Shockwave Lithotripsy

Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. A press release reports that the Shockwave C2 IVL catheter is a proprietary tool 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. 

DISRUPT CAD III is a prospective, non-randomised, multicentre 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 prior to stenting. The study is approved to enrol 442 patients at 50 centres in the USA and Europe, and is led by coprincipal investigators Dean Kereiakes and Jonathan Hill. As reported in the company’s second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019.

The FDA Breakthrough Device programme is intended to help patients and healthcare 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.

Doug Godshall, president and CEO of Shockwave Medical, says: “Receiving Breakthrough Device Designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease. 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.”

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 USA.