Is Cardica also developing additional devices with Cook Medical to facilitate vascular closure and other surgical procedures? Do patients with PFO may be at increased risk for several serious medical conditions, including stroke and systemic embolism, because blood clots can pass directly through the hole and into the main circulation? Does the Cardica closure device provide patients with a direct minimally invasive alternative to current treatments to permanently close the hole in the heart?
IIP > read on here > http://www.marketwatch.com…
…today announced that it received a $1 million milestone payment from Cook Medical (Cook) for the successful development of a specialized automated device used to close holes in the heart known as patent foramen ovales (PFO), a relatively common heart defect present in 15 to 20 percent of the general population…
In June 2007, Cardica and Cook entered into an agreement to develop a PFO closure device, whereby Cardica is responsible for the design, production and manufacturing, which is directed by a development committee with representatives from both companies. Cook is responsible for preclinical and clinical development, as well as regulatory approval of the product, and, subject to regulatory approval will have exclusive worldwide commercialization rights to market the PFO closure device. Cardica has received a total of $3.1 million to date under the agreement. Cardica also is eligible to receive additional payments, of up to $500,000 over the next year if specified milestones are met, as well as royalties on future worldwide sales, if any…
A PFO is a very common structural genetic heart defect. During fetal development, the heart’s two upper chambers are connected by a hole that allows blood to be diverted away from the lungs because they are not yet developed. This hole, called the foramen ovale, is necessary for healthy fetal development and closes naturally by age two in approximately 80 percent of the general population. When it remains open after this period, it is said to be patent.
People with PFO often are asymptomatic, but they are at greater risk for stroke, systemic embolism and debilitating migraine headaches because routine blood clots are passed from the right atrium to the left atrium, bypassing the lungs where they are typically filtered out. The National Stroke Association estimates that approximately 100,000 people in the United States suffer PFO-related strokes each year. In addition, several studies suggest that up to 50 percent of the 3 to 6 million patients suffering from migraine headaches preceded by aura may have a PFO.With larger PFOs, patients may experience labored breathing, recurrent respiratory infections and heart failure or death. Today, PFOs are treated by the use of a blood thinning medication (aspirin or warfarin) to prevent blood clots, or surgically through an open chest or transcatheter closure procedure…