About a year ago, I wrote a story about the entrepreneurs who had created a potentially revolutionary new medical device that appeared to have the remarkable ability to lower blood pressure in patients where drug therapy didn’t help. Medtronic had bought the U.S. rights to the device, the so-called "Symplicity," for some $800 million—one of the highest amounts ever paid for a medical device.
The device was created by entrepreneurs Howard Levin and Mark Gelfand, who specialize in treating chronic diseases with devices inspired by long-abandoned surgical technicques. The Symplicity used a complex surgical technique known as "renal denervation," which at the time had shown extraordinary promise in small clinical trials. The American Heart Association was enormously excited about its prospects. The esteemed Cleveland Clinic named it the top innovation of the year in 2012. Meanwhile, a similar treatment was already gaining favor in Europe. All the lights, so to speak, were flashing green.
But the results of the Medtronic trial are in, and they’re shocking: in a large, rigorous, closely supervised clinical trial, the device failed to significantly lower blood pressure in patients with intractable hypertension. One group of patients was treated using Symplicity, and another was treated using a "sham" procedure, which is a control similar to that of a placebo in drug trials. The difference between the two groups was "paltry" and the six-month study found that the Symplicity procedure "had no significant effect" on ambulatory systolic blood pressure in the patients treated.
While it may be the case that renal denervation has a future utility in different kinds of patients—or perhaps with a differently designed device—for now this can only be interpreted as an innovation that wasn’t. It’s yet more proof of how rare, and how difficult, real breakthroughs can be, especially in the medical field. Meanwhile, for device inventors, it’s back to the drawing board.
We write a lot about innovation at Fast Company, but we also write a lot about how innovation involves a fair degree of risk. It’s hard to be an innovator, in other words, unless you take a leap that might end in failure. Sometimes the risks have to do with market acceptance. Maybe nobody likes your gadget or app, or maybe a competitor makes one better. But sometimes the risks come earlier in a product cycle, and have to do with the technology itself. In other words, however promising your product may look, it may not work very well—or work at all.
Read the original feature article: Meet The Tech Duo That's Revitalizing The Medical Device Industry
[Image: Flickr user Paul McCoubrie]