FDA News

FDA grants breakthrough device designation for coronary intravascular lithotripsy

Shockwave Medical announced that the FDA has granted a breakthrough device designation to its intravascular lithotripsy device for the treatment of complex calcified CVD.

The device (Shockwave C2 IVL catheter) is designed to fracture calcium in coronary arteries using sonic pressure waves, which facilitates delivery of stents, according to a press release from the company.

The breakthrough device designation means the FDA will give the product priority review and interactive communication during the approval process, according to the release.

The device is currently being tested in DISRUPT CAD III, an investigational device exemption study, in which 442 patients are expected to be enrolled, according to the release.

“Receiving breakthrough device designation is an important milestone, validating [intravascular lithotripsy] as a unique solution for complex calcified coronary disease,” Doug Godshall, president and CEO of Shockwave Medical, said in the 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.”

Disclosure: Godshall is an employee of Shockwave Medical.

Shockwave Medical announced that the FDA has granted a breakthrough device designation to its intravascular lithotripsy device for the treatment of complex calcified CVD.

The device (Shockwave C2 IVL catheter) is designed to fracture calcium in coronary arteries using sonic pressure waves, which facilitates delivery of stents, according to a press release from the company.

The breakthrough device designation means the FDA will give the product priority review and interactive communication during the approval process, according to the release.

The device is currently being tested in DISRUPT CAD III, an investigational device exemption study, in which 442 patients are expected to be enrolled, according to the release.

“Receiving breakthrough device designation is an important milestone, validating [intravascular lithotripsy] as a unique solution for complex calcified coronary disease,” Doug Godshall, president and CEO of Shockwave Medical, said in the 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.”

Disclosure: Godshall is an employee of Shockwave Medical.