A Medical Device Daily

Edwards Lifesciences (Irvine, California), a leader in the development of heart valve technologies, reported entering into an agreement with St. Jude Medical (St. Paul, Minnesota) resolving patent infringement litigation between them.

The lawsuit in question was initiated by Edwards in June 2000, related to certain of its patents in the areas of heart valve repair and replacement.

With the settlement, Edwards will receive a one-time cash payment of $5.5 million; St. Jude will receive paid-up licenses for certain of its heart valve therapy products. Further details of the settlement were not disclosed.

The litigation, filed in U.S. District Court in California and the Federal Court of Canada in Ontario, has been dismissed, Edwards said.

Edwards said that the settlement would have no “material“ impact on its finances.

“We are pleased to have resolved this dispute, as it marks the conclusion of a related group of lawsuits we filed against several competitors alleging infringement of some of our core heart valve therapy intellectual property,“ said Michael Mussallem, Edwards' chairman and CEO, in a statement. “We are committed to protecting the interests of Edwards and our clinician-inventor partners, with whom we work to create new technologies for the treatment of advanced cardiovascular disease.“

Edwards bills itself as the No. 1 heart valve company in the world and the global leader in acute hemodynamic monitoring. Its brands include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, Perimount and Swan-Ganz.

St. Jude Medical is a competitor in the cardiovascular space.

In other legalities: Terumo Europe (Terumo, Belgium), an affiliate of Terumo (Tokyo), reported receiving a payment for damages in the amount of EUR 590,869 from Biosphere Medical (Rockland, Massachusetts), in accordance with a judgment rendered in favor of Terumo Europe in November.

Terumo said that Biosphere announced, in November 2002 “in an unanticipated manner,“ its decision to terminate the exclusive distribution agreement signed in January 2002 with Terumo Europe for the products named Embosphere and Embogold, hydrophilic microspheres used for embolization of vessels in some endovascular treatments.

Terming that decision by Biosphere “abusive,“ Terumo Europe brought suit vs. Biosphere.

This past November, the Tribunal de Commerce of Pontoise ruled in Terumo Europe's favor, ordering Biosphere to pay Terumo EUR 553,288, plus legal fees and interest of EUR 8,000.

Terumo in a statement said that the embolization market “ remains an important strategic focus for its expansion in the interventional radiology field, thanks to a new distribution agreement signed in March 2003 with Biocompatibles International [Basingstoke, UK].“

Terumo, a global medical company with 2003 annual sales of more than $2 billion, manufactures a range of medical products, including cardiovascular systems, disposable medical devices, therapeutic catheters, IV solutions, blood bags, diabetes care systems and medical electronic products, in more than 150 countries.

BioSphere is focused on embolotherapy, the treatment of tumors and vascular malformations via occlusion of their blood supply.

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