FDA Green Light for Boston Scientific’s New Defibrillators and Heart Failure Devices

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.

FDA and CE Nods for Boston’s Expect™ Slimline (SL) Needle for Fine Needle Aspiration During Endoscopic Ultrasound

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.

Boston Scientific’s TAVI Data Stands Up to Big Two

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.

CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent

Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”

Boston Scientific/Dystonia Europe/European Parkinson’s Disease Association Partnership

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.

Panel’s Yes Vote Means FDA Will Find it Hard to Say No to Boston’s WATCHMAN™ LAA Closure Device

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.

Boston Scientific Reports Impressive Pain Relief Results for Precision Spectra™ Spinal Cord Stimulator

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

FDA Approval for Boston’s Promus Premier™ “Next Generation” Drug Stent

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.

Boston Scientific’s Lotus™ TAVI Sees First Commercial Implants in Europe

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.

“All Comers” Study Tests Medtronic’s Resolute Integrity vs Boston’s Promus Element

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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