Rubicon Medical Initiates Second European Clinical Study with the Rubicon Filter; First Human Carotid Artery Cases Successfully Completed in Germany.Business Editors/Health/Medical Writers SALT LAKE CITY & HAMBURG, Germany--(BUSINESS WIRE)--Oct. 22, 2003 Rubicon Medical Corp. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :RMDC RMDC Records Management and Document Control (program office) RMDC Ribbon Mild Detonating Cord RMDC Radio Metric Data Conditioning ), a Salt Lake City-based developer and manufacturer of medical devices and products, today announced it has successfully completed the first human cases of its Rubicon Filter in the carotid arteries Carotid arteries The four principal arteries of the neck and head. There are two common carotid arteries, each of which divides into the two main branches (internal and external). Mentioned in: Endarterectomy . Rubicon's carotid carotid /ca·rot·id/ (kah-rot´id) pertaining to the carotid artery, the principal artery of the neck. ca·rot·id n. studies are being conducted by Prof. Dr. Juachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention in Hamburg, Germany and Rubicon's principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences for its clinical studies seeking clearance for use of the Rubicon Filter in carotid arteries. "The Rubicon Filter performed superbly in the three initial carotid cases performed here in Hamburg. We were particularly impressed with the filter's small profile, ease of use and simple retrieval mechanism," Schofer said. "It is my opinion that the Rubicon Filter will play a key role in the field of embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism. em·bol·ic adj. 1. Relating to, or caused by an embolus or embolism. 2. Relating to emboly. protection devices because of its unique features. Those features that will benefit patients undergoing carotid artery carotid artery n. 1. An artery that originates on the right from the brachiocephalic artery and on the left from the aortic arch, runs upward into the neck and divides opposite the upper border of the thyroid cartilage, with the external and stenting." The carotid arteries are found in the neck and feed blood directly to the brain. Carotid artery stenting is often performed on carotid arteries that have developed blockages as a result of plaque buildup on the artery walls. A stenting procedure involves deploying a small wire mesh wire mesh, wire netting n → tela metálica tube known as a stent inside a partially blocked blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. to improve blood flow by propping open the blood vessel. Helping physicians prevent embolic events from occurring during and after carotid stenting Carotid stenting (CAS) is a minimally-invasive surgical procedure available to correct carotid stenosis (narrowing of the carotid artery lumen by atheroma). Carotid stenosis can present with no symptoms (diagnosed incidentally) or through symptoms such as transient ischemic attacks is critical to maintaining blood flow through arteries in the brain and ensuring patient health. The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. than other embolic protection devices. Rubicon believes the Rubicon Filter is the world's smallest-profile embolic filtration device. Rubicon also believes the filter's small profile should considerably decrease trauma to the body and the risk of dislodging particles during passage of the filter through a blockage in a blood vessel. "First, we are honored to be working with Professor Schofer and Dr. Tubler, as well as with the cath lab personnel in Hamburg at one of the leading carotid centers in Germany," said Richard Linder, president and chief executive officer of Rubicon Medical. "We are further grateful to Professor Shofer for his work as the principal investigator of the RULE-Carotid, Europe study using the Rubicon Filter in carotid artery stenting. We are also thrilled with the initial successful results of the Rubicon Filter in this indication and look forward to completing the carotid study in the coming months. "Additionally, with each new procedure, we grow more and more confident that the Rubicon Filter will revolutionize the field of embolic protection. We also see a growing number of potential applications for our technology." Rubicon anticipates enrolling additional carotid patients for ongoing trials of the Rubicon Filter in Germany and Italy. About Rubicon Medical Rubicon Medical Corporation (www.rubiconmed.com) is a Salt Lake City-based developer and manufacturer of interventional vascular medical devices and products. The company focuses on minimally invasive endovascular techniques and products that are safer and more cost effective than surgery. Forward Looking Statements: All forward-looking statements in this release are based upon information available to the company on the date of this release. Any forward-looking statements involve risks and uncertainties, including those risks and uncertainties described in the company's filings with the Securities and Exchange Commission, that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, whether as a result of new information, future events or otherwise. Rubicon's Rubicon Filter has not yet been approved for sale in the U.S. or Europe, and no assurance exists that such approvals will be obtained. Readers should not place undue reliance on these forward-looking statements. |
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