On a February afternoon at New York-Presbyterian Hospital in northern Manhattan, the operating room has been filling for half an hour with a steady trickle of surgeons, anesthesiologists, nurses, medical researchers, and a few curious observers.
Some are here to help, others to witness something they have never seen before. The patient is heavily sedated but still awake; an LED screen suspended above the operating table displays the vital signs. Normal blood pressure is anything below 120 over 80. This patient's reading is 270 over 110. The astronomical numbers are why everyone has come today--to see whether chronic hypertension that drugs aren't helping will respond to a radical new procedure.
Ajay Kirtane, an interventional cardiologist and head of the surgical team, begins with a small incision near the patient's groin. He inserts a short, hollow sheath, his gloved hands speckling with blood. He then methodically threads a catheter--a long plastic tube--into the artery and, guided by a scan on an overhead display, to the blood vessels leading to the kidneys, which on the screen resemble giant gray beans. So far the procedure is a lot like any catheterization--complex yet utterly routine. The team pauses, however, while an assistant opens a 4-foot-long orange and white cardboard box marked with the word "symplicity" and removes what looks like a motorcycle throttle with an electrical cord at one end and a 3-foot-long wire on the other. He plugs the electrical cord into a generator and Kirtane threads the wire through the catheter till it reaches the kidneys. The assistant activates the generator. The patient doesn't flinch as an energy burst destroys a swath of the renal nerves. For the next 20 minutes, Kirtane manipulates the wire, wiping out various sets of nerves. Toward the end, he turns around and says, modestly, "That's all there is to it."
But in truth there is much more to it than that.
In the spring of 2003, Howard Levin and Mark Gelfand were just a couple of frustrated entrepreneurs banging around Silicon Valley, looking to sell a stake in an idea for the device that would become Symplicity. Over and over again, they made the rounds of the venture capital firms on Sand Hill Road, where they gave earnest but futile presentations to potential funders. With each passing month, they became more demoralized. Some VCs dismissed their idea as stupid, or crazy. Some thought it intriguing but too risky. All had a reason to say no. Gelfand recalls, "Everyone and their grandmother pissed on us."
They had expected a better reception. By the time they arrived in the Valley, the two men had already collaborated on several devices and had created several startups that either succeeded modestly or appeared to have real promise. One was a vest that could administer CPR to a patient in cardiac distress by automatically contracting and expanding; another was a blood-filtration device that alleviated symptoms of congestive heart failure. What's more, the potential pool of patients for their newest idea could be in the tens of millions. But you could see why the VCs had their doubts. For starters, the men didn't fit the Silicon Valley mold. Both were in their forties, well past the bloom of technological youth, and both were voluble New Yorkers. More to the point, their approach to medical innovation could kindly be described as audacious. They were pitching not just a new kind of machine but an entirely new kind of therapeutic treatment. In fact, their claims were tantamount to suggesting that rather than looking for the next miracle pill, the health care industry should be looking for the next miracle device. This stance cast them against the currents of medicine for the past half century. In an era when Big Pharma was spending billions on breakthrough products and patients would much rather take a pill than suffer a doctor's scalpel, why fund a device that sounded like a science experiment?
In the end, only one group of West Coast techies--a Menlo Park medical-device incubator known as the Foundry--was willing to bet on Levin and Gelfand's invention. Foundry CEO Hanson Gifford was intrigued by their research showing a relationship between the removal of renal nerves and improvements in cardiovascular health. In 2004, in exchange for a significant share of future profits, Gifford and his partners agreed to take over development of the project and set out to build, improve, and test a renal device. By 2007, the first human trials were starting to show that in some cases the new treatment might lower blood pressure far more than any single drug therapy could--and with few significant side effects. And these findings were the main reason Medtronic, the medical-device maker, bought the idea, now known as renal denervation, in 2011 for $800 million. It was the highest price ever paid for an early-stage medical-device technology.
At the moment, the treatment is being used in Europe on patients with drug-resistant hypertension and is in the midst of a large (and likely definitive) U.S. trial that includes New York-Presbyterian. Medtronic expects it to be on the market here within two years. Dr. Oz has already begun to blog about it. Until the trials are complete, the device elicits a wait-and-see caveat from most doctors. But in the half-dozen conversations I had with some of the country's leading cardiologists, a strain of barely contained excitement comes through, mainly because the preliminary results of the treatment are so astonishing, and the side effects so minimal, compared to new drug therapies. "You now have a technology that can potentially be done safely and reduce the blood pressure by 30, 40, 50 millimeters of mercury?" Mehdi Shishehbor, a cardiologist at the Cleveland Clinic, tells me. "That is just enormous."
Levin admits, only half-seriously: "We are now the most famous people you've never heard of." But then he adds, "People come to us and say, 'Was that just a fluke that you guys did that, or was it real?' And so the answer is--"
"Well, our answer is, we have a system," Gelfand says.
"Right," adds Levin. "We don't think it's a fluke. We think it's a function of how we do things, rather than, you know, did we just get lucky."
The device industry has the distinction of being both immensely important and exceedingly obscure. It is not a business that consumers can easily follow: Like the rest of us, the patient on Kirtane's operating table had little awareness of the innovations that now allow for catheterized tubes to be pushed through the bloodstream, let alone the origins of the experimental device. Still, I came to spend time with Levin and Gelfand because their medical work over the past decade promises to have more of an impact--a life-and-death impact, that is--than so much of the gadgetry that clogs the web with speculation, chatter, and tweets. At the same time, their innovative process helps explain how new ideas, rather than just new technology, can alter the future.
Read more at: http://www.fastcompany.com/3007845/meet-tech-duo-thats-revitalizing-medical-device-industry
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