By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical's Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...

Anyone who reads this blog on a regular basis knows I'm leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to give FDA the once-over once again, this time over the agency's omissions regarding social media. As readers of Medical Device Daily know, the Center for Devices and Radiological Health has proposed using social media for compliance and enforcement activities, which I covered in the Oct. 7 edition. I should...

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...

After Johnson & Johnson (J&J, New Brunswick, New Jersey) said that it was going to discontinue its work in the drug eluting stent (DES) market, my eyes then began to focus on Medtronic (Minneapolis), which has recently taken a beating in the wallet and court of public opinion with its bone growth product, Infuse. I began asking myself how much longer before Medtronic finally abandons ship on this application. I mean if there ever was a shining example of a device that has caused problems for a company then Infuse is it. The med-tech juggernaut was dealt what one would...

Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion. But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer...

  The title of this posting pretty much says it all, but I'm paid to tap out words on my keyboard. So here we go. Remember FDA's draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device's filing. So what's a device maker to do? Cite every potential predicate it can. Why? You have to ask? Yes, yes, FDA wants to cut down on the use of...

  As the saying goes, there are things we know we don't know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting. FDA to put brakes on surgeon training? FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor's training of doctors in...

In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully. FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance...

Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let's take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less than the average time needed to get a patent through the U.S. Patent and Trademark Office, which is another story. Aug. 12, 2009: Schultz out at CDRH; Shuren to serve as interim director On Aug. 11, 2009, the Internet was abuzz with reports that Dan Schultz, MD, had stepped...