Shockwave Medical Inc. said Tuesday that its intravascular lithotripsy (IVL) therapy has won U.S. FDA approval for the treatment of severe coronary artery disease (CAD). The technology, which was granted breakthrough device designation in 2019, is a novel application of lithotripsy, which has long been used to safely shatter kidney stones.

Tuesday’s PMA approval is for the Shockwave C2 coronary IVL catheter. The Shockwave IVL system and peripheral catheters – Shockwave M5 and Shockwave S4 – have been cleared for use in the U.S. since 2016. Like the company’s other catheters, the C2 pairs with the system that uses the local delivery of sonic pressure waves to break up and modify calcified plaque in arteries.

Conventional treatments such as balloons use high pressure from inflation to fracture plaque, while atherectomy drills through the calcium to open the artery. By contrast, IVL sends shockwaves through soft arterial tissue, creating tiny cracks where they encounter calcified plaque. This allows the artery to be expanded at low pressure, enabling safe implantation of a stent to improve blood flow.

The minimally invasive Shockwave IVS system with the Shockwave C2 coronary IVL catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

The FDA based its approval on the pivotal DISRUPT CAD III trial. The prospective, multicenter, single-arm, global IDE study met the primary safety and effectiveness endpoints with a 30-day freedom from major adverse cardiovascular events (MACE) rate of 92.2% (p<0.0001) against a safety performance goal of 84.4%. the procedural success rate was 92.4% (p<0.0001), compared with the effectiveness performance goal of 83.4%.

On the primary effectiveness endpoint of procedural success, the individual endpoints included successful stent delivery in 99.2% of patients, a residual stenosis of less than 50% in all cases and no in-hospital MACE in 93.0% of patients. The results were published in the Journal of the American College of Cardiology.

“Obtaining FDA approval for this transformational technology marks a significant advance in the treatment of patients with calcified coronary lesions, and is the culmination of years of technical research, rigorous clinical studies and key learnings from our real-world global experience,” said Dough Godshall, Shockwave’s president and CEO. “We are eager for U.S. cardiologists to have access to this technology and experience how a safe, efficient and predictable calcium modification strategy can positively impact their clinical outcomes.”

Shockwave’s coronary technology is already available in 50 countries, with more than 25,000 patients treated since early 2018. With approval of the C2 catheter, coronary IVL is now commercially available in the U.S. as well.

During a November earnings call, Godshall highlighted efforts by the Santa Clara, Calif.-based company to prepare for C2’s U.S. launch, including expanding its field team and growing to nine area directors. The company also enlisted several leading interventional cardiologists to help educate its team on complex coronary interventions.

“We believe that the best approach to the C2 launch is the progress is to progress in a deliberate way through a focused list of targeted accounts,” Godshall said at the time.

Following an investor meeting in January, Wells Fargo senior analyst Larry Biegelsen said Shockwave seemed “well prepared for coronary launch and sounds comfortable with U.S. coronary Street estimates for 2021” of about $23 million.

“SWAV says clinicians believe that at least 15% of PCI procedures should be getting some type of calcium modification but only 5% are being treated currently (atherectomy). SWAV believes that its IVL (intravascular lithotripsy) could represent the incremental 10%, from 5% today to 15% penetration in the future,” Biegelsen wrote.

As such, the company sees a clear target of roughly 90,000 procedures, he said, adding the company believes the 15% penetration goal could move higher if coronary IVL wins reimbursement.