Intravascular Lithotripsy (Shockwave Medical) is now available, on the European market, for the management of calcified coronary artery disease. Additionally, according to a press release, the first patient has been enrolled in the DISTRUPT CAD II post market study.
The press release reports that intravascular lithotripsy is a novel therapy designed to treat calcified artery blockages with sonic pressure waves historically used to treat patients with kidney stones. The technology is designed to minimise trauma within the artery by delivering pulsatile sonic pressure waves locally to effectively fracture both intimal and medial calcium in the artery wall but pass through surrounding soft vascular tissue in a safe manner. Additionally, it requires no specialised training with its familiar technique, and it allows physicians to use their own guidewire of choice to seamlessly integrate into the existing workflow.
The technology previously obtained CE mark on the strength of the safety and efficacy data in the DISRUPT CAD study, a premarket, prospective multicentre single-arm study conducted at seven centres in Europe and Australia that enrolled 60 patients with complex calcified coronary artery disease. The newly initiated DISRUPT CAD II study is a postmarket study that will enrol an additional 120 patients at sites across the globe, including Italy, Germany, Netherlands, Denmark, France, UK, Spain, Sweden and Belgium.
Jean Fajadet (Clinique Pasteur, Toulouse, France), co-principal investigator of the DISRUPT CAD II study, comments: “For many years, addressing challenging calcium in patients with complex coronary artery disease has been a balancing act weighing the risk of certain therapies with their clinical benefit. Now with the availability of intravascular lithotripsy, we finally have an intuitive calcium modification tool that offers the maximum benefit in increasing vessel compliance prior to stent implantation with minimal safety risks.”
Doug Godshall, CEO of Shockwave Medical, comments: “The introduction of the Shockwave coronary intravascular lithotripsy represents a significant advance not only for the treatment of calcified coronary artery disease, but also for the future growth of the company by diversifying our portfolio of IVL devices. Our initial experience with the technology over the last few months has bolstered our belief in what a meaningful impact this technology will have in the hands of operators across the globe.”
Shockwave IVL catheters are now commercially available for coronary artery disease in Europe; they are not available in the USA.