The U.S. coronary stent market is already crowded and competitive, but Israel's ITGI Medical sees room for at least one more player. It recently inked a deal with Vascular Solutions ($VASC) that addresses the regulatory process and then marketing for its pericardium-covered stent, once it is approved for use.
"The U.S. market is the key target market for the company's products," ITGI CEO Aviv Lotan said in a statement, noting that it is in line with previous disclosures that "U.S. clinical development and the regulatory review process will commence only with a strategic partner that would bear part of the costs and assist in advancing the process."
First, they'll work together to pursue the U.S. regulatory process for ITGI's Aneugraft Dx coronary covered stent, which has had a CE mark since 2011. A U.S. clinical trial process is slated to begin during the 2014 first quarter. They'll seek FDA approval under the agency's Humanitarian Device Exemption process, and once that's in place, Vascular Solutions will distribute the product in the U.S. It's designed to treat conditions including coronary aneurysms, diseased saphenous vein grafts, and also perforations and dissections of native coronary arteries.
Stent companies are making products of all different sizes, with variations in delivery mechanisms and construction of the stents themselves designed to help them stand out. ITGI makes its claim to uniqueness, in part, based on its concept (pericardium-covered stent) and the way it is delivered (flexible delivery system that allows tracking through difficult blood vessels).
Neither side is disclosing financial terms of the U.S. development deal, but ITGI said it will handle preclinical research. Vascular Solutions, on the other hand, has agreed to take on all the heavy lifting in terms of FDA interaction and the U.S. clinical study. If all goes well, the product could complete the U.S. development and regulatory review process in up to three years, according to the deal announcement.
Vascular Solutions is a steady, but smaller competitor in the medical device space. But it faces a lot of pressure from larger rivals. In May, for example, Terumo defeated Vascular Solutions in a patent fight, and Vascular decided to stop selling the device in question without admitting any infringement--its R-Band Radial Hemostasis Device, which wraps around a patient's wrist to stop access-point bleeding after an arterial access procedure.
- read the release
Terumo prevails in patent suit against Vascular Solutions
ITGI completes development of pericardium-covered stent
Cardiologist group removes 'inappropriate' from stent use guidelines