MIV Therapeutics Cites Literature Demonstrating Critical Need For Company's Device To Prevent Stroke
Atlanta, GA - MIV Therapeutics Inc., a leading developer of next-generation biocompatible coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, has cited a number of recent publications that sharply define the critical need for new technology the Company is developing to prevent the most common and serious type of stroke associated with heart surgery and other procedures.
MIVT's wholly owned subsidiary, SagaX Inc., has entered a rapid phase of testing and regulation for its Aortic Embolic Protection Device (AEPD), a novel and proprietary approach to prevent embolic strokes that are created during and after cardiac surgery. Located in Herzlyia, Israel, MIVT's SagaX subsidiary is developing a range of advanced biomedical technology.
MIVT expects to be able to begin commercializing the AEPD in Europe within 12 months and in the United States within 24 months.
The AEPD works by diverting particles in the bloodstream that might otherwise reach the brain and cause strokes that can cause irreversible damage to the delicate tissue of the brain. The company expects to begin clinical studies within 4 months in advance of commercializing the product.
Scientific publications in some of the most prominent medical journals in the field show the rate and severe consequences of stroke following heart surgery. The article "Perioperative Stroke," was published on February 15, 2007, in the New England Journal of Medicine, by Dr. Magdi Selim from the Department of Neurology, Beth Israel Deaconess Medical Center, Harvard University, Boston.
In the article Dr. Selim states, "Stroke is one of the most feared complications of surgery."
The risk of stroke varies by patient factors and type of surgery, but with an average stroke rate in heart surgery at 4.6%, the number of stroke victims is alarming. In 2004, for example, 646,000 patients underwent heart surgery, resulting in an estimated 29,700 patients suffering stroke.
According to the article, in isolated Coronary Artery Bypass Grafting (CABG) the rate of stroke is 1.4% to 3.8%. In combined CABG and heart valve surgery, the rate is 7.4%. In valve surgery alone, the rate is 4.4% to 8.8%, while in double-valve surgery it is 9.7%. In aortic repair it is 8.7%.
The recent New England Journal of Medicine article adds important additional understanding of the problem as outlined in earlier publications and studies, such as a 2003 article in the journal "Stroke," authored by Dr. Likosky et al, entitled, "Determination of etiologic mechanisms of strokes secondary to coronary artery bypass graft surgery."
Dr. Likovsky's article assessed 388 patients who suffered from stroke following CABG operations. Of the strokes, 62% were embolic. The timing of embolic strokes after surgery had a bimodal distribution, with approximately 45% of perioperative strokes identified within the first day after surgery. The remaining 55% occur after uneventful recovery from anesthesia, from the second postoperative day onward.
"These scientific data show that the extent of stroke following heart surgery is alarming, and very clearly demonstrate the need to capture these embolic particles before they can reach the brain and cause damage," said Dr. Dov Shimon, Chief Executive Officer of SagaX. "Treatment with medications has not yet been satisfactory. The data indicates that treatment to prevent stroke should extend for at least three days after surgery."
Stroke is the third leading cause of death, and the leading cause of disability. According to a recent publication of the American Heart Association (AHA), each year about 700,000 Americans experience a new or recurrent stroke. About 500,000 of these are first attacks, and 200,000 are recurrent attacks. It is also stated that the estimated direct and indirect cost of stroke in the US alone for 2006 is $57.9B.
SOURCE: MIV Therapeutics Inc. and SagaX Inc .