Research Medical licenses first peripheral reperfusion kit for ischemic limb salvage.SALT LAKE CITY--(BUSINESS WIRE)--July 9, 1996--Research Medical Inc. (NASDAQ/NMS:RMED) Tuesday announced that it has exclusively licensed a peripheral limb reperfusion re·per·fu·sion n. The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack. kit from Paul Walker, M.D., Ph.D., Surgeon-in-Chief, and Alex Romaschin, Ph.D., The Toronto Hospital. The main components of the kit consist of a line of balloon reperfusion catheters and specialized solutions to facilitate flushing an ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic (oxygen-starved) limb free of toxins. These toxic metabolites Metabolites Substances produced by metabolism or by a metabolic process. Mentioned in: Interactions accumulate in the ischemic muscle tissue of patients undergoing procedures where blood flow has been compromised, such as embolectomies, peripheral vascular grafting, and abdominal aortic aneurysm abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105 repair. The company estimates this reperfusion kit could be utilized in over 240,000 such procedures annually worldwide, with a potential market value in excess of $110 million. Research Medical will be the first to introduce this new technology into the vascular surgery arena. Dr. Walker, a widely known vascular surgeon, and his team have conducted twelve years of extensive research to link toxin build-up in ischemic limbs with systemic complications such as renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, , heart attacks or arrythmias, and lung failure following certain vascular procedures. "In addition to the local muscle tissue damage, return of circulation to an acutely ischemic extremity carries an unacceptably high mortality rate, often up to 20 percent," said Walker. "Our reperfusion strategy is aimed at reducing both local and systemic side effects." The balloon-tipped reperfusion catheters and proprietary solutions offer a convenient, effective method of removing toxins from tissues, thereby preventing systemic damage to other organs in the body as well as preserving the affected tissues. "This new peripheral vascular reperfusion kit is a logical extension of the firm's existing muscle preservation technology -- presently utilized to protect the heart muscle in open-heart surgery," said Gary L. Crocker, president and chief executive officer. "This innovative technology creates an entirely new market in vascular medicine, bringing to surgeons a new tool to salvage limbs, save lives and reduce the incidence of heart and other organ complications," continued Crocker. "The company envisions this new limb reperfusion kit as the first of several applications for an emerging family of reperfusion products, future applications of which may involve the salvage of organs and other tissues" Crocker said. "Moreover, the kit ideally complements our line of vascular products currently being sold and under development, including viewing embolectomy embolectomy /em·bo·lec·to·my/ (em?bo-lek´tah-me) surgical removal of an embolus. em·bo·lec·to·my n. Surgical removal of an embolus. embolectomy surgical removal of an embolus. , thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. , occlusion and irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice. catheters, and several peripheral vascular shunts for stroke therapy. "Perhaps most importantly, this new reperfusion product -- in conjunction with these other new vascular products as well as the Heparin Removal Device and Autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. Fibrinogen Fibrinogen The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion Delivery Kit in Europe -- enhances our earnings per share prospects for Fiscal 1997." Human clinical trials using the limb reperfusion kit, preparatory to 510(k) filing, will be initiated in August at The Toronto Hospital and at least one other clinical site. The clinical trials will compare standard vascular procedures without the benefits of the new vascular reperfusion technology with the results of similar procedures utilizing the reperfusion kit. Research Medical anticipates marketing the kit initially in international markets during the third quarter of Fiscal 1997. Within the next six months the company will be filing several 510(k) applications with the U.S. Food & Drug Administration for authorization to market the various components of the kit in this country. The company is pursuing patent positions on the delivery and recovery aspects of the reperfusion kit as well as the specialized solutions. Located in Midvale, Utah, Research Medical (RMED) is a diversified biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. firm specializing in the development, manufacture and sale of hospital disposable products primarily for cardiovascular and vascular surgery, as well as specialty pharmaceuticals. CONTACT: Research Medical Inc., Midvale Nancy E. Schultz, 801/562-0200 |
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