CryoLife (Kennesaw, Georgia), an implantable biological medical device and cardiovascular tissue processing company, has taken a significant step towards bringing its BioFoam Surgical Matrix to the U.S. market. The FDA has granted the company an investigational device exemption to conduct a human clinical trial for the product. (Medical Device Daily)
Patients with carotid artery disease – caused by plaque buildup in the carotid arteries that reduces blood flow – are at risk of a stroke because of the potential for clots to form on the plaque and block the blood flow. But carotid artery stenting (CAS), a procedure commonly used to treat the disease, also poses a risk of stroke because sometimes a piece of the plaque can break away and travel to the brain. (Medical Device Daily)
When W. L. Gore & Associates (Flagstaff, Arizona) received FDA approval for the Gore TAG Endoprosthesis System in 2005, it was a significant step forward in the treatment of thoracic aortic aneurysms (TAAs), which until then had traditionally been treated with highly invasive open surgery that required a large incision in the patient's chest. In the four years since the device has been approved in the U.S. the company has collected physician feedback and designed a next-generation version of it – the Conformable Gore TAG device – that is now being studied in three U.S. clinical trials. (Medical Device Daily)
Nanosphere (Northbrook, Illinois), a company that develops molecular diagnostics systems, reported the pricing of its previously disclosed underwritten public offering of 4.7 million shares of its common stock at a price of $7 a share. (Medical Device Daily)
A device made by Lumalier (Memphis, Tennessee) is showing promise in its ability to clean hospital rooms using ultraviolet germicidal energy to decontaminate air and surfaces. (Medical Device Daily)