To: jasper asper who wrote (1179 ) 6/14/1998 10:43:00 PM From: Jeffrey L. Henken Respond to of 2887
Perhaps it's time to look at the OmniStent again. Hopefully sometime in the next year we will see these stent designs enter phase I testing. Remember the bifurcated design is very similar to the Talent system that World Medical is currently testing for a $400 million a year market. Here is some information from the 10K:sec.gov The Company's stent technology is protected by two patents, US Patent No. 5,342,387 issued August 30, 1994 titled Artificial Support for a Blood Vessel, and US Patent No. 5,607,445 issued March 4, 1997 titled Method and Apparatus for Making a Stent. In addition, on January 8, 1998 the Company received a Notice of Allowance from the US Patent and Trademark Office for the Company's stent delivery system. All patents are assigned to the Company. The Company's patent includes a proven biocompatible coating used to coat the interior surface of artificial hearts. This neutralized collagen compound is considered to be one of the most blood- and tissue-compatible biomaterials used to construct a smooth blood flow around the device. When applied as a thin film it provides a smooth, biochemically stable protein coating with non-pseudo intimal properties, very little platelet adhesion, and high blood compatibility. In addition, when used as a substrate, the coating bonds easily with various anticoagulant molecules such as Heparin and phospholipids which are used to further reduce thrombosis. The Company has developed a concept for covering its stents with graft material and plans to file a patent on this process in the future. The endoprosthesis will enable the Company to become active in the endovascular graft market. The greatest advantage in using the endless loop, self-expanding metals is the potential for generating mural pressures within a stenosis sufficient for precise stent-vessel apposition. Once the vessel is acutely dilated, the stent could be passed through the stenosis on a guide wire, in its endless, elongated configuration, then released to allow the coils to reform at the stenosis. The gradual mural pressure of the "memory" reforming coil produces a subsequent chronic vessel dilation over a period of several hours or days until the "memory" diameter of the coil is reached. This could greatly impact the restenosis problem in that the acute trauma of angioplasty (i.e., rapid vessel wall stretching, dissection of internal elastic lamina and media) could be modulated over the succeeding days after angioplasty by gentle though constant vessel wall "remolding." The OmniStent(TM) has several advantages over competitive products. It is a dual, endless coil which gives the stent versatility in using almost any material; the dual coil gives more than two times the hoop strength of a single coil; the continuous loop allows easy deployment whether on a balloon, guidewire, or through a sheath (such as the Schneider Wallstent). When coiled, according to the reversible arcuate sections (the preferred embodiment in US Patent 5,342,387), the open sections can be used to place at vessel branches allowing open flow into these branches. In addition, the patent claims a bifurcated stent made of the same endless loop, that presents wide applications in peripheral stenting and grafts (the aortoileal stenosis is the most common pathology in peripheral vascular disease). The endless, bifurcated stent can thus be inserted into both iliac vessels from a unilateral (one puncture) technique. It is the most versatile stent in the interventional field. Regards, Jeff