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| Boston Scientific's Lotus TAVR--Courtesy of Boston Scientific |
Boston Scientific ($BSX) is alleging that Edwards' ($EW) Sapien 3 TAVR infringes its patents related to adaptive sealing technology in an intellectual-property lawsuit filed against the competitor in Germany.
Boston Scientific's CE-marked Lotus TAVR uses the technology. The company complains that Edwards' third-generation Sapien TAVR, launched in 2014 in Europe (and 2015 in the U.S.), deploys the feature as well.
"The Lotus Valve system was CE approved in October, 2013 and featured many innovative features including adaptive sealing technology, which is designed to reduce paravalvular leakage (PVL) and low PVL was demonstrated in BSC's CE mark trial," Boston Scientific spokesman Thomas Keppeler told MD+DI. "Edwards' Sapien 3 received CE approval in January of the following year and also uses an external seal which it claims significantly reduces PVL when compared to Edwards' earlier generation valves."
Thanks to FDA approval, Edwards' Sapien franchise (and Medtronic's ($MDT) CoreValve TAVRs) are well ahead of Boston Scientific and others companies who are only approved in Europe.
Edwards emailed a statement to FierceMedicalDevices in response to the lawsuit: "We respect the rights of all inventors to protect their innovations, however, we believe this suit based on a European patent issued very recently is without merit. We are disappointed that Boston Scientific has resorted to legal action in this matter, rather than sharing our focus on creating value through innovative therapies and enabling treatment for patients around the world."
The statement continues (with a subtle jab at the competitor): "It is unfortunate that Boston Scientific, as a more recent entrant into the TAVR field, is seeking to capitalize on our long-term efforts and gain greater presence through the court system."
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| Sapien 3 valve--Courtesy of Edwards Lifesciences |
In addition, Edwards said it holds the "seminal patents" for TAVR. The claim is not unfounded.
Soon after Medtronic's CoreValve received FDA approval in 2014 (thee years after the Sapien), a court put a preliminary injunction on sales of the device in the U.S. as a result of Edwards' patent infringement suit.
But the rivals agreed on a settlement before the injunction went into to affect. To settle the suit, Medtronic agreed to pay Edwards a hefty $750 million one-time payment and royalty payments of at least $40 million annually through 2022.
Now, Boston Scientific is looking to turn the tables on Edwards and gain ground in the intensively profitable (and competitive) TAVR arena for heart failure patients who are too frail for open heart surgery. The bigwigs are anticipating serving "intermediate-risk" patients soon, pending regulatory approvals and changes in clinical guidelines.
Boston Scientific disclosed its lawsuit in its Nov. 4 quarterly filing with the SEC.
- read Edwards' statement
- here's more from MD+DI