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Home » FDA approves STJ’s MRI-safe SCS device | Regulatory news for the week of May 4, 2015

FDA approves STJ’s MRI-safe SCS device | Regulatory news for the week of May 4, 2015

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FDA approves MRI-safe SCS device from St. Jude Medical

April 30, 2015 by Brad Perriello

FDA approves MRI-safe SCS device from St. Jude Medical

St. Jude Medical said the FDA approved its Protégé MRI spinal cord stimulation device and Octrode percutaneous leads for treating chronic pain.

St. Paul, Minn.-based St. Jude said the Protégé MRI approval is for MRI scans of the head and extremities for patients implanted with the device, claiming it as the smallest MR-conditional SCS implantable pulse generator in the U.S. and the only device to offer software upgrades as an alternative to surgical device replacement. Read more

Surprise CE Mark for Stentys Xposition S stent

April 30, 2015 by Mark Hollmer

Surprise CE Mark for Stentys Xposition S stent

Stentys this week said it won a CE Mark ahead of schedule for its latest self-apposing coronary stent, a product that will be used with delivery system technology it acquired last June.

The early European regulatory O.K. enables Stentys to officially launch its Xposition S system at the EuroPCR conference May 19, the company said. Read more

Wright Medical delays Augment timeline

April 29, 2015 by Brad Perriello

Wright Medical delays Augment timeline

Wright Medical pushed back the timeline for FDA approval of its Augment bone putty, after the safety watchdog said last month that the vendor that makes Augment must undergo another site inspection.

In early February Memphis-based Wright said that an FDA inspection conducted as part of a review of Augment prompted a Form 483 warning to the vendor. Today Wright, in reporting its 1st-quarter earnings, said it asked the FDA to schedule the follow-up inspection on or after May 4. Read more

FTC: We might force M&A divestitures in outside markets

April 28, 2015 by Brad Perriello

FTC: We might force M&A divestitures beyond the market

The U.S. Federal Trade Commission last week said it may force companies to divest assets outside of the market the anti-monopoly bureau its trying to regulate.

The FTC and other international anti-trust regulators often requires companies to sell off assets that are similar to some of the assets being acquired in a merger, to reduce the chance of 1 company dominating a market. Read more

FDA closes out CryoLife warning letter, PerClot trial launches

April 28, 2015 by Brad Perriello

FDA closes out CryoLife warning letter, PerClot trial launches

CryoLife Inc. that the FDA closed out a warning letter from 2013 about problems at a plant in Kennesaw, Ga., after follow-up inspections last month found the issues corrected and no further violations.

The FDA’s website lists the close-out date as April 23 for the January 29, 2013, warning letter. Read more

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