Shockwave's Coronary IVL System Receives FDA Breakthrough Device Designation

September 3, 2019—Shockwave Medical, Inc. announced that the company has received Breakthrough Device designation from the FDA for the company's Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of the investigational device exemption (IDE) DISRUPT CAD III study.

According to the company, the Shockwave C2 IVL catheter is designed to fracture problematic calcium using sonic pressure waves to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.

Shockwave Medical noted the FDA Breakthrough Device program is intended to help patients and health care providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Shockwave Medical with priority review and interactive communication during the Shockwave C2 IVL catheter premarket review phase.

In January 2019, Shockwave Medical announced the commencement of DISRUPT CAD III. The prospective, nonrandomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL system with the Shockwave C2 coronary IVL catheter in de novo, calcified, stenotic, coronary arteries before stenting.

DISRUPT CAD III is approved to enroll 442 patients at 50 centers in the United States and Europe, and is led by coprincipal investigators Dean Kereiakes, MD, and Jonathan Hill, MD. As reported in the company’s second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019.

Shockwave C2 coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States, advised the company.