German CoreValve use on hold, as court injunction goes into effect

Shelley Wood

August 27, 2013

Irvine, CA - A court injunction preventing the sale of Medtronic's CoreValve in Germany went into effect yesterday, the manufacturer of the CoreValve's chief competitor, Edwards Lifesciences, announced Monday[1]. Edwards, which makes the Sapien XT transcatheter valve, says it has "reached out" to German doctors accustomed to using the CoreValve who don't have the necessary experience with the Sapien "to offer training and mentoring."

Last month, a German court ruled that Medtronic was infringing on the Edwards Spenser patent, issued an injunction prohibiting the sale of the CoreValve device, and ordered that all CoreValve products be removed from distribution channels. Since then, Edwards has provided the bond required to initiate the injunction.

In the press release issued yesterday, Edwards says it has provided for "exceptions" to the injunction so that physicians can access CoreValve transcatheter valves for use in instances where the Edwards Sapien XT valve is not indicated. Contacted by heart wire , Edwards spokesperson Sarah Huoh listed two types of patients in whom the CoreValve would still be permitted: patients deemed to need treatment via a subclavian approach, as well as patients with an aortic annulus larger than 28 mm.

According to estimates from Edwards and implanting physicians, approximately 70% to 80% of centers in Germany are already using the Sapien device.

Asked to comment, Medtronic spokesperson Kathleen Janasz told heart wire , "While Medtronic respectfully disagrees with the court's patent-infringement decision regarding Edwards's Spenser patent, Medtronic will abide by its ruling, which generally prohibits new importation and sales of the CoreValve device in Germany, among other specifics." As well, she said, "physicians and hospitals are able to treat patients with CoreValve System valves already owned by them and in their possession."

The exception to allow Medtronic to make its CoreValve System available for "compassionate use" in specific cases is a welcome decision for German interventionalists Dr Nikolaus Sarafoff and head of the department for transcatheter aortic-valve implantation (TAVI) Dr Julinda Mehilli (Klinikum der Universität Munich Grosshadern, Germany). They pointed out to heart wire in a joint email that patients undergoing TAVI are a heterogeneous population, both in terms of the type of involvement of the diseased aortic valve and the access-site suitability.

"The availability of two completely different prosthesis types—self-expandable and balloon-expandable prosthesis—enables treatment of a large number of patients through the less invasive transfemoral-assess route," they said. In particular, patients with less or no aortic-valve-cusp calcification; patients with a large aortic annulus having small femoral arteries; patients with some types of degenerated bioprosthesis; and those with severely reduced left ventricular function "are preferable candidates for a self-expandable prosthesis system such as the CoreValve," they wrote.

"However," they continued, "until the patent litigation is over it is estimated that the numbers of Core Valve implantations in Germany will go down. In our opinion, it is very important that the patients' health is not affected by these judicial conflicts and that clinicians may still use this valve in case it provides the best care for the patient."

Asked how this would affect sales or penetration of the CoreValve in the German market, Janasz said: "We don't break out sales by product or by country."

Medtronic is, of course, appealing the German court's decisions and, in a separate case, is challenging the validity of the Spenser patent (it is joined in this challenge by other valve makers). Janasz noted that it is only commercial sales of the CoreValve System that are affected (the Medtronic Engager transcatheter valve and the Melody Pulmonic transcatheter valve are unaffected) and only in Germany.

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