Medtronic ($MDT) has launched a new clinical trial involving a next-generation version of its CoreValve transcatheter aortic valve implantation system, even as it continues a patent battle with Edwards Lifesciences ($EW) over the core technology.
Plans call for testing the Minnesota device giant's CoreValve Evolut R Recapturable System with up to 60 patients who have severe symptomatic aortic stenosis and are at high risk for the alternative treatment--open-heart surgical aortic valve replacement. Clinicians will test the system in Melbourne, Australia, where the first surgeries have already taken place. But trial-related implants are also slated for hospitals in Bonn, Germany; Belfast, Northern Ireland; and London.
Medtronic's new TAVI system includes the transcatheter valve itself--the CoreValve Evolute R, which is designed to seal and fit better, and the company's EnVeo R Recapturable Delivery system, which uses less catheter to get the job done. Endpoints for the study include, in part, survival and stroke rates at 30 days, plus success of the device from 24 hours to 7 days.
Earlier this year, the U.S. Supreme Court rejected Medtronic's effort to overturn a trial loss to Edwards, which had sued for patent infringement over its market-leading Sapien transcatheter aortic valve. Edwards gets to keep its $83.6 million award, and gained the right to seek an injunction on future sales.
While CoreValve doesn't have FDA approval yet, it has been CE marked. Edwards has fought hard against CoreValve sales in Europe, too. A German court ruled that CoreValve violated Edwards' Sapien patent and awarded an injunction on CoreValve sales in that country. Medtronic is betting it will ultimately prevail, however, and it is appealing the German court's ruling. Separately, the company is seeking to get the Sapien patent claim invalidated in the European Patent Office--hence the continued clinical studies.
Medtronic grabbed CoreValve in 2008 for $700 million, so executives are doing everything they can to protect their rather sizable investment.
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