Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced […]
Boston Scientific
First patients enrolled in trial for Boston Scientific’s SpaceOAR Vue hydrogel
GenesisCare announced today that it enrolled the first patients in a trial for Boston Scientific’s (NYSE:BSX) SpaceOAR Vue hydrogel. Boston Scientific’s SpaceOAR Vue hydrogel will be evaluated in the SABRE trial, sponsored by Boston Scientific, for prostate cancer patients receiving stereotactic body radiation therapy (SBRT). Get the full story at our sister site, MassDevice.
Boston Scientific touts data from Phase 3 study of selective internal radiation therapy
Boston Scientific (NYSE:BSX) today touted data from a Phase 3 clinical trial of its TheraSphere Y-90 glass microspheres treatment. In the trial, the TheraSphere treatment successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) in patients with metastatic colorectal cancer (mCRC) of the liver. Marlborough, Mass.-based Boston Scientific’s TheraSphere treatment, […]
Boston Scientific initiates coronary drug-coated balloon study in U.S.
Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]
Boston Scientific to expand its Maple Grove, Minn. campus
Boston Scientific (NYSE:BSX) is planning a fourth building at its Maple, Grove, Minn. campus to support expanded nitinol stent manufacturing. The Maple Grove Planning Commission is scheduled to review project plans tonight for the roughly 76,000 ft2 building. “This new building will allow for movement of some production currently taking place in existing buildings on that campus, […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]
Soligenix soars on COVID-19 vaccine licensing agreement with Boston Scientific
Soligenix (NSDQ:SNGX) skyrocketed up 89% in premarket trading this morning after announcing today that it entered into an exclusive worldwide licensing agreement with Boston Scientific (NYSE:BSX) for its CoVaccine HT novel vaccine adjuvant for COVID-19. Shares of SNGX were up 12.5% at $1.58 per share in mid-morning trading today as well. Boston Scientific’s BTG Specialty Pharmaceuticals […]
Study: High- and low-dose drug-coated balloons equally effective in PAD
A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
