Fast Company

When sound saves lives

MEDICAL DEVICE INNOVATOR SHOCKWAVE INTRODUCES A RADICAL NEW WAY TO TREAT CARDIOVASC­ULAR DISEASE

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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 highspeed 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.”

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R&D TEAM meet with CEO Doug Godshall (seated, center) weekly to assess the progress of current projects and pitch new ideas.
SHOCKWAVE’S R&D TEAM meet with CEO Doug Godshall (seated, center) weekly to assess the progress of current projects and pitch new ideas.

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