A decade-old company called Colibri Heart Valve is claiming in a lawsuit that Medtronic’s CoreValve line of TAVR devices are infringing on two of its patents.
Founded in 2010, Broomfield, Colo.–based Colibri boasts that its TAVI system is the only one using dry tissue technology to allow for a pre-mounted, pre-crimped, and pre-loaded heart valve, sterilized and ready-for-use. In a lawsuit filed yesterday in the U.S. District Court in Central California, the company claims that Medtronic’s CoreValve, CoreValve Evolut R, CoreValve Evolut Pro, and CoreValve Evolut Pro+ infringe on two of Colibri’s patents.
Medtronic media relations did not immediately have a comment.
One of the Colibri patents is for a “Percutaneous Replacement Heart Valve and a Delivery and Implementation System,” and the other is for a “Method of Controlled Release of a Percutaneous Replacement Heart Valve,” according to the lawsuit. The U.S. Patent and Trademark Office issued the patents in September 2015 and December 2014, respectively.
Colibri CEO Joseph Horn actually met with some Medtronic managers — under a non-disclosure agreement — in May 2014 to discuss the successful implementation of Colibri’s TAVI System in a patient, followed by a conference call with Medtronic in July 2014, according to the lawsuit. The company’s pending patent applications were apparently part of the discussion.
The FDA approved Medtronic’s original CoreValve system in the U.S. in 2014, with the next generation models coming out in later years as the medical device giant ramped up competition against Edwards Lifesciences (NYSE:EW) in the space. (In 2014, Medtronic agreed to pay Edwards $750 million to settle TAVR patent disputes.)
The Colibri lawsuit says of the CoreValve systems that like Colibri’s patented technology, the “leaflets are sutured onto a collapsible and expandable, multi-level, radiopaque stent with flared ends in a trumpet-like configuration.”