Israeli device manufacturer ITGI Medical announced a new partnership with Vascular Solutions. Under the new agreement, both companies will work together to land a Humanitarian Device Exemption (HDE) from FDA regulators for the ITGI Aneugraft Dx coronary covered stent.
Once the company gets approval for the device, Vascular Solutions will then distribute the stent in the United States. The Aneugraft Dx coronary covered stent is designed for the treatment of perforations and dissections of a patient’s native coronary arteries. In addition, the device can be used for the treatment of diseased saphenous vein grafts and coronary aneurysms.
Under the deal. ITGI will be in charge of the pre-clinical research phase of the device’s development. For its part, Vascular Solutions will be in communication with FDA regulators and will work to execute a clinical study of the device in the United States. The U.S. development program is slated to start during the early part of next year. In total, both companies expect the development and approval process to take up to three years.
"The U.S. market is the key target market for the company's products," stated ITGI Medical CEO Aviv Lotan. He also noted that this move was in alignment with previous disclosures, stating that 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."