus Premier drug eluting stent, with a newly announced FDA approval. The company claims “next generation” status, based on enhancements in stent design and delivery system.

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Boston Scientific’s Lotus™ TAVI Sees First Commercial Implants in EuropeNovember 20, 2013

Last month we noted the CE mark approval of Boston Scientific’s Lotus™ transcatheter heart valve, which was indicated for use in aortic valve patients for whom conventional surgery was a high risk option. Now the first two commercial implants of the Lotus Valve have taken place in a German hospital.

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US and EU Nods for Boston Scientific’s Direxion™ Torqueable Microcatheter

Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.

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All Eyes on Watchman FDA Panel Meeting in DecemberNovember 13, 2013

December 11th sees the FDA’s Circulatory System Devices Panel meet to discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage Closure Technology.

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“All Comers” Study Tests Medtronic’s Resolute Integrity vs Boston’s Promus ElementNovember 5, 2013

Medtronic is trumpeting quite a landmark with the publication of a first head-to-head randomized controlled trial of “third-generation” durable-polymer drug-eluting stents for the treatment of coronary artery disease in an “all-comers” patient population. Resolute Integrity’s greater longitudinal strength doesn’t seem to play out in better target vessel failure stats.

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