Shockwave Medical testing new-look IVL technology on challenging coronary lesions
Shockwave Medical, the Johnson & Johnson MedTech company known as a pioneer of intravascular lithotripsy (IVL) technology, has launched a new study evaluating the use of its Shockwave Javelin Coronary IVL Catheters and new-look forward IVL platform to treat difficult-to-cross calcified coronary lesions.
Shockwave Medical’s new IVL platform delivers ultrasonic shock waves using a single distal emitter. Its spherical energy field extends beyond the catheter’s tip, delivering the IVL treatment closer than traditional balloon-based devices.
“Our commitment to realizing the full potential of IVL to optimize cardiovascular care is unwavering, and we believe Javelin has the promise to transform how interventional cardiologists treat patients with tight, challenging-to-cross, calcified coronary lesions,” Nick West, MD, Shockwave Medical’s chief medical officer, said in a prepared statement. “We look forward to learning more about how our enhanced IVL capabilities could lay the foundation for a new era of treatment that improves outcomes for these complex patients.”
Shockwave previously launched similar Javelin catheters designed to treat patients with peripheral artery disease.
First patient treated in New York
The FORWARD CAD investigational device exemption (IDE) study will enroll up to 158 patients across 35 different U.S. and U.K. treatment sites. All patients will have moderate-to-severely calcified, stenotic de novo coronary artery lesions. In addition, they will either present with stable angina or undergo treatment following stabilization after acute coronary syndrome.
The trial’s first patient was treated by Evan Shlofmitz, DO, and Ziad Ali, MD, DPhil, at St. Francis Hospital and The Heart Center in Roslyn, New York.
“There is an opportunity to improve the treatment of cardiovascular patients with tight, calcific lesions in narrowed coronary vessels that are challenging to cross with balloon-based approaches as currently we have to rely on atherectomy technologies,” Shlofmitz said in the same statement.
“We are delighted to enroll the first patient in the FORWARD CAD clinical trial to determine whether Shockwave’s novel forward IVL platform can help reduce the recognized risks of atherectomy in this patient population,” added Ali.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.