So far I’ve chronicled my visit to Canada by focusing on what I’ve learned so far about the country’s focused efforts on growing its medical device industry – which is, of course, the primary purpose of the Advanced Medical Devices Media Tour, organized by the Ontario Ministry of Economic Development and Innovation (MEDI). But in addition...

I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

Medtronic has the potential to be a trend setter with its attempt to have drug eluting stents (DES) treat erectile dysfunction (ED). The device maker recently moved one step closer in this effort as it reported that it had completed its ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors), feasibility study. The device, which hasn't been named yet, will be inserted into the pelvic area of the body. More specifically the stent is delivered using a catheter threaded up to the pelvis, where the pudendal artery is located. It...

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...

As a member of the trade press, I get a kick out of how routinely some people in the mainstream media and the population at large routinely assume that device makers are driven by greed and that doctors are morally flawless creatures who spend all their spare time pondering the public weal and woe, continuously devising ways to ensure their passage through the Pearly Gates with constant acts of selflessness. And then I see the parties weighing in on the question of Medicare coverage for the Sapien aortic valve made by...

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...

Back in the early days of Medical Device Daily – in fact, it might even have been in the relatively brief very early period of time when the new publication was known as Medical Device Week – it’s likely that few if any healthcare-related companies got more frequent mention in our pages than MedCath. Thinking back on that time, it seems like news stories on the high-flying operator of heart-focused specialty hospitals were appearing in MDW and then MDD with amazing regularity. It was “MedCath reported this week plans to open a new hospital in . . .” or “MedCath...

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...

There's nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off. If you work for a firm intent on bringing a PMA device to market, FDA's insistence on a 1,000-patient post-approval study (PAS) for the Sapien transcatheter valve might have given you a bad case of deja vu because a small firm might not be able to get investors on board, even...

A few weeks ago, I made the mistake of going into the gym around 6 p.m. That's the time when all the body builders and athletes tend to circulate in the area. I also made the mistake of getting on the treadmill next to someone who obviously looks like he runs track for a living. After seeing him run close to 10 mph without breaking a sweat - and I was struggling to do six -  I left the gym dejected. The competition in there was just too great. How could I possibly keep up with someone who can do a mile...