All Articles in: Boston Scientific
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.
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.
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.
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.
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.
CE Mark for Boston Scientific’s Lotus™ TAVI SystemOctober 28, 2013
Boston Scientific’s Lotus™ Transcatheter Aortic Valve Implant has gained CE Mark approval as a treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.
Boston Scientific Wins Tech Award, But Plans Restructure LayoffsOctober 24, 2013
Boston Scientific is never far from the news and this week is no exception as the company gains a prestigious award for its recently acquired subcutaneous ICD technology. At the same time news was released that its ongoing restructuring plans are likely to result in up to 1500 job losses.
Boston Scientific Corporation has completed enrollment in the EVOLVE II randomized, controlled clinical trial of its SYNERGY™Stent System. The safety and efficacy study will support U.S. FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.
FDA Nod for Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter and Zurpaz™ 8.5F Steerable SheathAugust 21, 2013
Boston Scientific Corporation continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. The company says these products join its growing portfolio of next generation EP tools designed to redefine ablation technology.
Boston Scientific Completes Enrollment In SuperNOVA Trial Evaluating Innova™ Self-Expanding Stent SystemAugust 20, 2013
Boston Scientific has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of its Innova™ Self-expanding Stent System.
GSK, Boston and Covidien Keep Toes in Water as SetPoint Medical Secures $27 Million FinancingAugust 9, 2013
Biomedical technology company SetPoint Medical,developing neuromodulation therapies for inflammatory diseases, has secured $27 million in financing from its current investors along with new investors who’s names you might recognise.
Boston Scientific Launches Trial to Evaluate Neurostimulation for Treatment of Chronic MigraineJuly 22, 2013
Boston Scientific Corporation has launched a clinical trial to determine whether occipital nerve stimulation using the company’s Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications.
Italy’s Sorin Group has issued a press release in which it confirms it will be participating in the manufacture of Boston Scientific’s Lotus™ transcatheter heart valve. The news is seen as confirmation that the device will soon gain its first …
Boston Scientific Corporation has received U.S. FDA 510(k) clearance and CE Mark approval for the Guidezilla™ Guide Extension Catheter and has launched the device in the U.S. and Europe. The company says its Guidezilla device is designed to make complex …
Last month we covered the EU launch of Boston Scientific’s respiration-sensitive Vitalio™ pacemaker. Now the company has announced the first post-launch implantation of the device, which has taken place at a Dutch hospital.
C. R. Bard, Inc. has entered into an agreement to sell certain assets of its Electrophysiology division to Boston Scientific Corporation for $275 million in cash. The transaction is expected to close in 2013, subject to certain regulatory and customary closing conditions.
<< Previous Articles