Cardiologists have long been confounded by a particular problem in treating patients with buildups of hard calcium—a condition that can shrink and stiffen their blood vessels. In the past, operating on those with calcified buildups often meant risky and difficult procedures.
Those dangers may be a thing of the past. A revolutionary process developed by medical device company Shockwave Medical utilizes sound waves generated from inside the blood vessels themselves to break up calcium deposits. The new treatment—safer and more effective than traditional methods—earned Shockwave a place on Fast Company’s list of the world’s Most Innovative Companies.
“Shockwave makes treating a calcified vessel very similar to treating an uncalcified vessel in terms of risks and outcomes,” says Doug Godshall, president and CEO of Shockwave. “The kinds of complications seen with other approaches are essentially nonexistent with ours.”
A BETTER WAY TO BREAK UP CALCIUM
Before Shockwave, cardiologists would perform a procedure called atherectomy to break up calcium deposits, which required the use of a tiny high-speed drill spinning inside a blood vessel. It was as risky as it sounds, with potential to damage the vessel or dislodge chunks of calcium into the bloodstream where they could create other issues. In many cases, the risks were enough to dissuade doctors from even attempting the procedure.
Shockwave’s technique converts electricity into mechanical energy by generating sound waves from a low-pressure balloon inserted into the vessel by catheter. The sound waves’ energy passes through soft tissue but shatters the relatively brittle calcium deposits. Doctors have long used sound waves to break up kidney stones, but the process had never been applied intravenously for cardiovascular disease.
It took five years of iteration and testing to create a device that had enough power but was small enough and packaged correctly to be safe and effective. In 2016, the procedure was first cleared in the U.S. for use in peripheral arteries outside of the chest and abdomen; in 2021, the FDA approved the product for use in coronary arteries.
A CULTURE OF INNOVATION
The idea behind Shockwave was born in a med-tech incubator where entrepreneurs Daniel Hawkins and John Adams were looking for unmet medical needs. That willingness to bring a new perspective to longstanding practices is the bedrock of the company’s culture of innovation.
Take marketing, for instance. Shockwave took a unique approach to get its product into the marketplace, leaning heavily on social media posts by cardiologists who lauded the company’s sound-wave technology. Shockwave curated those posts as case studies to spread the word to other clinicians. “It created this tremendous buzz,” Godshall says. “It far outstripped what we would have been able to do with our 120 salespeople in the field.”
For U.S. cardiologists who are now using Shockwave devices to treat a small but growing number of patients with calcified arteries, the company promises more features and innovations in models to come. Take, for example, its line of calcium-deposit-fracturing intravascular lithotripsy devices—it currently offers three products but is aiming to have 10 in the next six years. And by the end of the decade the company hopes to move beyond treating arteries with products that retain focus on other calcium-related issues—like calcified heart valves.
“It is a really simple tool, but a radical idea,” Godshall says. “We democratized the treatment of calcium—and dramatically reduced the potential of complications for patients.”