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Heart disease remains the leading cause of death in the U.S., claiming a life every 34 seconds. But beyond heart attacks or other sudden events, a quieter threat is building inside Americans’ blood vessels.
It’s called arterial calcification, an often overlooked driver of serious health complications. Now a breakthrough technology offers hope for better treatment.
What is arterial calcification? And why is it so dangerous?
When arteries become narrowed or hardened due to the buildup of plaque, it’s known as atherosclerosis. Over time, these plaques can calcify, meaning they harden into rigid, rocklike deposits that line the inner or middle walls of arteries. This process, called calcification, makes arteries less flexible and more likely to get blocked, raising the risk of heart attacks, strokes and limb loss.
Peripheral artery disease is a common result of this process. It happens when narrowed or hardened arteries reduce blood flow to the legs and feet. PAD affects approximately 230 million people worldwide, yet many don’t realize it.
Arterial calcification can also affect the arteries that supply the heart, leading to coronary artery disease. When blood flow to the heart is restricted, it can cause chest pain, shortness of breath and heart attacks. Annually, the disease results in 17.8 million deaths worldwide. Like PAD, CAD develops silently over time.
Why treatment has been so difficult
Once identified, calcified plaques are notoriously hard to treat.
Standard procedures can work well for soft plaque. Doctors thread a tiny balloon into the blocked artery, inflate it to compress the blockage, then often insert a metal mesh tube called a stent to keep the vessel open.
With calcified arteries, rigid calcium often doesn’t budge. Traditional balloons may fail to expand or cause artery tears. Similarly, stents may not fully deploy, increasing procedural complications.
In short, older tools try to push through the problem. But next-generation technology uses a different approach: preparing the artery first, helping ensure procedures are safer and more efficient.
A technology modeled on kidney stone care
Enter intravascular lithotripsy, a breakthrough therapy that borrows from an unexpected source: kidney stone treatment.
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For decades, doctors have used sound waves to break up kidney stones through a minimally invasive procedure. IVL applies the same principle inside the artery, delivering controlled sonic pulses through a modified balloon catheter to gently crack calcium deposits from within.
This approach avoids many complications of more aggressive procedures and is considered one of the most promising developments in interventional cardiology. IVL was first approved for coronary use just four years ago, with adoption growing rapidly. One early IVL company quickly became the market leader and was acquired by Johnson & Johnson in 2024 — another sign of the technology’s growing importance in cardiovascular care.
Meet the startup pioneering new IVL options
FastWave Medical is a standout innovator in the IVL space, pushing the boundaries of energy delivery and procedural efficiency to elevate outcomes in peripheral and coronary interventions.
“FastWave Medical’s novel IVL platforms offer genuine promise for addressing severely calcified coronary arteries that are difficult to traverse,” says Dr. Kathleen Kearney, medical director of the Cardiac Cath Lab at UWMC Montlake. “These technological improvements are greatly needed to empower physicians in providing more effective treatment to their patients.”
But what makes FastWave particularly noteworthy isn’t just its technology; it’s who’s backing it. Alongside venture investors, physicians — cardiologists, vascular surgeons and interventional radiologists — have invested in the company. Their involvement signals more than financial interest; it reflects confidence in the system’s potential to address the daily challenges they face in the cath lab. When physicians invest in medical technology, it demonstrates something powerful: They believe it will genuinely improve their ability to deliver high-quality care.
“FastWave is moving quickly and decisively to become best-in-class in the IVL space,” said Dr. Arthur Lee, director of peripheral vascular services at the Cardiac and Vascular Institute. “We are excited to support the development of this groundbreaking technology and get it into the hands of those who need it most.”
“Calcified arteries remain one of the most difficult conditions to treat in our field,” added Dr. Amir Kaki, director of mechanical circulatory support and high-risk coronary interventions at Henry Ford St. John Hospital. “FastWave’s IVL platform is a compelling advancement that should provide a more precise, efficient and predictable way to manage complex arterial disease.”
As of July 2025, the company holds a total of eight patents, with several more applications underway. These patents span key areas of the technology from energy delivery to catheter design. Early study results are encouraging for the company’s dual IVL platforms. In June, FastWave successfully completed initial first-in-human procedures as part of an ongoing feasibility study for its coronary laser-based IVL system. An Investigational Device Exemption is also planned to evaluate its electric IVL system for the treatment of PAD.
“Calcified lesions aren’t just a technical challenge — the condition remains one of the most significant barriers to successful peripheral interventions,” said Dr. Sahil Parikh, director of endovascular services at Columbia University Irving Medical Center. “FastWave’s upcoming IDE trial for PAD will give us a chance to assess whether an advanced IVL system can meaningfully improve the lives of patients who suffer from this difficult disease.”
Dr. Venita Chandra, clinical professor of surgery at Stanford Health Care, expects the trial to reveal whether FastWave’s device will offer doctors a better tool for difficult cases. “The key question isn’t just whether a device works but whether it makes procedures more efficient and provides physicians with a more predictable tool for treating patients with complex arterial disease,” she said.
Why this matters more than ever
The stakes are rising rapidly. As the population ages and rates of diabetes and obesity continue to climb, more patients will face PAD and CAD.
For the most difficult cases, treatment options are quite limited. But innovation is catching up. First-generation IVL introduced a new treatment paradigm; now advanced tools from startups like FastWave promise doctors more ways to treat this disease.