The Santa Clara, Calif.-based company’s C2 IVL (intravascular lithotripsy) catheter is designed to improve blood flow to the heart by fracturing problematic calcium using sonic pressure waves to enable stent delivery, deployment and optimal expansion. The FDA will provide Shockwave Medical with priority review and interactive communication during the device’s premarket review phase.
“Receiving breakthrough device designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease,” said Shockwave president & CEO Doug Godshall in a news release. “Our international customers have responded very positively to Shockwave’s C2 since its commercial launch last year, and our team has been working hard to bring this transformational technology to patients with coronary disease in the United States. We are encouraged that the FDA has determined that Shockwave C2 qualifies as a breakthrough device and we look forward to working collaboratively with the agency so we can make Shockwave C2 available as expeditiously as possible.”
The Shockwave system and C2 catheter are part of an Investigational Device Exemption (IDE) study approved to enroll 442 patients at 50 centers in the US and Europe. The study had enrolled 108 patients as of June 30, 2019, the company reported during its second-quarter earnings call.
Shockwave raised nearly $97 million in an initial public offering in March, inking a private-placement deal with Abiomed (NSDQ:ABMD) on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price.