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...

By JIM STOMMEN, Medical Device Daily Contributing Writer  The arguments going on these days over the prostate cancer screening test known as prostate-specific antigen (PSA for short) might make one think that there’s something wrong with the test itself. Not so. The argument by what we will refer to as the “anti” side of the issue is with what happens after the routine blood test comes back with a positive finding. Those folks, who go by the name U.S. Preventive Services Task Force, maintain that the PSA test leads to demonstrative levels of over-treatment, doing so to such an extent...

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...

I went to see my doctor a few weeks ago for a physical. Since I just turned 40, he recommended that I have a CT scan to check for calcification in my heart valves. Maybe I would have said  "no," when he mentioned that the cost would not be covered by insurance, but his cautionary tale about a person he knew who had collapsed and died of a heart attack at the age of 42 persuaded me that maybe this was a good idea after all. I went in for the test yesterday and the entire procedure took less than...

  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...

The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up because Steve Grossman of the Alliance for a Stronger FDA (Washington) raised the issue recently at the Gooznews blog. So let's take a quick look at this issue and examine the question of not just whether FDA is sourced to do this, but whether it should even consider such a task. As for resources, this is a no-brainer. While the...

Frustration could not even begin to describe the look on my mother’s face during a recent trip to a local lab here in Atlanta to get some diagnostic tests run. The lab had lost all their electronic records, along with my mother’s, and they could not run a check of her blood in a timely fashion. This was a procedure they had no problem completing in 20 minutes, just three weeks prior. Apparently, it was some type of system outage and the lab was unable to recover all the data. They would gladly take her information again, but there were...

A prolific inventor who died last week in upstate New York at the age of 92, Wilson Greatbatch is credited with more than 325 patents, including coming up with the first practical implantable pacemaker. Besides being memorialized for those breakthroughs, he truly should be viewed as an inveterate tinkerer who as much as any single individual represents the very best of what that term means to medical innovation. While the invention of the...

We who scribble for a living find it easy to go off on those who do not, and today's bulls-eye is on the patent reform bill recently signed into law, the America Invents Act of 2011. One of the interesting things about H.R. 1249 is that it puts some of the fees collected by the U.S. Patent and Trademark Office in an escrow for Congress to decide whether to release to PTO. I've asked a number of people around Washington whether they think Congress can resist the temptation to write PTO an IOU and just keep the money, and almost...