The mood was pretty somber going into Heartware’s (Framingham, Mass.) breakout session during the 34th annual J.P.Morgan Healthcare conference. But why wouldn’t it be? It’s not everyday that a med-tech CEO has to discuss halting a European trial on one of its most promising technologies. But that’s exactly what Doug Godshall, Heartware president/CEO did. Godshall, who took the leadership position of Heartware in 2006, delivered the bad news across a sea of somewhat disenchanted faces during the conference. He did a great job, but honestly, is there ever a “good way” to deliver bad news? You see, Godshall revealed...

This week in med-tech history:  Nine years ago this week the biggest news in Medical Device Daily was Guidant’s recall of nearly 50,000 implantable defibrillators, coupled with the company’s failure to alert customers of the danger of one of the devices for nearly three years after it was aware of a problem. On June 21, 2005 MDD reported that the Guidant recall created a serious issue for Johnson & Johnson, which at that time was planning to buy Guidant for $25.4 billion. But of course when we fast forward a bit to January 2006, we know that deal never went...

America is the fattest country in the world. The obesity epidemic is one of the largest problems facing the healthcare system, both from a clinical and an economic perspective. Pardon the pun. The Centers for Disease Control and Prevention reports that more than one-third of U.S. adults (35.7%) are obese. Because obesity is associated with so many other health problems, such as heart disease and diabetes, the topic has drawn a great deal of attention at industry gatherings, including the Cleveland Clinic Medical Innovation Summit last month where the clinical focus was on obesity, diabetes, and the metabolic crisis. But...

Sooner or later, we’ll all know someone who has lost his or her life to heart disease, and today, Sept. 10, 2012, is the 20th anniversary of my father’s passing. George Edward McCarty had undergone a triple bypass several years earlier, but restenosis of the coronary arteries and an otherwise failing heart would be his undoing. The world of medical technology has changed enormously since Dad died, so much so that what we now take for granted might have seemed miraculous in 1992. Would Dad have lived another 20 years had his predicament arisen 20 years later in medical history?...

“Take it back!” “No, I won’t take it back, you stop bothering me!” “I said . . . take it back!” No, I didn’t hear this exchange at the playground in my neighborhood. Nor did this occur at the customer service counter of my local department store. But rather, this is the tone of a med-tech spat taking place in the “virtual” sandbox that has been taking place this week; one which has caught the attention of industry observers. St. Jude Medical (St. Paul, Minnesota) is miffed about a recent paper published in the journal Heart Rhythm written by...

At Medical Device Daily we’re usually fortunate enough to talk to a lot of the movers and shakers in the medical device industry. Company CEOs, doctors, researchers, and other industry leaders who are truly on the front lines of medical innovation are regular sources for our daily stories. But every once in a while we get to talk to someone who has had such a massive impact on this industry that it leaves us a little bit star struck to have the opportunity to speak with...

It’s hard to believe by looking at the 11.5” cultural icon, but Barbie is celebrating her 53rd birthday today. Perhaps her life in plastic is the reason she looks so great for her age but the Society for Vascular Surgery is putting a different spin on the doll’s birthday – noting that Barbie has always maintained an active lifestyle. The organization is using the milestone to highlight the importance of women’s vascular health issues. “Women in their 50s should remain active,” said Kellie Brown, MD, a member of the Society for Vascular Surgery. “Thirty minutes of exercise daily, eating healthy,...

The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...

It’s that time of year again when millions of us in the U.S. make New Year’s resolutions to improve ourselves in some grand way – often by means of getting in shape and/or leading an overall healthier lifestyle. And this year we’re sticking to it – right? Well, at least until mid-February. Fortunately this year there are dozens of free mobile health apps that can help us with our resolutions - or at least make it more fun trying.  There’s literally an app for everything from helping you lose weight to tracking your menstrual cycle, monitoring your heart rate, and...

“Okay, hon. I’m headed over to MammothMart. Need to grab some beer and munchies for the Monday night game, a replacement shower head for the bathroom and maybe that new Michael Connelly book." “I might as well get the oil change and lube done on your SUV while I’m there. And while I’m there, I’ll get that loose pair of glasses tightened at the optical shop. Oh yeah, and I guess I’ll have them check out that stomach pain I’ve been having off and on.” If any of the above seems to border on crossing the line between imagination and...