Boston Scientific Corp.’s (NYSE:BSX) Promus Element drug-eluting stent for small vessels won a nod from the FDA and BSX earned a ratings upgrade from investment bank Goldman Sachs.
The Natick, Mass.-based medical device maker said FDA regulators approved its Promus everolimus-eluting coronary stent for use in vessels as small as 2.25mm in diameter. The company said it plans to immediately launch the product in the U.S.
Earlier this year, BSX announced positive two-year results from a five-year study of its Promus stent and watched its stock slip.
This time Goldman Sachs upgraded BSX stock from "sell" to "neutral" and raised its price target from $6.50 to $7.00. The bank said it no longer sees "material downside to consensus estimates."
The company also touted positive findings for Promus at the EuroPCR conference earlier this month.
Stryker touts FDA clearance for ShapeMatch knee surgery guidance system
Stryker Corp. (NYSE: SYK) won 510(k) clearance for its ShapeMatch Cutting Guides, which use three-dimensional imaging data to develop a surgical plan for customized knee replacement. The ShapeMatch device is cleared for use with Stryker’s Triathlon Total Knee System.
BioMerieux wins FDA clearance for MRSA test
BioMerieux Inc. (EPA:BIM) landed 510(k) clearance for NucliSENS EasyQ MRSA, its automated molecular test that detects seven types of methicillin-resistant staphylococcus. The company says EasyQ can process up to 46 tests in three hours, as opposed to three days for conventional culture-based testing. The EasyQ MRSA test is offered through bioMerieux’s chromID test, which received FDA clearance in 2009. The latest win is welcome news for bioMerieux, which underwent a voluntary worldwide recall for one of its tests in April.
Boston Scientific had more good news this week with the announcement of CE Mark approval in the European Union for its Clik Anchor, a lead designed to work with the Precision Plus peripheral nerve stimulation device. Neurostimulation, also called spinal cord stimulation, can help manage chronic pain that results from failed back surgeries. The Clik Anchor features a locking system designed to improve lead anchoring and consistency. The device won FDA clearance in March.