Novelis is developing a technology platform based on forward-looking intravascular ultrasound (IVUS). Its initial product offerings are designed to help interventional cardiologists treat chronic total occlusions (CTOs), complete blockages of the coronary arteries, during minimally-invasive procedures in the cardiac catheterization laboratory.
The product line includes an image-guided crossing catheter that enables clinicians to safely cross CTOs in the coronary and peripheral arteries, with a reduced risk of complications such as vessel-wall perforation and dissection. Novelis is also working on an imaging-only version of the forward-looking IVUS catheter, designed to facilitate current guidewire-based CTO crossing techniques.
Volcano plans to add Novelis' products and capabilities onto its existing s5i IVUS imaging system. "The Novelis offering represents a highly complementary technology to our IVUS offering," said Volcano's president and CEO Scott Huennekens.
Clinical needs
Existing CTO treatments involve lengthy procedures that can often fail due to inadequate visualization. What's more, the lack of adequate tools to guide CTO crossing results in many patients being referred for invasive coronary artery bypass grafting. The products under development by Novelis offer the potential to shorten treatment times and minimize complications, as well as boost the total number of procedures performed.
"Catheter-based treatment of chronic coronary total occlusion is one of the remaining major clinical challenges in interventional cardiology," commented David Williams, director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Rhode Island Hospital (Providence, RI) and advisor to Novelis. "I have performed pre-clinical work with the Novelis device which, in my view, demonstrated clear differentiation of coronary anatomy and sufficient ablative power necessary to guide the interventional cardiologist safely through a CTO."
Volcano plans to file for US and international approvals on the first of several devices during 2009 and to begin commercialization of a stand-alone imaging console in the second half of 2009.
"We believe the regulatory path is fairly straightforward in all major geographies and that this offering will leverage our strong presence in the cath lab through our sales and distribution programs," said Huennekens. "At the estimated procedure volume of over 200,000 [CTO] cases per year - and factoring in the potential for market expansion - the total market potential for Novelis' CTO products is estimated at over $500 million."
He added that Volcano will also explore the potential for using Novelis' technology platform in other large markets, such as ablations for atrial fibrillation and spine therapy.