Shockwave Medical Launches Coronary Intravascular Lithotripsy in Europe
May 24, 2018—Shockwave Medical announced the European commercial availability of the company’s intravascular lithotripsy (IVL) technology for calcified coronary artery disease (CAD), as well as the enrollment of the first patient in the DISRUPT CAD II postmarket study.
DISRUPT CAD II will enroll an additional 120 patients at sites across the globe, including Italy, Germany, the Netherlands, Denmark, France, United Kingdom, Spain, Sweden, and Belgium. The Shockwave IVL catheters are not available in the United States.
CE Mark approval for the IVL technology was supported by the safety and efficacy data from the DISRUPT CAD study, a premarket, prospective, multicenter, single-arm study conducted at seven centers in Europe and Australia that enrolled 60 patients with complex calcified CAD.
According to the company, IVL treats calcified artery blockages with sonic pressure waves historically used to treat patients with kidney stones. The technology minimizes 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, IVL requires no specialized training and allows physicians to use their guidewire of choice to integrate into the existing workflow.
The Shockwave coronary IVL system complements the existing large- and small-diameter peripheral IVL catheters, which have been available in Europe for the treatment of calcified peripheral disease from the iliac arteries down to the foot since 2015 and early 2018, respectively.
Similar to the peripheral IVL systems, the Shockwave coronary IVL system includes a compact, battery-powered generator; a simple and quick handheld connector cable with a single therapy delivery button; and an intuitive catheter, which houses an array of lithotripsy emitters enclosed in an integrated balloon. The catheter is delivered to a lesion similar to standard interventional techniques and on the physician’s choice of guidewire.
Jean Fajadet, MD, Coprincipal Investigator of the DISRUPT CAD II study, commented in the company's announcement, "For many years, addressing challenging calcium in patients with complex CAD has been a balancing act weighing the risk of certain therapies with their clinical benefit. Now with the availability of IVL, 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.” Dr. Fajadet is Codirector of the Interventional Cardiovascular Group at Clinique Pasteur in Toulouse, France.
The first patient in the trial was enrolled by Prof. Jonathan Hill, MD, at King’s College in London, United Kingdom. Prof. Hill stated, "Having used IVL in both a clinical trial setting as well as in our everyday clinical practice for complex patients, it’s clear that this is a game-changing technology for the treatment of calcified CAD." Prof. Hill continued, "A more widespread introduction of this technology will significantly augment our ability to modify calcific lesions. It is a highly accessible technology, which is simple to use and can be rapidly deployed in the cath lab.”