Originally Published MX November/December 2003
COVER STORY
In the Pipeline|
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Medtech companies frequently live and die according to the strength of their ability to innovate—to develop new products that can be readily adopted into clinical practice. Few events are more likely to undermine those abilities than protracted IP litigation such as that in which Medinol has become embroiled since 2001.
In spite of such obstacles, Medinol has continued to press ahead with its product development activities, filling its pipeline with stents designed for a variety of applications. The latest version of the company's coronary stent, called Nirflex, is available in Europe and undergoing clinical trials around the world. A version of the stent called Nirside flex, designed for use in bifurcated coronary arteries, is also under development.
Medinol is also conducting extensive research into other stent applications, including those for peripheral, neurovascular, and renal use. A number of such products are currently in various stages of clinical trials.
Perhaps just as boldly, considering the company's recent experiences, Medinol is continuing to partner with other medtech companies for the advancement of its stent products. Medinol and W. L. Gore & Associates (Flagstaff, AZ) will soon launch their NOA system, the first product to result from their collaborative alliance relating to stents and stenting solutions. Announced in September 2002, the alliance is intended to make use of Medinol's leadership position in cardiovascular stent technology and Gore's recognized capabilities in expanded polytetrafluoroethylene (ePTFE) processing and materials.
The NOA system combines Medinol's Nirflex stent with Gore's ePTFE Aptera balloon. The system is designed to permit "complete stenting," allowing for direct stenting and postdilatation with a single system.
The first clinical implant using the system was performed in May at the London Chest Hospital (UK). Over the course of two days, a total of eight NOA systems were used to treat six patients. More than 50 systems were subsequently used in leading hospitals in Germany, Italy, and France. The NOA system will soon be available for sale in Europe.
Illustration courtesy W. L. Gore
Copyright ©2003 MX
