Volcano (Rancho Cordova, California), Stanford University (Palo Alto, California), Cardialysis (Rotterdam, the Netherlands) and the Cardiovascular Research Foundation (CRF; New York) have formed an agreement focused on Volcano’s provision, free of charge, of intravascular ultrasound (IVUS) catheters for use in pivotal drug-eluting stent (DES) clinical trials.
Volcano said that the offer will be made available to stent manufacturers using the core lab services of Stanford, Cardialysis or CRF in trials where IVUS images and data are planned to be collected in 100% of patients at enrollment and at pre-determined follow-up periods. It said that the goal is to provide the industry, physicians and patients a more in-depth understanding of stent thrombosis and the most definitive answers to questions surrounding the long-term safety of current and next-generation DES.
IVUS is designed to precisely visualize late stent mal-apposition (when the coronary vessel grows away from the implanted stent months or years after deployment), one of the possible suspects in the search for the cause of late stent thrombosis in DES.
Volcano offers a suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart diseases and guide optimal therapies. The company’s IVUS product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab and single-use phased array and rotational IVUS imaging catheters.