Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system.
IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to enroll up to 335 subjects at 47 U.S. sites.
Abbott’s study could potentially lead to yet another competitor in the hot IVL space. Johnson & Johnson currently leads the way after its 2024 acquisition of IVL leader Shockwave Medical. Boston Scientific entered the space this year, agreeing to buy Bolt Medical in January. Other companies, such as FastWave Medical, Vantis Vascular and Amplitude Vascular are making waves in IVL, too.
The current approaches for clearing calcified arterial blockages include cutting balloons and atherectomy technology. IVL, meanwhile, fractures the calcium within the artery wall. This potentially allows for vessel expansion and better stent placement. Abbott’s investigational system utilizes high-energy sound pressure waves to treat calcium blockages prior to placing a stent to achieve this.
Abbott said its investigational IVL technology builds upon its existing vascular portfolio. It aims to address the challenges of currently available IVL systems, according to a news release.
“Abbott is a leader in treating coronary artery disease, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. Through our expansive portfolio of treatment offerings, we aim to make interventions safer and more effective for people who need them most,” said Jennifer Jones-McMeans, divisional VP of global clinical affairs at Abbott’s Vascular business. “Now, by working with physicians to evaluate Abbott’s coronary IVL system, we are exploring the next generation of calcium modification technology, advancing our portfolio of treatments for coronary artery disease.”
