Research Project
2536795
The annual worldwide market for electrosurgical blades used for cutting and coagulation exceeds 100 million . Sales of coated surgical blades are increasing compared to the widely used stainless steel blade. These coated blades, although less sticky than the stainless steel blade, are less safe, more expensive, and limited in their application. MedQuest Products Inc. proposes to develop and commercialize an innovative Titanium Nitride (TiN) coated blade which corrects the deficiencies of existing coated blades while retaining the simplicity, robustness, and cost-effectiveness of the stainless steel blade. The feasibility of this innovative concept has been proven in successfully tested prototypes. The CleanCut blade has several advantages over other coated blades. It is reliable, durable, reduces tissue adherence, increases safety, and is more manufacturable. It also offers the potential of reusability. A proprietary coating process makes a TiN coated blade as versatile as a stainless steel blade while providing better performance. The goal of Phase I activities will be to refine the manufacturing process and test the blade design. Phase II activities will aim to optimize the coating for a variety of working conditions, validate the design, and submit a 510(k) to the FDA for commercialization in the United States. PROPOSED COMMERCIAL APPLICATION Approximately 14 million open electrosurgical procedures are performed each year in the U.S. alone. The annual U.S. market for electrosurgical blades is about 86 million. The annual worlwide maarket for electrosurgical blades is estimated to be 112 million. MedQuest Prodeucts" CleanCut blade will replace presently used stainless steel and coated blades. A 10-15 percent market share might provide annual CleanCut sales of 11-17 million. In addition, the CleanCut has the potential to see increased use in developing countries, since its potential reusability and lower cost may make it very cost-effective.
